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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 study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01628094
First received: June 22, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Hepatitis C, Chronic
 Drug: RO5466731
Drug: RO5190591
Drug: ritonavir
Drug: ribavirin [Copegus]
Drug: RO5024048
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Sustained virological response (defined as undetectable serum HCV RNA) 12 weeks after end of treatment [ Time Frame: approximately 20 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 20 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Antiviral activity: Change in serum HCV RNA levels [ Time Frame: from baseline to 24 weeks after end of treatment ] [ Designated as safety issue: No ]
  • Pharmacokinetics in coadministration: Area under the concentration-time curve (AUC) [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • HCV drug resistance [ Time Frame: approximately 20 months ] [ Designated as safety issue: No ]
  • Quality of life: Short-Form 36v2/Brief Fatigue Inventory questionnaires [ Time Frame: approximately 20 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: June 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: GT1a 3DAA
including RO5466731, RO5190591, ritonavir, ribavirin [Copegus] and RO5024048
 Drug: RO5466731 Drug: RO5190591 Drug: ritonavir Drug: ribavirin [Copegus] Drug: RO5024048
Experimental: B: GT1a 3DAA
including RO5466731, RO5190591, ritonavir, ribavirin [Copegus] and RO5024048
 Drug: RO5466731 Drug: RO5190591 Drug: ritonavir Drug: ribavirin [Copegus] Drug: RO5024048
Experimental: C: GT1a 2DAA
including RO5466731, RO5190591, ritonavir and ribavirin [Copegus]
 Drug: RO5466731 Drug: RO5190591 Drug: ritonavir Drug: ribavirin [Copegus]
Experimental: D: GT1b 3DAA
including RO5466731, RO5190591, ritonavir, ribavirin [Copegus] and RO5024048
 Drug: RO5466731 Drug: RO5190591 Drug: ritonavir Drug: ribavirin [Copegus] Drug: RO5024048
Experimental: E: GT1b 2DAA
including RO54664731, RO5190591, ritonavir and ribavirin [Copegus]
 Drug: RO5466731 Drug: RO5190591 Drug: ritonavir Drug: ribavirin [Copegus]
Experimental: Part II Drug: RO5466731 Drug: RO5190591 Drug: ritonavir Drug: ribavirin [Copegus] Drug: RO5024048

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628094

Contacts
Contact: Please reference Study ID Number: NP28266 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Show 32 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01628094     History of Changes
Other Study ID Numbers: NP28266, 2012-000638-21
Study First Received: June 22, 2012
Last Updated: May 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Interferons
 Ribavirin
Ritonavir
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on May 22, 2013