# An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants

> **NCT01290679** · PHASE3 · COMPLETED · sponsor: **Janssen R&D Ireland** · enrollment: 393 (actual)

## Conditions studied

- Hepatitis C

## Interventions

- **DRUG:** Placebo
- **DRUG:** TMC435
- **DRUG:** Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b)
- **DRUG:** Ribavirin (RBV)

## Key facts

- **NCT ID:** NCT01290679
- **Lead sponsor:** Janssen R&D Ireland
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2011-03
- **Primary completion:** 2013-02
- **Final completion:** 2013-02
- **Target enrollment:** 393 (ACTUAL)
- **Last updated:** 2014-06-13


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01290679

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01290679, "An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT01290679. Licensed CC0.

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