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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

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ClinicalTrials.gov Identifier: NCT00801255
Recruitment Status : Completed
First Posted : December 3, 2008
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: RO5024048 Drug: danoprevir Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. HCV RNA [ Time Frame: At each clinic visit, throughout study ]
  2. Adverse events, laboratory parameters, vital signs [ Time Frame: At each clinic visit, throughout study ]

Secondary Outcome Measures :
  1. PK parameters;viral resistance [ Time Frame: At intervals, throughout study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: December 3, 2008    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Flaviviridae Infections
Protease Inhibitors
HIV Protease Inhibitors
Lactams
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-Bacterial Agents