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NCT01532908 · ClinicalTrials.gov registry record · Phase 2
Open Label Study of the Efficacy and Safety of MBL-HCV1 in Combination With Oral Direct-Acting Antivirals in Patients Undergoing Liver Transplantation for Hepatitis C
A Phase 2 study, sponsored by MassBiologics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT01532908: Clinical Trial Phase 2 study, sponsored by MassBiologics.
NCT01532908 is a Phase 2 study that was terminated before completion, run by MassBiologics. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01532908, a Phase 2 study, was terminated before completion, sponsored by MassBiologics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
The purpose of this study is to assess efficacy of a human monoclonal antibody against Hepatitis C (MBL-HCV1) combined with telaprevir \[part 1: an HCV protease inhibitor\] or sofosbuvir \[part 2: an Hepatitis C virus NS5B polymerase inhibitor\] in a 56 day treatment duration in patients undergoing liver transplantation due to chronic HCV infection. There is an option for extended study treatment through 84 days if viral load is undetectable at day 56.
Primary Outcome
The primary outcome was to determine if MBL-HCV1 in combination with the oral direct-acting antiviral could reduce HCV viral RNA to undetectable at day 56 post transplant and prevent the new liver from becoming productively infected. Undetectable HCV RNA was defined as the level below the lower limit of detection (LLOD) of an FDA-approved polymerase chain reaction (PCR) assay. HCV RNA was quantified by PCR (e.g., COBAS®AmpliPrep/ COBAS® TaqMan® HCV Test manufactured by Roche or equivalent) at ea
Interventions
- BIOLOGICAL MBL-HCV1
- DRUG Telaprevir (Part 1)
- DRUG Sofosbuvir (Part 2)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2012-11-21 |
| Est. Completion | 2015-08-27 |
| Phase | Phase 2 |
Why NCT01532908 stopped before completion
NCT01532908 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which MBL-HCV1 is the first listed.
NCT01532908 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01532908 about?
NCT01532908 is a clinical study titled "Open Label Study of the Efficacy and Safety of MBL-HCV1 in Combination With Oral Direct-Acting Antivirals in Patients Undergoing Liver Transplantation for Hepatitis C". The purpose of this study is to assess efficacy of a human monoclonal antibody against Hepatitis C (MBL-HCV1) combined with telaprevir \[part 1: an HCV protease inhibitor\] or sofosbuvir \[part 2: an Hepatitis C virus NS5B polymerase inhibitor\] in a 56 day treatment duration in patients undergoing ...
What is the current status of trial NCT01532908?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2012-11-21. Estimated completion is 2015-08-27.
What interventions are being tested in trial NCT01532908?
The interventions under investigation include: MBL-HCV1 (BIOLOGICAL), Telaprevir (Part 1) (DRUG), Sofosbuvir (Part 2) (DRUG).
Who is sponsoring clinical trial NCT01532908?
This trial is sponsored by MassBiologics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01532908's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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