Trial Outcomes & Findings for Islet Transplantation Using Abatacept (NCT NCT00276250)
NCT ID: NCT00276250
Last Updated: 2016-07-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
75 days post-transplantation
Results posted on
2016-07-27
Participant Flow
Nine subjects signed informed consent. During evaluation, four participants were found ineligible for study inclusion. Five participants completed the evaluation process and were listed for an islet transplant
Participant milestones
| Measure |
Efalizumab Followed by Abatacept Regimen
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
|
Abatacept Regimen
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
|
Belatacept Regimen
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
1
|
0
|
|
Overall Study
COMPLETED
|
4
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Islet Transplantation Using Abatacept
Baseline characteristics by cohort
| Measure |
Efalizumab Followed by Abatacept Regimen
n=4 Participants
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
|
Abatacept Regimen
n=1 Participants
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
|
Belatacept Regimen
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
—
|
0 participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 participants
n=99 Participants
|
1 participants
n=107 Participants
|
—
|
5 participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
—
|
0 participants
n=7 Participants
|
|
Gender
Female
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
—
|
2 participants
n=7 Participants
|
|
Gender
Male
|
3 participants
n=99 Participants
|
0 participants
n=107 Participants
|
—
|
3 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
1 participants
n=107 Participants
|
—
|
5 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 75 days post-transplantationOutcome measures
| Measure |
Efalizumab Followed by Abatacept Regimen
n=4 Participants
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
|
Abatacept Regimen
n=1 Participants
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
|
Belatacept Regimen
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
|
|---|---|---|---|
|
The Number of Insulin-independent Subjects at Day 75 (± 5 Days) Following the First Islet Cell Transplantation
|
4 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: 1, 3, 6, 9,12,18 and 24 months post-transplantationParticipants who did not need to take insulin at 1, 3, 6, 9, 12, 18, and 24 months following islet transplantation
Outcome measures
| Measure |
Efalizumab Followed by Abatacept Regimen
n=4 Participants
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
|
Abatacept Regimen
n=1 Participants
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
|
Belatacept Regimen
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
|
|---|---|---|---|
|
Number of Insulin-independent Subjects Following Islet Transplantation
1 Month Post-Transplant
|
4 participants
|
0 participants
|
—
|
|
Number of Insulin-independent Subjects Following Islet Transplantation
3 Months Post-Transplant
|
4 participants
|
0 participants
|
—
|
|
Number of Insulin-independent Subjects Following Islet Transplantation
6 Months Post-Transplant
|
4 participants
|
0 participants
|
—
|
|
Number of Insulin-independent Subjects Following Islet Transplantation
9 Months Post-Transplant
|
3 participants
|
0 participants
|
—
|
|
Number of Insulin-independent Subjects Following Islet Transplantation
12 Months Post-Transplant
|
3 participants
|
0 participants
|
—
|
|
Number of Insulin-independent Subjects Following Islet Transplantation
18 Months Post-Transplant
|
2 participants
|
0 participants
|
—
|
|
Number of Insulin-independent Subjects Following Islet Transplantation
24 Months Post-Transplant
|
2 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: 6 months post-transplantationPopulation: The HbA1C for the subject in the abatacept arm was above the threshold (6.5%) for this measure.
HbA1C was assessed in the subjects 6 months after transplantation and the number of subjects with values less than 6.5% was recorded which indicated better control of blood glucose levels.
Outcome measures
| Measure |
Efalizumab Followed by Abatacept Regimen
n=4 Participants
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
|
Abatacept Regimen
n=1 Participants
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
|
Belatacept Regimen
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
|
|---|---|---|---|
|
Number of Subjects With HbA1C Less Than 6.5%
|
4 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: 12 months post-transplantationHbA1C was assessed in the subjects 12 months after transplantation and the number of subjects with levels \< 6.5% was recorded which indicated better control of blood glucose levels.
Outcome measures
| Measure |
Efalizumab Followed by Abatacept Regimen
n=4 Participants
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
|
Abatacept Regimen
n=1 Participants
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
|
Belatacept Regimen
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
|
|---|---|---|---|
|
Number of Subjects With HbA1C Levels < 6.5%
|
3 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: 24 months post-transplantPopulation: One participant in the Efalizumab followed by abatacept regimen arm had partial graft function and withdrew from the study at 18 months post-transplantation (prior to this time point of assessment).
HbA1C was assessed in the subjects 24 months after transplantation and the number of subjects with levels \< 6.5% was recorded which indicated better control of blood glucose levels.
