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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis C, Chronic | Drug: RO5024048 Drug: danoprevir | Phase 1 |
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 |
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
|
- HCV RNA [ Time Frame: At each clinic visit, throughout study ]
- Adverse events, laboratory parameters, vital signs [ Time Frame: At each clinic visit, throughout study ]
- PK parameters;viral resistance [ Time Frame: At intervals, throughout study ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Australia | |
Adelaide, Australia, SA 5000 | |
Heidelberg, Australia, 3084 | |
Melbourne, Australia, 3181 | |
New Zealand | |
Christchurch, New Zealand, 8011 | |
Grafton, New Zealand, 1150 |
Study Director: | Clinical Trials | Hoffmann-La Roche |
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 |