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

> **NCT00774397** · PHASE2 · COMPLETED · sponsor: **Boehringer Ingelheim** · enrollment: 719 (actual)

## Conditions studied

- Hepatitis C, Chronic

## Interventions

- **DRUG:** BI 201335 NA 240 mg QD / LI
- **DRUG:** PegIFN/RBV
- **DRUG:** BI 201335 NA 120mg QD / LI
- **DRUG:** PegIFN/RBV
- **DRUG:** BI 201335 NA 240 mg QD
- **DRUG:** PegIFN/RBV
- **DRUG:** BI 201335 NA 240 mg QD
- **DRUG:** PegIFN/RBV
- **DRUG:** BI 201335 NA 240 mg BID
- **DRUG:** PegIFN/RBV
- **DRUG:** PegIFN/RBV
- **DRUG:** BI 201335 NA 240 mg QD
- **DRUG:** PegIFN/RBV
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT00774397
- **Lead sponsor:** Boehringer Ingelheim
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2008-10
- **Primary completion:** 2011-11
- **Final completion:** —
- **Target enrollment:** 719 (ACTUAL)
- **Last updated:** 2015-11-16


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00774397

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00774397, "Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)". Retrieved via AI Analytics 2026-06-09 from https://api.ai-analytics.org/clinical/NCT00774397. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*