Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)
Public ClinicalTrials.gov record NCT00774397. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Antiviral Effect, Safety and Pharmacokinetics of BI 201335 NA in Hepatitis C Virus Genotype 1 Infected Treatment-naïve and Treatment-experienced Patients for 24 Weeks as Combination Therapy With Pegylated Interferon-alpha 2a and Ribavirin (Double-blinded, Randomised, Placebo-controlled, Phase II)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00774397
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 719 participants
Conditions and interventions
Conditions
Interventions
- BI 201335 NA 240 mg QD / LI Drug
- PegIFN/RBV Drug
- BI 201335 NA 120mg QD / LI Drug
- BI 201335 NA 240 mg QD Drug
- BI 201335 NA 240 mg BID Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2008 (Type not available)
- Primary completion
- Nov 2011 (Actual)
- Completion
- Not listed
- Last update posted
- Nov 16, 2015
Started 2008
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1220.5.0001 Boehringer Ingelheim Investigational Site | San Francisco | California | — | — |
| 1220.5.0008 Boehringer Ingelheim Investigational Site | San Francisco | California | — | — |
| 1220.5.0005 Boehringer Ingelheim Investigational Site | Chicago | Illinois | — | — |
| 1220.5.0006 Boehringer Ingelheim Investigational Site | Lutherville | Maryland | — | — |
| 1220.5.0002 Boehringer Ingelheim Investigational Site | New York | New York | — | — |
| 1220.5.0003 Boehringer Ingelheim Investigational Site | New York | New York | — | — |
| 1220.5.0007 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | — | — |
| 1220.5.0010 Boehringer Ingelheim Investigational Site | Germantown | Tennessee | — | — |
| 1220.5.0009 Boehringer Ingelheim Investigational Site | Nashville | Tennessee | — | — |
| 1220.5.0004 Boehringer Ingelheim Investigational Site | Austin | Texas | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 90 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00774397, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 16, 2015 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00774397 live on ClinicalTrials.gov.