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NCT01821963 · ClinicalTrials.gov registry record · Phase 3
Telaprevir Plus Standard of Care (SOC) in HCV Associated Hepatocellular Carcinoma (HCC)
A Phase 3 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1
- Enrollment target
NCT01821963: Clinical Trial Phase 3 study, sponsored by M.D. Anderson Cancer Center.
NCT01821963 is a Phase 3 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 1 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01821963, a Phase 3 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if the antiviral combination of telaprevir, pegylated Interferon Alfa 2a (PegIFN alfa-2a) and ribavirin (RBV) can prevent the virus from coming back after the liver transplant. Telaprevir, PegIFN alfa-2a, and RBV are different antiviral drugs that work in combination at different stages of the HCV infection to stop the virus.
Primary Outcome
The primary endpoint is number of participants with undetectable viral load at 12 weeks post-transplant (Post-transplant virological response, (PTVR)) which is defined as undetectable Hepatitis C Virus ribonucleic acid (HCV-RNA) 12 weeks after liver transplantation). In order to have undetectable HCV RNA viral load after transplant, participants need to have undetectable viral load before the liver transplant. Response rate based on the modified intent-to-treat (ITT) population where ITT popula
Interventions
- DRUG Ribavirin
- DRUG Telaprevir
- DRUG Pegylated Interferon Alfa 2a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2013-04 |
| Est. Completion | 2014-02 |
| Phase | Phase 3 |
Why NCT01821963 stopped before completion
NCT01821963 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 3 interventions - of which Ribavirin is the first listed.
NCT01821963 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01821963 about?
NCT01821963 is a clinical study titled "Telaprevir Plus Standard of Care (SOC) in HCV Associated Hepatocellular Carcinoma (HCC)". The goal of this clinical research study is to learn if the antiviral combination of telaprevir, pegylated Interferon Alfa 2a (PegIFN alfa-2a) and ribavirin (RBV) can prevent the virus from coming back after the liver transplant. Telaprevir, PegIFN alfa-2a, and RBV are different antiviral drugs tha...
What is the current status of trial NCT01821963?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1 participants. The study started on 2013-04. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01821963?
The interventions under investigation include: Ribavirin (DRUG), Telaprevir (DRUG), Pegylated Interferon Alfa 2a (DRUG).
Who is sponsoring clinical trial NCT01821963?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01821963's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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