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NCT00774397 · ClinicalTrials.gov registry record · Phase 2
Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 719
- Enrollment target
NCT00774397: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT00774397 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 719 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (441% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00774397, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 719 participants
- Enrollment target
Study Summary
The objective was to investigate the antiviral effect, safety, and pharmacokinetics of BI 201335 (Faldaprevir), given as a soft gelatine capsule, in patients with hepatitis C virus (HCV) genotype 1 infection. Combination therapy of BI 201335 (Faldaprevir) with pegylated interferon α-2a (PegIFN) and ribavirin (RBV), with or without a 3-day lead-in, was assessed in treatment-naïve (TN) and treatment experienced (TE) patients.
Primary Outcome
An achieved virological response is defined as the plasma Hepatitis C Virus RiboNucleic Acid (HCV RNA) level below the lower limit of detection (BLD). This data was only collected for patients, who stopped trial participation at Week 24 and did not continue with PegIFN/RBV until Week 48. The lower limit of quantification (BLQ) of this assay was 25 IU/mL and the lower limit of detection (BLD) was 10 IU/mL at the time of the protocol finalisation. During the course of the trial, the manufacturer
Interventions
- DRUG PegIFN/RBV
- DRUG BI 201335 NA 240 mg QD / LI
- DRUG BI 201335 NA 120mg QD / LI
- DRUG BI 201335 NA 240 mg QD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 719 participants |
| Start Date | 2008-10 |
| Phase | Phase 2 |
What the finished NCT00774397 record still lists
NCT00774397 is an interventional study that assigns participants to a tested intervention. The registered 719 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 (441% higher).
The record links to 0 conditions, and to 4 interventions - of which PegIFN/RBV is the first listed.
NCT00774397 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00774397 about?
NCT00774397 is a clinical study titled "Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)". The objective was to investigate the antiviral effect, safety, and pharmacokinetics of BI 201335 (Faldaprevir), given as a soft gelatine capsule, in patients with hepatitis C virus (HCV) genotype 1 infection. Combination therapy of BI 201335 (Faldaprevir) with pegylated interferon α-2a (PegIFN) and ...
What is the current status of trial NCT00774397?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 719 participants. The study started on 2008-10.
What interventions are being tested in trial NCT00774397?
The interventions under investigation include: PegIFN/RBV (DRUG), BI 201335 NA 240 mg QD / LI (DRUG), BI 201335 NA 120mg QD / LI (DRUG), BI 201335 NA 240 mg QD (DRUG).
Who is sponsoring clinical trial NCT00774397?
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 NCT00774397's enrollment target sits among peer trials
719 45th of 2000 higher than 1,956 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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