Trial Outcomes & Findings for Stem Cell Transplantation in Idiopathic Inflammatory Myopathy Diseases (NCT NCT00278564)
NCT ID: NCT00278564
Last Updated: 2018-08-06
Results Overview
Survival
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
7 participants
Primary outcome timeframe
up to 5 years
Results posted on
2018-08-06
Participant Flow
Participant milestones
| Measure |
Hematopoietic Stem Cell Transplantation
Intervention as autologous hematopoietic stem cell transplantation after conditioning regimen
Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Hematopoietic Stem Cell Transplantation
Intervention as autologous hematopoietic stem cell transplantation after conditioning regimen
Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation
|
|---|---|
|
Overall Study
Lack of Efficacy
|
4
|
Baseline Characteristics
Stem Cell Transplantation in Idiopathic Inflammatory Myopathy Diseases
Baseline characteristics by cohort
| Measure |
Hematopoietic Stem Cell Transplantation
n=7 Participants
Intervention as hematopoietic stem cells transplantation after conditioning regimen: Autologous hematopoietic stem cells will be injected after conditioning regimen
Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: up to 5 yearsPopulation: All participants who underwent stem cell transplantation
Survival
Outcome measures
| Measure |
Hematopoietic Stem Cell Transplantation
n=7 Participants
Intervention as autologous hematopoietic stem cell transplantation after conditioning regimen
Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation
|
|---|---|
|
Survival
|
7 Participants
|
Adverse Events
Hematopoietic Stem Cell Transplantation
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hematopoietic Stem Cell Transplantation
n=7 participants at risk
Intervention as autologous hematopoietic stem cell transplantation after conditioning regimen
Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation
|
|---|---|
|
Infections and infestations
Sinusitis
|
28.6%
2/7 • Number of events 2 • 6 months, 1 year, then yearly up to 5 years post transplant
|
|
General disorders
Viral infection
|
14.3%
1/7 • Number of events 2 • 6 months, 1 year, then yearly up to 5 years post transplant
|
|
General disorders
hypokalemia
|
14.3%
1/7 • Number of events 1 • 6 months, 1 year, then yearly up to 5 years post transplant
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place