Outcome measures
| Measure |
Efalizumab Followed by Abatacept Regimen
n=3 Participants
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
|
Abatacept Regimen
n=1 Participants
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
|
Belatacept Regimen
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
|
|---|---|---|---|
|
Number of Subjects With HbA1C < 6.5%
|
2 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: 36 months post-transplantationPopulation: Two participants in the Efalizumab followed by abatacept regimen arm were terminated prior to this time point due to islet graft failure; another one withdrew as they did not want to change to abatacept. The single participant in the Abatacept arm withdrew after graft failure which occurred at 6months post-transplantation.
HbA1C was assessed in the subjects 36 months after transplantation and the number of subjects with values \< 6.5% was recorded which indicated better control of blood glucose levels.
Outcome measures
| Measure |
Efalizumab Followed by Abatacept Regimen
n=1 Participants
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
|
Abatacept Regimen
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
|
Belatacept Regimen
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
|
|---|---|---|---|
|
Number of Subjects With HbA1C < 6.5%
|
1 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1, 3, 6, 9,12,18 and 24 months post-transplantationPopulation: C-Peptide values were not obtained for 2 participants in the Efalizumab followed by abatacept arm at the 18 and 24 months post-transplant timepoints.
The number of subjects exhibiting C-peptide levels ≥ 0.5 ng/mL was recorded.
Outcome measures
| Measure |
Efalizumab Followed by Abatacept Regimen
n=4 Participants
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
|
Abatacept Regimen
n=1 Participants
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
|
Belatacept Regimen
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
|
|---|---|---|---|
|
Number of Participants With Endogenous Insulin Production Post-transplant, Assessed by Fasting C-peptide Levels
1 Month Post-Transplant
|
4 participants
|
1 participants
|
—
|
|
Number of Participants With Endogenous Insulin Production Post-transplant, Assessed by Fasting C-peptide Levels
3 Months Post-Transplant
|
4 participants
|
0 participants
|
—
|
|
Number of Participants With Endogenous Insulin Production Post-transplant, Assessed by Fasting C-peptide Levels
6 Months Post-Transplant
|
4 participants
|
0 participants
|
—
|
|
Number of Participants With Endogenous Insulin Production Post-transplant, Assessed by Fasting C-peptide Levels
9 Months Post-Transplant
|
4 participants
|
0 participants
|
—
|
|
Number of Participants With Endogenous Insulin Production Post-transplant, Assessed by Fasting C-peptide Levels
12 Months Post-Transplant
|
4 participants
|
0 participants
|
—
|
|
Number of Participants With Endogenous Insulin Production Post-transplant, Assessed by Fasting C-peptide Levels
18 Months Post-Transpla
|
2 participants
|
0 participants
|
—
|
|
Number of Participants With Endogenous Insulin Production Post-transplant, Assessed by Fasting C-peptide Levels
24 Months Post-Transplant
|
2 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: 1, 3, 6, 9,12,18 and 24 months post-transplantationPopulation: C-Peptide values were not obtained for 2 participants in the Efalizumab followed by abatacept arm for 18 and 24 months post-transplant
The number of study participants who have detectable C-peptide levels after stimulation from a Mixed Meal Test. An increase of C-peptide indicates that insulin is being released normally in response to food consumption.
Outcome measures
| Measure |
Efalizumab Followed by Abatacept Regimen
n=4 Participants
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
|
Abatacept Regimen
n=1 Participants
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
|
Belatacept Regimen
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
|
|---|---|---|---|
|
The Number of Study Participants Exhibiting a Successful Response to a Standard Mixed Meal Test, Measured by Stimulated C-peptide Levels After Islet Transplant.
1 Month Post-Transplant
|
4 participants
|
0 participants
|
—
|
|
The Number of Study Participants Exhibiting a Successful Response to a Standard Mixed Meal Test, Measured by Stimulated C-peptide Levels After Islet Transplant.
3 Months Post-Transplant
|
4 participants
|
0 participants
|
—
|
|
The Number of Study Participants Exhibiting a Successful Response to a Standard Mixed Meal Test, Measured by Stimulated C-peptide Levels After Islet Transplant.
6 Months Post-Transplant
|
4 participants
|
0 participants
|
—
|
|
The Number of Study Participants Exhibiting a Successful Response to a Standard Mixed Meal Test, Measured by Stimulated C-peptide Levels After Islet Transplant.
9 Months Post-Transplant
|
3 participants
|
0 participants
|
—
|
|
The Number of Study Participants Exhibiting a Successful Response to a Standard Mixed Meal Test, Measured by Stimulated C-peptide Levels After Islet Transplant.
12 Months Post-Transplant
|
3 participants
|
0 participants
|
—
|
|
The Number of Study Participants Exhibiting a Successful Response to a Standard Mixed Meal Test, Measured by Stimulated C-peptide Levels After Islet Transplant.
18 Months Post-Transpla
|
2 participants
|
0 participants
|
—
|
|
The Number of Study Participants Exhibiting a Successful Response to a Standard Mixed Meal Test, Measured by Stimulated C-peptide Levels After Islet Transplant.
