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NCT01132313 · ClinicalTrials.gov registry record · Phase 2
Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 488
- Enrollment target
NCT01132313: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT01132313 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 488 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (267% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01132313, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 488 participants
- Enrollment target
Study Summary
The substances BI 201335 and BI 207127 are being developed for the treatment of chronic hepatitis C virus infection. BI 201335 and BI 207127 work by preventing the virus from replicating. The currently available medications pegylated interferon alfa and ribavirin for hepatitis C ca have considerable adverse events in patients and in many cases are not sufficiently effective. This is particularly the case in treatment of patients infected with genotype 1 of HCV. A combination therapy of these new substances without pegylated interferon alfa may be associated with fewer adverse events that currently available (pegylated interferon-alfa-based) medication and may also provide a treatment option to the large number of patients with contraindications or intolerance to pegylated interferon alfa. This clinical trial (1241.21) currently consists of 3 distinct studies: Part 1, Part 2 and Part 3. Part 1 (SOUND-C1) is a 2 armed study as described in experimental arms 1 and 2 below (actual enrollment: 56 patients; randomized and treated: 32) Part 2 (SOUND-C2) is a 5 armed study as described in experimental arms 3 to 7 below (actual enrollment: 465; randomized and treated: 362) Part 3 (SOUND-C3) includes 3 arms as described in experimental arms 8 to 10 below (83 patients randomized and treated)
Primary Outcome
Part 1: Rapid virological response (RVR), defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) \<25IU/mL at Week 4 of treatment
Interventions
- DRUG Ribavirin
- DRUG BI 201335
- DRUG BI 207127
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 488 participants |
| Start Date | 2010-05 |
| Est. Completion | 2014-10 |
| Phase | Phase 2 |
What the finished NCT01132313 record still lists
NCT01132313 is an interventional study that assigns participants to a tested intervention. The registered 488 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (267% higher).
The record links to 0 conditions, and to 3 interventions - of which Ribavirin is the first listed.
NCT01132313 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01132313 about?
NCT01132313 is a clinical study titled "Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection". The substances BI 201335 and BI 207127 are being developed for the treatment of chronic hepatitis C virus infection. BI 201335 and BI 207127 work by preventing the virus from replicating. The currently available medications pegylated interferon alfa and ribavirin for hepatitis C ca have considerabl...
What is the current status of trial NCT01132313?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 488 participants. The study started on 2010-05. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01132313?
The interventions under investigation include: Ribavirin (DRUG), BI 201335 (DRUG), BI 207127 (DRUG).
Who is sponsoring clinical trial NCT01132313?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01132313's enrollment target sits among peer trials
488 76th of 2000 higher than 1,925 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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