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NCT01479868 · ClinicalTrials.gov registry record · Phase 3

A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1

A Phase 3 study of Hepatitis C Virus Genotype-1, sponsored by Janssen R&D Ireland.

Completed
Registry status
Phase 3
Development phase
109
Enrollment target
20
Study locations

NCT01479868: Completed Phase 3 study of Hepatitis C Virus Genotype-1, sponsored by Janssen R&D Ireland.

NCT01479868 is a Phase 3 study of Hepatitis C Virus Genotype-1 that has completed, run by Janssen R&D Ireland. The registered enrollment target is 109 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01479868, a Phase 3 study of Hepatitis C Virus Genotype-1, has completed, sponsored by Janssen R&D Ireland.

COMPLETED
Registry status
Phase 3
Development phase
109 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the safety and tolerability of TMC435 along with pegylated interferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) triple therapy in hepatitis C virus genotype-1 infected subjects, co-infected with human immunodeficiency virus-type 1, and to evaluate the number of patients with sustained virologic response (SVR) at 12 weeks after the planned end of treatment.

Primary Outcome

The SVR 12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (\<) 25 international unit per milliliter (IU/mL) undetectable at the actual end of treatment (EOT), and HCV RNA levels \<25 IU/mL undetectable or HCV RNA levels \<25 IU/mL detectable at 12 Weeks after end of treatment.

Conditions Studied

Hepatitis C Virus Genotype-1

Interventions

  • DRUG Ribavirin
  • DRUG TMC435
  • DRUG Pegylated interferon alpha-2a

Study Locations (20)

Other

  • - Lyon
  • - Montpellier
  • - Nantes
  • - Paris
  • - Berlin
  • - Bonn
  • - Cologne
  • - Düsseldorf

New York

  • - Albany
  • - New York

Texas

  • - Dallas
  • - Houston

California

  • - Los Angeles

District of Columbia

  • - Washington D.C.

Florida

  • - Orlando

Georgia

  • - Atlanta

Illinois

  • - Chicago

Trial Details

FieldValue
Enrollment Target 109 participants
Start Date 2011-10
Est. Completion 2013-08
Phase Phase 3
Janssen R&D Ireland

14 total trials

What the finished NCT01479868 record still lists

NCT01479868 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).

The record links to 1 condition, with Hepatitis C Virus Genotype-1 appearing as the primary indexed condition, and to 3 interventions - of which Ribavirin is the first listed.

NCT01479868 names 20 study sites across 11 states, led by Other, New York, Texas.

Frequently Asked Questions

What is clinical trial NCT01479868 about?

NCT01479868 is a clinical study titled "A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1". The purpose of this study is to evaluate the safety and tolerability of TMC435 along with pegylated interferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) triple therapy in hepatitis C virus genotype-1 infected subjects, co-infected with human immunodeficiency virus-type 1, and to evaluate the number ...

What is the current status of trial NCT01479868?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 109 participants. The study started on 2011-10. Estimated completion is 2013-08.

What conditions does trial NCT01479868 study?

This clinical trial studies the following conditions: Hepatitis C Virus Genotype-1.

What interventions are being tested in trial NCT01479868?

The interventions under investigation include: Ribavirin (DRUG), TMC435 (DRUG), Pegylated interferon alpha-2a (DRUG).

Who is sponsoring clinical trial NCT01479868?

This trial is sponsored by Janssen R&D Ireland, which has 14 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01479868 being conducted?

This trial has 20 study locations across California, District of Columbia, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

How this trial's enrollment target compares

Where NCT01479868's enrollment target sits among peer trials

109 1664th of 2000 higher than 337 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01479868, the US trial registry maintained by the National Library of Medicine. NCT01479868 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.