24 Months Post-Transplant
|
2 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: 24 months after transplantPopulation: One subject in the Efalizumab followed by abatacept regimen arm withdrew from the the study at 18 months post-transplantation and therefore did not have the 24-month assessments.
Renal function was assessed by measuring levels of serum creatinine. Normal values range from 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women.
Outcome measures
| Measure |
Efalizumab Followed by Abatacept Regimen
n=4 Participants
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
|
Abatacept Regimen
n=1 Participants
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
|
Belatacept Regimen
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
|
|---|---|---|---|
|
Number of Subjects With Normal Renal Function, as Measured by Serum Creatinine Levels
|
3 participants
|
1 participants
|
—
|
Adverse Events
Efalizumab Followed by Abatacept Regimen
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Abatacept Regimen
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Belatacept Regimen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Efalizumab Followed by Abatacept Regimen
n=4 participants at risk
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
|
Abatacept Regimen
n=1 participants at risk
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
|
Belatacept Regimen
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
|
|---|---|---|---|
|
Infections and infestations
Fever with cough and chills
|
25.0%
1/4 • Number of events 1 • Adverse events data will be collected from the point of islet transplantation throughout the duration of study participation, an average of 2 years.
All adverse events will be recorded, regardless of the severity or relationship to study medication or procedure unless otherwise stated in the CIT-TCAE v. 3.0. Subjects experiencing adverse events will be treated appropriately and observed at suitable intervals until the events resolve or stabilize.
|
0.00%
0/1 • Adverse events data will be collected from the point of islet transplantation throughout the duration of study participation, an average of 2 years.
All adverse events will be recorded, regardless of the severity or relationship to study medication or procedure unless otherwise stated in the CIT-TCAE v. 3.0. Subjects experiencing adverse events will be treated appropriately and observed at suitable intervals until the events resolve or stabilize.
|
—
0/0 • Adverse events data will be collected from the point of islet transplantation throughout the duration of study participation, an average of 2 years.
All adverse events will be recorded, regardless of the severity or relationship to study medication or procedure unless otherwise stated in the CIT-TCAE v. 3.0. Subjects experiencing adverse events will be treated appropriately and observed at suitable intervals until the events resolve or stabilize.
|
|
Nervous system disorders
Vertigo
|
25.0%
1/4 • Number of events 1 • Adverse events data will be collected from the point of islet transplantation throughout the duration of study participation, an average of 2 years.
All adverse events will be recorded, regardless of the severity or relationship to study medication or procedure unless otherwise stated in the CIT-TCAE v. 3.0. Subjects experiencing adverse events will be treated appropriately and observed at suitable intervals until the events resolve or stabilize.
|
0.00%
0/1 • Adverse events data will be collected from the point of islet transplantation throughout the duration of study participation, an average of 2 years.
All adverse events will be recorded, regardless of the severity or relationship to study medication or procedure unless otherwise stated in the CIT-TCAE v. 3.0. Subjects experiencing adverse events will be treated appropriately and observed at suitable intervals until the events resolve or stabilize.
|
—
0/0 • Adverse events data will be collected from the point of islet transplantation throughout the duration of study participation, an average of 2 years.
All adverse events will be recorded, regardless of the severity or relationship to study medication or procedure unless otherwise stated in the CIT-TCAE v. 3.0. Subjects experiencing adverse events will be treated appropriately and observed at suitable intervals until the events resolve or stabilize.
|
Other adverse events
| Measure |
Efalizumab Followed by Abatacept Regimen
n=4 participants at risk
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
|
Abatacept Regimen
n=1 participants at risk
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
|
Belatacept Regimen
Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
2/4 • Adverse events data will be collected from the point of islet transplantation throughout the duration of study participation, an average of 2 years.
All adverse events will be recorded, regardless of the severity or relationship to study medication or procedure unless otherwise stated in the CIT-TCAE v. 3.0. Subjects experiencing adverse events will be treated appropriately and observed at suitable intervals until the events resolve or stabilize.
|
0.00%
0/1 • Adverse events data will be collected from the point of islet transplantation throughout the duration of study participation, an average of 2 years.
All adverse events will be recorded, regardless of the severity or relationship to study medication or procedure unless otherwise stated in the CIT-TCAE v. 3.0. Subjects experiencing adverse events will be treated appropriately and observed at suitable intervals until the events resolve or stabilize.
|
—
0/0 • Adverse events data will be collected from the point of islet transplantation throughout the duration of study participation, an average of 2 years.
All adverse events will be recorded, regardless of the severity or relationship to study medication or procedure unless otherwise stated in the CIT-TCAE v. 3.0. Subjects experiencing adverse events will be treated appropriately and observed at suitable intervals until the events resolve or stabilize.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • Adverse events data will be collected from the point of islet transplantation throughout the duration of study participation, an average of 2 years.
