Phase 2
N=79
Pre-Transplant Treatment to Prevent Recurrence of Hepatitis C After Liver Transplantation
Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT00135798 ↗Enrolled (actual)
79
Serious AEs
64.6%
Results posted
Apr 2013
Primary outcome: Primary: Patients Who Are Negative for Hepatitis C Virus (HCV) RNA at 3 Months Post-transplant: Intent-to-Treat Analysis (ITT) — 0; 5; 6 participants — p=0.0477
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LADR Treatment (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients Who Are Negative for Hepatitis C Virus (HCV) RNA at 3 Months Post-transplant: Intent-to-Treat Analysis (ITT) |
0; 5; 6 | 0.0477 sig |
| PRIMARY Patients Who Are Negative for HCV RNA at 3 Months Post-transplant: Per-Protocol Analysis (PP) |
0; 5; 6 | 0.0274 sig |
| SECONDARY Patients With Combined Virologic Response (CVR): Intent-to-Treat Analyses (ITT) |
1; 6; 6 | 0.2014 |
| SECONDARY Patients With Combined Virologic Response (CVR): Per-Protocol Analysis (PP) |
0; 7; 6 | 0.0153 sig |
Summary
The purpose of this study is to learn if pre-liver transplant treatment, using peginterferon plus ribavirin, will clear hepatitis C virus (HCV) RNA from the blood in HCV-infected recipients and reduce the risk of recurrent HCV and allograft hepatitis following liver transplant.
Eligibility Criteria
Inclusion Criteria
- Adult (18 or older)
- LDLT candidate
- HCV RNA positive
- Expected time on treatment is at least 12 weeks
- Candidates for DDLT who are listed for transplantation and meet UNOS criteria for MELD upgrade for HCC
Exclusion Criteria
- Severe cytopenia (polymorphonuclear (PMN) leukocytes 20. Patients with laboratory MELD score 21-25 may be enrolled if deemed appropriate by the site investigator
- Serum creatinine >2.2 mg/dL
Data sourced from ClinicalTrials.gov (NCT00135798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.