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Hepatitis C, ChronicPhase 2NCT01628094

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 testing RO5024048, RO5190591 and RO5466731 in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 31 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
RO5024048, RO5190591 and RO5466731
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
31 sitesin 5 countries
Study dates
Jun 2012to Nov 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients, >/= 18 years of age
  • Chronic hepatitis C genotype 1 of >/= 6 months duration at screening
  • Part 1 and Part 2: Naïve to treatment with interferon (pegylated or non-pegylated). Patients who have participated in studies investigating a direct-acting antiviral agent with or without interferon are excluded
  • Part 2: Treatment experienced patients having a previous null response to treatment with interferon containing regimen
  • Liver biopsy or non-invasive (e.g. Fibroscan) evaluation in the past 24 calendar months showing absence of cirrhosis or incomplete/transition to cirrhosis
  • Body mass index (BMI) 18 to 35 kg/m2 inclusive and body weight >/= 45 kg

Who cannot join

  • Pregnant or lactating women or males with female partners who are pregnant or lactating
  • Decompensated liver disease or impaired liver function (as defined by protocol)
  • Cirrhosis or incomplete/transition to cirrhosis
  • Non- hepatitis C chronic liver disease
  • Positive for hepatitis B or HIV infection
  • History of pre-existing renal disease
Show all 13Show fewer
  • History of severe cardiac disease
  • History of neoplastic disease within the last 5 years, except for localized or in situ carcinoma of the skin
  • History of drug abuse within the last year; history of cannabinoid use is not excluded
  • Evidence of alcohol abuse within 1 year of screening and consumption of more than 2 units of alcohol per day
  • Medical condition that requires use of systemic corticosteroids
  • Received warfarin or other anticoagulants during the 21 days immediately prior to screening or is expected to require warfarin or other anticoagulants during the study
  • Anticipated use or need for significant medical treatment during the study or use of concomitant medications or nutrients that are excluded by protocol (e.g. drugs that are contraindicated with ritonavir, hormonal methods of contraception)

Trial locations and contacts

31 sites in 5 countries.

31 sites in 5 countries

United States15 sites

  • Study site

    Asheville, North Carolina, 28801

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Dallas, Texas, 75246

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Englewood, Colorado, 80113

  • Study site

    Honolulu, Hawaii, 96813

  • Study site

    Houston, Texas, 77030

  • Study site

    Kansas City, Kansas, 66160

  • Study site

    La Jolla, California, 92037

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Saint Louise, Missouri, 63104

  • Study site

    San Antonio, Texas, 78215

  • Study site

    San Antonio, Texas, 78234

  • Study site

    South Miami, Florida, 33143

  • Study site

    Vancouver, Washington, 98664

Other trials in United States

Australia5 sites

  • Study site

    Herston, Queensland, 4029

  • Study site

    Kingswood, New South Wales

  • Study site

    Parkville, Victoria, 3052

  • Study site

    Sydney, New South Wales, 2050

  • Study site

    Westmead, New South Wales, 2145

Other trials in Australia

Germany4 sites

  • Study site

    Berlin, 13353

  • Study site

    Frankfurt am Main, 60590

  • Study site

    Hamburg, 20099

  • Study site

    Hanover, 30625

Other trials in Germany

Poland4 sites

  • Study site

    Bialystok, 15-540

  • Study site

    Chorzów, 41-500

  • Study site

    Lodz, 91-357

  • Study site

    Mysłowice, 41-400

Other trials in Poland

New Zealand3 sites

  • Study site

    Dunedin, 9016

  • Study site

    Grafton, 1010

  • Study site

    Hamilton

Other trials in New Zealand

About this study

Official title: Randomized, Open-Label, Multicenter Study of Safety, Efficacy, and Tolerability of the Combination of RO5466731, RO5190591, Ritonavir, and Copegus With or Without RO5024048 in HCV Genotype 1 Infected Patients Who Are Either Treatment Naïve or Null Responders to Previous 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 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.

Being tested
RO5024048, RO5190591, RO5466731, ribavirin [Copegus], ritonavir
Medical subject headings
Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RO5024048Drug

  • RO5190591Drug

  • RO5466731Drug

  • ribavirin [Copegus]Drug

  • ritonavirDrug

Study groups in NCT01628094
Study groupRoleWhat they receive
A: GT1a 3DAAExperimentalincluding RO5466731, RO5190591, ritonavir, ribavirin [Copegus] and RO5024048
Receives: Drug: RO5024048; Drug: RO5190591; Drug: RO5466731; Drug: ribavirin [Copegus]; Drug: ritonavir
B: GT1a 3DAAExperimentalincluding RO5466731, RO5190591, ritonavir, ribavirin [Copegus] and RO5024048
Receives: Drug: RO5024048; Drug: RO5190591; Drug: RO5466731; Drug: ribavirin [Copegus]; Drug: ritonavir
C: GT1a 2DAAExperimentalincluding RO5466731, RO5190591, ritonavir and ribavirin [Copegus]
Receives: Drug: RO5190591; Drug: RO5466731; Drug: ribavirin [Copegus]; Drug: ritonavir
D: GT1b 3DAAExperimentalincluding RO5466731, RO5190591, ritonavir, ribavirin [Copegus] and RO5024048
Receives: Drug: RO5024048; Drug: RO5190591; Drug: RO5466731; Drug: ribavirin [Copegus]; Drug: ritonavir
E: GT1b 2DAAExperimentalincluding RO54664731, RO5190591, ritonavir and ribavirin [Copegus]
Receives: Drug: RO5190591; Drug: RO5466731; Drug: ribavirin [Copegus]; Drug: ritonavir
Part IIExperimentalNot described
Receives: Drug: RO5024048; Drug: RO5190591; Drug: RO5466731; Drug: ribavirin [Copegus]; Drug: ritonavir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sustained virological response (defined as undetectable serum HCV RNA) 12 weeks after end of treatment

    Measured: approximately 20 months

  2. Safety: Incidence of adverse events

    Measured: approximately 20 months

Secondary outcomes (4)

  1. Antiviral activity: Change in serum HCV RNA levels

    Measured: from baseline to 24 weeks after end of treatment

  2. Pharmacokinetics in coadministration: Area under the concentration-time curve (AUC)

    Measured: Pre-dose Weeks 1, 2, 3, 4, 6, 10, and 12 and up to 12 hours post-dose Weeks 1, and 4 or 3 and 6

  3. HCV drug resistance

    Measured: approximately 20 months

  4. Quality of life: Short-Form 36v2/Brief Fatigue Inventory questionnaires

    Measured: approximately 20 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionNov 2013
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01628094
Sponsor's protocol ID
NP28266
Other IDs
2012-000638-21
Status last verified
Nov 2016
First submitted
22 Jun 2012
Last updated
2 Nov 2016
Results posted
No

Publications

  • Jensen DM, Brunda M, Elston R, Gane EJ, George J, Glavini K, Hammond JM, Le Pogam S, Najera I, Passe S, Piekarska A, Rodriguez I, Zeuzem S, Chu T; ANNAPURNA study investigators. Interferon-free regimens containing setrobuvir for patients with genotype 1 chronic hepatitis C: a randomized, multicenter study. Liver Int. 2016 Apr;36(4):505-14. doi: 10.1111/liv.12997. Epub 2015 Dec 12.

    PubMed 26519669

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RO5024048, RO5190591 and RO5466731 in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 31 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Australia, Germany, Poland, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sustained virological response (defined as undetectable serum HCV RNA) 12 weeks after end of treatment (time frame: approximately 20 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01628094, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

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