Trial Outcomes & Findings for Intravenous Interferon During Liver Transplant (NCT NCT01192698)
NCT ID: NCT01192698
Last Updated: 2022-04-21
Results Overview
Will measure mean HCV RNA levels 4 weeks after liver transplant
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
4 weeks after liver transplant
Results posted on
2022-04-21
Participant Flow
Participant milestones
| Measure |
IV Interferon
IV interferon oral ribavirin
IV interferon: IV interferon 5MU during anhepatic phase
|
no Treatment
standard of care
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
5
|
|
Overall Study
COMPLETED
|
10
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intravenous Interferon During Liver Transplant
Baseline characteristics by cohort
| Measure |
IV Interferon
n=10 Participants
IV interferon oral ribavirin
Aims The purpose of this study was to determine the safety and effect of intravenous interferon (IFN) during the anhepatic phase of LT on hepatitis C viral load. Methods Fifteen consecutive subjects undergoing liver transplant for hepatitis C cirrhosis were enrolled in the study, ten of which received study drug and five subjects served as controls. Cases received weight-based ribavirin and subcutaneous IFN at time of incision followed by intravenous IFN at the start of the anhepatic phase.
|
no Treatment
n=5 Participants
standard of care for liver transplant
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
57 years
n=99 Participants
|
55.8 years
n=107 Participants
|
56.4 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
5 participants
n=107 Participants
|
15 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 weeks after liver transplantWill measure mean HCV RNA levels 4 weeks after liver transplant
Outcome measures
| Measure |
IV Interferon
n=10 Participants
IV interferon oral ribavirin
Aims The purpose of this study was to determine the safety and effect of intravenous interferon (IFN) during the anhepatic phase of LT on hepatitis C viral load. Methods Fifteen consecutive subjects undergoing liver transplant for hepatitis C cirrhosis were enrolled in the study, ten of which received study drug and five subjects served as controls. Cases received weight-based ribavirin and subcutaneous IFN at time of incision followed by intravenous IFN at the start of the anhepatic phase.
|
no Treatment
n=5 Participants
standard of care for liver transplant
|
|---|---|---|
|
HCV RNA Result
|
924,082 IU/ml
Standard Deviation 53,000
|
3,731,749 IU/ml
Standard Deviation 64,000
|
Adverse Events
IV Interferon
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
no Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IV Interferon
n=10 participants at risk
IV interferon oral ribavirin
IV interferon: IV interferon 5MU during anhepatic phase
|
no Treatment
n=5 participants at risk
standard of care for liver transplant
|
|---|---|---|
|
Cardiac disorders
Flash pulmonary edema
|
10.0%
1/10 • Number of events 1
|
0.00%
0/5
|
|
Immune system disorders
Acute cellular rejection
|
10.0%
1/10 • Number of events 1
|
0.00%
0/5
|
|
Blood and lymphatic system disorders
Increased leukopenia requiring administration of granulocyte colony stimulating factor
|
10.0%
1/10 • Number of events 1
|
0.00%
0/5
|
Other adverse events
| Measure |
IV Interferon
n=10 participants at risk
IV interferon oral ribavirin
IV interferon: IV interferon 5MU during anhepatic phase
|
no Treatment
n=5 participants at risk
standard of care for liver transplant
|
|---|---|---|
|
General disorders
pulmonary edema
|
10.0%
1/10 • Number of events 1
|
0.00%
0/5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place