An Efficacy, Safety and Tolerability Study of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous Therapy
Public ClinicalTrials.gov record NCT01281839. 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
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of TMC435 vs Placebo as Part of a Treatment Regimen Including Peginterferon α-2a and Ribavirin in Hepatitis C, Genotype 1 Infected Subjects Who Relapsed After Previous Interferon-based Therapy
Study identification
- NCT ID
- NCT01281839
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Janssen R&D Ireland
- Industry
- Enrollment
- 394 participants
Conditions and interventions
Conditions
Interventions
- TMC435 Drug
- Placebo Drug
- Peginterferon alpha-2a (PegIFN alpha-2a) Drug
- Ribavirin (RBV) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Jan 31, 2011
- Primary completion
- Jan 31, 2013
- Completion
- Jan 31, 2013
- Last update posted
- Apr 22, 2014
2011 – 2013
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Bakersfield | California | — | — |
| Not listed | Aurora | Colorado | — | — |
| Not listed | Jacksonville | Florida | — | — |
| Not listed | Orlando | Florida | — | — |
| Not listed | Atlanta | Georgia | — | — |
| Not listed | Crestview Hills | Kentucky | — | — |
| Not listed | Saint Paul | Minnesota | — | — |
| Not listed | Jackson | Mississippi | — | — |
| Not listed | Germantown | Tennessee | — | — |
| Not listed | Houston | Texas | — | — |
| Not listed | San Antonio | 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 57 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01281839, 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 Apr 22, 2014 · Synced Jun 25, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01281839 live on ClinicalTrials.gov.