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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT00801255

Collaborator

(none)

Enrollment

Locations

Arms

15.9

Duration (Months)

17.6

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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 Drug: danoprevir Drug: danoprevir Drug: danoprevir Drug: danoprevir	Phase 1

Study Design

Study Type:

Interventional

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 :

Nov 1, 2008

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

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

Primary Outcome Measures

HCV RNA [At each clinic visit, throughout study]
Adverse events, laboratory parameters, vital signs [At each clinic visit, throughout study]

Secondary Outcome Measures

PK parameters;viral resistance [At intervals, throughout study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	Country	Postal Code
1	Adelaide	Australia	SA 5000
2	Heidelberg	Australia	3084
3	Melbourne	Australia	3181
4	Christchurch	New Zealand	8011
5	Grafton	New Zealand	1150

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00801255

Other Study ID Numbers:

PP22205

First Posted:

Dec 3, 2008

Last Update Posted:

Nov 2, 2016

Last Verified:

Nov 1, 2016

Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 2, 2016