Trial Outcomes & Findings for Pre-Transplant Treatment to Prevent Recurrence of Hepatitis C After Liver Transplantation (NCT NCT00135798)
NCT ID: NCT00135798
Last Updated: 2013-04-23
Results Overview
Post-transplant virologic response (pTVR) defined as undetectable HCV RNA at week 12 after liver transplantation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
79 participants
Primary outcome timeframe
3 months post-transplant
Results posted on
2013-04-23
Participant Flow
Persons were enrolled from October 2005 to January 2009, and followed through December 2009. Patients were enrolled at 7 clinical transplant centers in the United States.
No pre-assignment events. Randomization occurred immediately after enrollment.
Participant milestones
| Measure |
Standard Clinical Care: Genotypes 1, 4, 6
Subjects randomized to non-treatment group 1:2 compared to treatment group.
|
LADR Treatment: Genotypes 1, 4, 6
Low Accelerating Dose Regimen (LADR): Subjects randomized to LADR treatment group 2:1 compared to standard care.
|
LADR Treatment: Genotypes 2 or 3
Patients in this subgroup were all assigned to LADR treatment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
31
|
32
|
|
Overall Study
COMPLETED
|
16
|
31
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pre-Transplant Treatment to Prevent Recurrence of Hepatitis C After Liver Transplantation
Baseline characteristics by cohort
| Measure |
Standard Clinical Care: Genotypes 1, 4, 6
n=16 Participants
Subjects randomized to non-treatment group 1:2 compared to treatment group.
|
LADR Treatment: Genotypes 1, 4, 6
n=31 Participants
Low Accelerating Dose Regimen (LADR): Subjects randomized to LADR treatment group 2:1 compared to standard care.
|
LADR Treatment: Genotypes 2 or 3
n=32 Participants
Patients in this subgroup were all assigned to LADR treatment.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Age Continuous
|
56.1 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
54.6 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
56.6 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 6.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
31 participants
n=7 Participants
|
32 participants
n=5 Participants
|
79 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 months post-transplantPopulation: Intent-to-Treat (ITT) analyses of Transplanted patients assigned to treatment. Outcome is pTVR (post-transplant viral response)
Post-transplant virologic response (pTVR) defined as undetectable HCV RNA at week 12 after liver transplantation.
Outcome measures
| Measure |
Standard Care Group: Genotypes 1, 4, 6
n=13 Participants
Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
|
LADR Treatment Group: Genotypes 1, 4, 6
n=24 Participants
Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
|
LADR Treatment Group: Genotypes 2, 3
n=22 Participants
All patients with Genotypes 2,3 received LADR treatment.
|
|---|---|---|---|
|
Patients Who Are Negative for Hepatitis C Virus (HCV) RNA at 3 Months Post-transplant: Intent-to-Treat Analysis (ITT)
|
0 participants
Interval 0.0 to
|
5 participants
Interval 0.07 to 0.42
|
6 participants
Interval 0.11 to 0.5
|
PRIMARY outcome
Timeframe: 3 months post-transplantPopulation: Per-Protocol (PP) analyses of Transplanted patients who received treatment. Outcome is pTVR (post-transplant viral response)
Post-transplant virologic response (pTVR) defined as undetectable HCV RNA at week 12 after liver transplantation, analysed among patients who received treatment.
Outcome measures
| Measure |
Standard Care Group: Genotypes 1, 4, 6
n=13 Participants
Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
|
LADR Treatment Group: Genotypes 1, 4, 6
n=23 Participants
Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
|
LADR Treatment Group: Genotypes 2, 3
n=21 Participants
All patients with Genotypes 2,3 received LADR treatment.
|
|---|---|---|---|
|
Patients Who Are Negative for HCV RNA at 3 Months Post-transplant: Per-Protocol Analysis (PP)
|
0 participants
|
5 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Pre-transplant and 3 months post-transplantPopulation: All study patients
Intent-to-Treat (ITT) analyses of all patients. Combined Virologic Response (CVR), which includes both sustained virologic response pre-transplant (SVR) and post-transplant virologic response (pTVR)
Outcome measures
| Measure |
Standard Care Group: Genotypes 1, 4, 6
n=16 Participants
Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
|
LADR Treatment Group: Genotypes 1, 4, 6
n=31 Participants
Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
|
LADR Treatment Group: Genotypes 2, 3
n=32 Participants
All patients with Genotypes 2,3 received LADR treatment.
|
|---|---|---|---|
|
Patients With Combined Virologic Response (CVR): Intent-to-Treat Analyses (ITT)
|
1 participants
|
6 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Pre-transplant and 3 months post-transplantPopulation: All study patients
Per-Protocol (PP) analyses of all patients. Combined Virologic Response (CVR)includes both sustained virologic response pre-transplant (SVR) and post-transplant virologic response (pTVR), analysed among patients who received treatment.
