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NCT00984620 · ClinicalTrials.gov registry record · Phase 2
Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
NCT00984620: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT00984620 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 160 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00984620, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
Study Summary
To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with hepatitis C virus (HCV) genotype 1
Primary Outcome
Virological response at Week 28: The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at Week 28.
Interventions
- DRUG Ribavirin (RBV)
- DRUG BI 201335
- DRUG Pegylated Interferon-alpha (IFN)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2009-09 |
| Phase | Phase 2 |
What the finished NCT00984620 record still lists
NCT00984620 is an interventional study that assigns participants to a tested intervention. The registered 160 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 (20% higher).
The record links to 0 conditions, and to 3 interventions - of which Ribavirin (RBV) is the first listed.
NCT00984620 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00984620 about?
NCT00984620 is a clinical study titled "Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)". To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with hepatitis C virus (HCV) genotype 1
What is the current status of trial NCT00984620?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2009-09.
What interventions are being tested in trial NCT00984620?
The interventions under investigation include: Ribavirin (RBV) (DRUG), BI 201335 (DRUG), Pegylated Interferon-alpha (IFN) (DRUG).
Who is sponsoring clinical trial NCT00984620?
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 NCT00984620's enrollment target sits among peer trials
160 422nd of 2000 higher than 1,559 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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