An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients
Public ClinicalTrials.gov record NCT01289782. 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 Treatment-naïve, Genotype 1 Hepatitis Cinfected Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before. Participants will also receive peginterferon alpha-2a and ribavirin as part of their treatment.
Study identification
- NCT ID
- NCT01289782
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 395 participants
Conditions and interventions
Conditions
Interventions
- Placebo Drug
- TMC435 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
- Feb 2011 (Type not available)
- Primary completion
- Jan 2013 (Actual)
- Completion
- Jan 2013 (Actual)
- Last update posted
- Jun 4, 2014
2011 – 2013
United States locations
- U.S. sites
- 22
- U.S. states
- 14
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Dothan | Alabama | — | — |
| Not listed | Hoover | Alabama | — | — |
| Not listed | Phoenix | Arizona | — | — |
| Not listed | Bakersfield | California | — | — |
| Not listed | Coronado | California | — | — |
| Not listed | Long Beach | California | — | — |
| Not listed | San Diego | California | — | — |
| Not listed | Aurora | Colorado | — | — |
| Not listed | Englewood | Colorado | — | — |
| Not listed | Miami | Florida | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Jackson | Mississippi | — | — |
| Not listed | Tupelo | Mississippi | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Chapel Hill | North Carolina | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Nashville | Tennessee | — | — |
| Not listed | Dallas | Texas | — | — |
| 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 40 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01289782, 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 Jun 4, 2014 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01289782 live on ClinicalTrials.gov.