A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment
Public ClinicalTrials.gov record NCT00980330. 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 IIb, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Efficacy, Tolerability, Safety and Pharmacokinetics of TMC435 as Part of a Treatment Regimen Including PegIFNa-2a and Ribavirin in HCV Genotype 1 Infected Subjects Who Failed Previous Standard Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine the efficacy, safety and tolerability of different regimens of TMC435 with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C virus (HCV) infection who has failed previous treatment with pegylated interferon (Peg-INF-alfa-2a) and ribavirin (RBV).
Study identification
- NCT ID
- NCT00980330
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 463 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 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
- Oct 2009 (Type not available)
- Primary completion
- Aug 2011 (Actual)
- Completion
- Aug 2011 (Actual)
- Last update posted
- Jun 9, 2014
2009 – 2011
United States locations
- U.S. sites
- 17
- U.S. states
- 11
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | La Jolla | California | — | — |
| Not listed | Los Angeles | California | — | — |
| Not listed | Jacksonville | Florida | — | — |
| Not listed | Miami | Florida | — | — |
| Not listed | Orlando | Florida | — | — |
| Not listed | Palm Harbor | Florida | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | New Orleans | Louisiana | — | — |
| Not listed | Laurel | Maryland | — | — |
| Not listed | Jackson | Mississippi | — | — |
| Not listed | Tupelo | Mississippi | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Chapel Hill | North Carolina | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Germantown | Tennessee | — | — |
| Not listed | Nashville | Tennessee | — | — |
| 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 61 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00980330, 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 9, 2014 · Synced Oct 17, 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 public registry record, listed eligibility criteria, and available contact information for NCT00980330 live on ClinicalTrials.gov.