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NCT01909401 · ClinicalTrials.gov registry record · Early Phase 1
Pilot Study With Peginterferon, Ribavirin, and Boceprevir Prior to Transplantation to Clear Virus in Hepatitis C Genotype 1 Infected Individuals Undergoing Orthotopic Liver Transplantation
A Early Phase 1 study, sponsored by Indiana University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 1
- Enrollment target
NCT01909401 is a Early Phase 1 study that has completed, run by Indiana University. The registered enrollment target is 1 participants.
The verdict
NCT01909401, a Early Phase 1 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
Currently, there is no treatment standard for use of anti-HCV (hepatitic C virus) medications for those preparing for a liver transplant. The purpose of this study is to determine whether those individuals who require liver transplantation for Hepatitis C, genotype I, who are undergoing liver transplantation may successfully get rid of their virus before the transplant by taking three medicines, peginterferon, ribavirin, and boceprevir, up until the time of the liver transplant surgery. If successful, the Hepatitis C virus will not re-infect the new liver that they receive and they will not require therapy for Hepatitis C after liver transplantation. This study involves the use of peginterferon alfa-2b, ribavirin, and boceprevir, all of which are approved for the treatment of genotype I Hepatitis C. Hypothesis: The addition of boceprevir to peginterferon alfa-2b and ribavirin in patients with Hepatitis C genotype 1 with or without hepatocellular carcinoma undergoing orthotopic liver transplantation will lead to rapid HCV RNA clearance of genotype I infected individuals. Transplantation with anhepatic boceprevir will prevent reinfection of the new transplanted graft and prevent graft infection posttransplantation.
Interventions
- DRUG boceprevir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2013-06 |
| Est. Completion | 2014-07 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01909401
The ClinicalTrials.gov registry entry for NCT01909401 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which boceprevir is the first listed.
NCT01909401 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01909401 about?
NCT01909401 is a clinical study titled "Pilot Study With Peginterferon, Ribavirin, and Boceprevir Prior to Transplantation to Clear Virus in Hepatitis C Genotype 1 Infected Individuals Undergoing Orthotopic Liver Transplantation". Currently, there is no treatment standard for use of anti-HCV (hepatitic C virus) medications for those preparing for a liver transplant. The purpose of this study is to determine whether those individuals who require liver transplantation for Hepatitis C, genotype I, who are undergoing liver transp...
What is the current status of trial NCT01909401?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 1 participants. The study started on 2013-06. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01909401?
The interventions under investigation include: boceprevir (DRUG).
Who is sponsoring clinical trial NCT01909401?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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