Outcome measures
| Measure |
Standard Care Group: Genotypes 1, 4, 6
n=20 Participants
Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
|
LADR Treatment Group: Genotypes 1, 4, 6
n=30 Participants
Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
|
LADR Treatment Group: Genotypes 2, 3
n=29 Participants
All patients with Genotypes 2,3 received LADR treatment.
|
|---|---|---|---|
|
Patients With Combined Virologic Response (CVR): Per-Protocol Analysis (PP)
|
0 participants
|
7 participants
|
6 participants
|
Adverse Events
Standard Clinical Care: Genotypes 1, 4, 6
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
LADR Treatment (All Genotypes)
Serious events: 40 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Clinical Care: Genotypes 1, 4, 6
n=20 participants at risk
Subjects who received no LADR treatment (Per Protocol analysis)
|
LADR Treatment (All Genotypes)
n=59 participants at risk
This group combines all who received LADR treatment (Per Protocol analysis) for all Genotypes 1,4,6 and 2,3
|
|---|---|---|
|
Hepatobiliary disorders
Post-LT (first 30 days) Rejection
|
0.00%
0/13 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
2.3%
1/44 • Number of events 1 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
|
Surgical and medical procedures
Post-LT (first 30 days) Surgical complication
|
0.00%
0/13 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
2.3%
1/44 • Number of events 2 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
|
Infections and infestations
Post-LT (30 days-1 year) Infection
|
23.1%
3/13 • Number of events 3 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
15.9%
7/44 • Number of events 9 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
|
Hepatobiliary disorders
Post-LT (30 days-1 year) Liver-related
|
0.00%
0/13 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
2.3%
1/44 • Number of events 2 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
|
Hepatobiliary disorders
Post-LT (30 days-1 year) Rejection
|
0.00%
0/13 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
0.00%
0/44 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
|
Surgical and medical procedures
Post-LT (30 days-1 year) Surgical complication
|
0.00%
0/13 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
13.6%
6/44 • Number of events 8 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
|
General disorders
Post-LT (first 30 days) Other
|
7.7%
1/13 • Number of events 1 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
13.6%
6/44 • Number of events 7 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
|
Blood and lymphatic system disorders
Post-LT (30 days-1 year) Cytopenia
|
7.7%
1/13 • Number of events 2 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
0.00%
0/44 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
|
General disorders
Death
|
10.0%
2/20 • Number of events 2 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
15.3%
9/59 • Number of events 9 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
|
Blood and lymphatic system disorders
Pre-LT Cytopenia
|
0.00%
0/20 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
13.6%
8/59 • Number of events 11 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
|
Infections and infestations
Pre-LT Infection
|
0.00%
0/20 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
5.1%
3/59 • Number of events 7 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
|
Hepatobiliary disorders
Pre-LT Liver-related
|
15.0%
3/20 • Number of events 3 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
10.2%
6/59 • Number of events 8 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
|
General disorders
Pre-LT Other
|
5.0%
1/20 • Number of events 1 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
16.9%
10/59 • Number of events 11 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
|
Blood and lymphatic system disorders
Post-LT (first 30 days) Cytopenia
|
0.00%
0/13 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
0.00%
0/44 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
|
Infections and infestations
Post-LT (first 30 days) Infection
|
0.00%
0/13 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
6.8%
3/44 • Number of events 4 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
|
Hepatobiliary disorders
Post-LT (first 30 days) Liver-related
|
7.7%
1/13 • Number of events 1 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
6.8%
3/44 • Number of events 3 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
|
General disorders
Post-LT (30 days-1 year) Other
|
15.4%
2/13 • Number of events 2 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
22.7%
10/44 • Number of events 13 • Serious Adverse Events (SAE) were collected pre-transplant, and through 1 year post-transplant.
Other \[non-serious\] adverse events were not collected or assessed as part of this study.
|
Other adverse events
Adverse event data not reported
Additional Information
Gregory T. Everson, M.D., Director of Hepatology
University Colorado, Denver
Phone: 720-848-2245
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place