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Completed Phase 2 Interventional Results available

A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment

ClinicalTrials.gov ID: NCT00980330

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.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 3:53 AM EDT

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

Interventions

Drug

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
Sep 30, 2009
Primary completion
Jul 31, 2011
Completion
Jul 31, 2011
Last update posted
Jun 8, 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 8, 2014 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00980330 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →