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Completed Phase 2 Interventional Results available

Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)

ClinicalTrials.gov ID: NCT00774397

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.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 9:18 AM EDT

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)

Study identification

NCT ID
NCT00774397
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
719 participants

Conditions and interventions

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
Sep 30, 2008
Primary completion
Oct 31, 2011
Completion
Not listed
Last update posted
Nov 15, 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 15, 2015 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00774397 live on ClinicalTrials.gov.

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