All adverse events will be recorded, regardless of the severity or relationship to study medication or procedure unless otherwise stated in the CIT-TCAE v. 3.0. Subjects experiencing adverse events will be treated appropriately and observed at suitable intervals until the events resolve or stabilize.
|
100.0%
1/1 • Adverse events data will be collected from the point of islet transplantation throughout the duration of study participation, an average of 2 years.
All adverse events will be recorded, regardless of the severity or relationship to study medication or procedure unless otherwise stated in the CIT-TCAE v. 3.0. Subjects experiencing adverse events will be treated appropriately and observed at suitable intervals until the events resolve or stabilize.
|
—
0/0 • Adverse events data will be collected from the point of islet transplantation throughout the duration of study participation, an average of 2 years.
All adverse events will be recorded, regardless of the severity or relationship to study medication or procedure unless otherwise stated in the CIT-TCAE v. 3.0. Subjects experiencing adverse events will be treated appropriately and observed at suitable intervals until the events resolve or stabilize.
|
|
Hepatobiliary disorders
Elevated Liver Enzymes
|
50.0%
2/4 • Adverse events data will be collected from the point of islet transplantation throughout the duration of study participation, an average of 2 years.
All adverse events will be recorded, regardless of the severity or relationship to study medication or procedure unless otherwise stated in the CIT-TCAE v. 3.0. Subjects experiencing adverse events will be treated appropriately and observed at suitable intervals until the events resolve or stabilize.
|
100.0%
1/1 • Adverse events data will be collected from the point of islet transplantation throughout the duration of study participation, an average of 2 years.
All adverse events will be recorded, regardless of the severity or relationship to study medication or procedure unless otherwise stated in the CIT-TCAE v. 3.0. Subjects experiencing adverse events will be treated appropriately and observed at suitable intervals until the events resolve or stabilize.
|
—
0/0 • Adverse events data will be collected from the point of islet transplantation throughout the duration of study participation, an average of 2 years.
All adverse events will be recorded, regardless of the severity or relationship to study medication or procedure unless otherwise stated in the CIT-TCAE v. 3.0. Subjects experiencing adverse events will be treated appropriately and observed at suitable intervals until the events resolve or stabilize.
|
|
Blood and lymphatic system disorders
Leukopenia
|
25.0%
1/4 • Adverse events data will be collected from the point of islet transplantation throughout the duration of study participation, an average of 2 years.
All adverse events will be recorded, regardless of the severity or relationship to study medication or procedure unless otherwise stated in the CIT-TCAE v. 3.0. Subjects experiencing adverse events will be treated appropriately and observed at suitable intervals until the events resolve or stabilize.
|
100.0%
1/1 • Adverse events data will be collected from the point of islet transplantation throughout the duration of study participation, an average of 2 years.
All adverse events will be recorded, regardless of the severity or relationship to study medication or procedure unless otherwise stated in the CIT-TCAE v. 3.0. Subjects experiencing adverse events will be treated appropriately and observed at suitable intervals until the events resolve or stabilize.
|
—
0/0 • Adverse events data will be collected from the point of islet transplantation throughout the duration of study participation, an average of 2 years.
All adverse events will be recorded, regardless of the severity or relationship to study medication or procedure unless otherwise stated in the CIT-TCAE v. 3.0. Subjects experiencing adverse events will be treated appropriately and observed at suitable intervals until the events resolve or stabilize.
|
|
Infections and infestations
Increased Epstein-Barr Viral load assessed by Polymerase Chain Reaction
|
75.0%
3/4 • Adverse events data will be collected from the point of islet transplantation throughout the duration of study participation, an average of 2 years.
All adverse events will be recorded, regardless of the severity or relationship to study medication or procedure unless otherwise stated in the CIT-TCAE v. 3.0. Subjects experiencing adverse events will be treated appropriately and observed at suitable intervals until the events resolve or stabilize.
|
0.00%
0/1 • Adverse events data will be collected from the point of islet transplantation throughout the duration of study participation, an average of 2 years.
All adverse events will be recorded, regardless of the severity or relationship to study medication or procedure unless otherwise stated in the CIT-TCAE v. 3.0. Subjects experiencing adverse events will be treated appropriately and observed at suitable intervals until the events resolve or stabilize.
|
—
0/0 • Adverse events data will be collected from the point of islet transplantation throughout the duration of study participation, an average of 2 years.
All adverse events will be recorded, regardless of the severity or relationship to study medication or procedure unless otherwise stated in the CIT-TCAE v. 3.0. Subjects experiencing adverse events will be treated appropriately and observed at suitable intervals until the events resolve or stabilize.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place