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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 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.

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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

Sponsor

Hoffmann-La Roche

909 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01628094

The ClinicalTrials.gov registry entry for NCT01628094 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 372-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (70% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.