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NCT01628094 · ClinicalTrials.gov registry record · Phase 2

ANNAPURNA: A Study of The Combination of RO5466731, RO5190591, Ritonavir and Copegus (Ribavirin) With or Without RO5024048 in Patients With Chronic Hepatitis C Who Are Either Treatment-Naïve or Have Previously Experienced a Null Response to Interferon-Based Treatment

A Phase 2 study of Hepatitis C, Chronic, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 2
Development phase
110
Enrollment target
20
Study locations

NCT01628094: Completed Phase 2 study of Hepatitis C, Chronic, sponsored by Hoffmann-La Roche.

NCT01628094 is a Phase 2 study of Hepatitis C, Chronic that has completed, run by Hoffmann-La Roche. The registered enrollment target is 110 participants, below the 372-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01628094, a Phase 2 study of Hepatitis C, Chronic, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 2
Development phase
110 participants
Enrollment target
20
Study locations

Study Summary

This randomized, open-label, multicenter study will evaluate the safety , efficacy and tolerability of the combination treatment RO5466731, RO5190591, ritonavir and Copegus (ribavirin) with or without RO5024048 in patients with chronic hepatitis C genotype 1. In Part 1, treatment-naïve patients will be randomized to receive treatment with RO5466731, RO5190591 plus ritonavir, and Copegus, with or without RO5024048. In Part 2, further treatment-naïve patients will receive a successful regimen from Part 1, or a reduced intensity regimen, and patients who have previously experienced null response to interferon-based treatment will be added to the study.

Conditions Studied

Hepatitis C, Chronic

Interventions

  • DRUG ritonavir
  • DRUG RO5024048
  • DRUG RO5190591
  • DRUG RO5466731
  • DRUG ribavirin [Copegus]

Study Locations (20)

Texas

  • - Dallas
  • - Houston
  • - San Antonio
  • - San Antonio

New South Wales

  • - Kingswood
  • - Sydney
  • - Westmead

California

  • - La Jolla

Colorado

  • - Englewood

Florida

  • - South Miami

Georgia

  • - Marietta

Hawaii

  • - Honolulu

Illinois

  • - Chicago

Trial Details

FieldValue
Enrollment Target 110 participants
Start Date 2012-06
Est. Completion 2013-11
Phase Phase 2
Hoffmann-La Roche

909 total trials

What the finished NCT01628094 record still lists

NCT01628094 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 372-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (70% lower).

The record links to 1 condition, with Hepatitis C, Chronic appearing as the primary indexed condition, and to 5 interventions - of which ritonavir is the first listed.

NCT01628094 names 20 study sites across 15 states, led by Texas, New South Wales, California.

Frequently Asked Questions

What is clinical trial NCT01628094 about?

NCT01628094 is a clinical study titled "ANNAPURNA: A Study of The Combination of RO5466731, RO5190591, Ritonavir and Copegus (Ribavirin) With or Without RO5024048 in Patients With Chronic Hepatitis C Who Are Either Treatment-Naïve or Have Previously Experienced a Null Response to Interferon-Based Treatment". This randomized, open-label, multicenter study will evaluate the safety , efficacy and tolerability of the combination treatment RO5466731, RO5190591, ritonavir and Copegus (ribavirin) with or without RO5024048 in patients with chronic hepatitis C genotype 1. In Part 1, treatment-naïve patients will...

What is the current status of trial NCT01628094?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2012-06. Estimated completion is 2013-11.

What conditions does trial NCT01628094 study?

This clinical trial studies the following conditions: Hepatitis C, Chronic.

What interventions are being tested in trial NCT01628094?

The interventions under investigation include: ritonavir (DRUG), RO5024048 (DRUG), RO5190591 (DRUG), RO5466731 (DRUG), ribavirin [Copegus] (DRUG).

Who is sponsoring clinical trial NCT01628094?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01628094 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Georgia, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Hepatitis C, Chronic

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01628094's enrollment target sits among peer trials

110 15th of 26 higher than 12 of 26 other Hepatitis C, Chronic trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hepatitis C, Chronic 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 NCT01628094, the US trial registry maintained by the National Library of Medicine. NCT01628094 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.