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Completed Phase 3 Interventional Results available

TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy

ClinicalTrials.gov ID: NCT01485991

Public ClinicalTrials.gov record NCT01485991. 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 Nov 4, 2026, 4:52 AM EST

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Official title

Phase III in Partial and Null Responders

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to demonstrate the efficacy of TMC435 in combination with peginterferon (PegIFN) + ribavirin (RBV) by means of establishing its non- inferiority compared to an approved regimen of telaprevir + PegIFN + RBV in patients who have previously failed PegIFN.

Study identification

NCT ID
NCT01485991
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Janssen R&D Ireland
Industry
Enrollment
771 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
Feb 2012 (Type not available)
Primary completion
Apr 2014 (Actual)
Completion
Apr 2014 (Actual)
Last update posted
Apr 26, 2016

2012 – 2014

United States locations

U.S. sites
32
U.S. states
20
U.S. cities
32
Facility City State ZIP Site status
Not listed Bakersfield California — —
Not listed San Diego California — —
Not listed Aurora Colorado — —
Not listed Washington D.C. District of Columbia — —
Not listed Jacksonville Florida — —
Not listed Orlando Florida — —
Not listed West Palm Beach Florida — —
Not listed Atlanta Georgia — —
Not listed Honolulu Hawaii — —
Not listed Chicago Illinois — —
Not listed Crestview Hills Kentucky — —
Not listed New Orleans Louisiana — —
Not listed Chevy Chase Maryland — —
Not listed Jackson Mississippi — —
Not listed Tupelo Mississippi — —
Not listed Kansas City Missouri — —
Not listed Missoula Montana — —
Not listed Newark New Jersey — —
Not listed New York New York — —
Not listed Rochester New York — —
Not listed Cincinnati Ohio — —
Not listed Cleveland Ohio — —
Not listed Allentown Pennsylvania — —
Not listed Philadelphia Pennsylvania — —
Not listed Pittsburgh Pennsylvania — —
Not listed Arlington Texas — —
Not listed Houston Texas — —
Not listed Odessa Texas — —
Not listed San Antonio Texas — —
Not listed Falls Church Virginia — —
Not listed Bellevue Washington — —
Not listed Seattle Washington — —

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 105 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01485991, 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 26, 2016 · Synced Nov 4, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01485991 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →