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COMPLETED 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

NCT01628094 · View on ClinicalTrials.gov ↗

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

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

758 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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01628094 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Texas, New South Wales, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01628094?

The interventions under investigation include: ritonavir (DRUG), RO5024048 (DRUG), RO5190591 (DRUG), RO5466731 (DRUG), ribavirin [Copegus] (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01628094?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial