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A Study of Combination Treatment With an HCV Polymerase Inhibitor (RO5024048) and an HCV Protease Inhibitor (RO5190591/Danoprevir) in Genotype 1 Chronic Hepatitis C Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00801255
First received: December 2, 2008
Last updated: March 2, 2015
Last verified: March 2015
History of Changes
  Purpose

This 7 cohort study will evaluate the efficacy and safety of combination treatment with an HCV nucleoside polymerase inhibitor(RO5024048)and an HCV protease inhibitor(RO5190591/ITMN-191/danoprevir) in patients with chronic hepatitis C, genotype 1.Cohorts A,B,C,D and G will be treatment-naive patients, cohort E will be treatment-experienced excluding null responders, and cohort F will be null responders. Cohorts A and B will evaluate doses of 500mg po bid RO5024048 and 100mg po q8h RO5190591, alone or in combination, for up to 7 or 14 days. Cohort C will evaluate combination treatment with either 1000mg po bid RO5024048 and 100mg q8h RO5190591 or 500mg po bid RO5024048 and 200mg q8h RO5190591 for 14 days. Cohort D will evaluate 1000mg po bid RO5024048 and 200mg q8h RO5190591 for 14 days.Cohort E will evaluate 1000mg RO5024048/600mg RO5190591 po twice daily for 14 days, and Cohorts F and G will evaluate 1000mg RO5024048/900mg RO5190591 po twice daily for 14 days. Cohorts will be tested sequentially or in parallel, if supported by appropriate safety and pharmacokinetic data.Following the last dose of study medication patients have the option of continuing treatment with Standard of care therapies. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.


Condition Intervention Phase
Hepatitis C, Chronic
 Drug: RO5024048
Drug: danoprevir
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Dose-ranging Study to Evaluate the Safety, Tolerability and Antiviral Activity of Combination Treatment With an HCV Polymerase Inhibitor (RO5024048) and an HCV Protease Inhibitor (RO5190591) in Genotype 1 Chronic Hepatitis C Patients. INFORM 1

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • HCV RNA [ Time Frame: At each clinic visit, throughout study ] [ Designated as safety issue: No ]
  • Adverse events, laboratory parameters, vital signs [ Time Frame: At each clinic visit, throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PK parameters;viral resistance [ Time Frame: At intervals, throughout study ] [ Designated as safety issue: No ]
Enrollment: 88
Study Start Date: November 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort A Drug: RO5024048
500mg po bid/100mg po q8h for 7 days
Experimental: Cohort B Drug: danoprevir
500mg po bid/100mg po q8h for 14 days
Experimental: Cohort C Drug: danoprevir
1000mg po bid/100mg po q8h for 14 days\n500mg po bid/200mg po q8h for 14 days
Experimental: Cohort D Drug: danoprevir
1000mg po bid/200mg po q8h for 14 days
Experimental: Cohort E Drug: danoprevir
1000mg/600mg po twice daily for 14 days
Experimental: Cohort F Drug: danoprevir
1000mg/900mg po twice daily for 14 days
Experimental: Cohort G Drug: danoprevir
1000mg/900mg po twice daily for 14 days

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, 18-65 years of age;
  • chronic hepatitis C, genotype 1.

Exclusion Criteria:

  • decompensated liver disease, or impaired liver function;
  • presence or history of non-hepatitis C chronic liver disease;
  • HBsAg or HIV infection;
  • history of cancer within 5 years, other than localized or in situ cancer of the skin.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801255

Locations
Australia
Adelaide, Australia, SA 5000
Heidelberg, Australia, 3084
Melbourne, Australia, 3181
New Zealand
Christchurch, New Zealand, 8011
Grafton, New Zealand, 1150
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00801255     History of Changes
Other Study ID Numbers: PP22205
Study First Received: December 2, 2008
Last Updated: March 2, 2015
Health Authority: New Zealand: Health Research Council

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

ClinicalTrials.gov processed this record on March 03, 2015