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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

NCT ID: NCT00801255

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis C, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort A

Group Type EXPERIMENTAL

RO5024048

Intervention Type DRUG

500mg po bid/100mg po q8h for 7 days

Cohort B

Group Type EXPERIMENTAL

danoprevir

Intervention Type DRUG

500mg po bid/100mg po q8h for 14 days

Cohort C

Group Type EXPERIMENTAL

danoprevir

Intervention Type DRUG

1000mg po bid/100mg po q8h for 14 days\\n500mg po bid/200mg po q8h for 14 days

Cohort D

Group Type EXPERIMENTAL

danoprevir

Intervention Type DRUG

1000mg po bid/200mg po q8h for 14 days

Cohort E

Group Type EXPERIMENTAL

danoprevir

Intervention Type DRUG

1000mg/600mg po twice daily for 14 days

Cohort F

Group Type EXPERIMENTAL

danoprevir

Intervention Type DRUG

1000mg/900mg po twice daily for 14 days

Cohort G

Group Type EXPERIMENTAL

danoprevir

Intervention Type DRUG

1000mg/900mg po twice daily for 14 days

Interventions

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RO5024048

500mg po bid/100mg po q8h for 7 days

Intervention Type DRUG

danoprevir

500mg po bid/100mg po q8h for 14 days

Intervention Type DRUG

danoprevir

1000mg po bid/100mg po q8h for 14 days\\n500mg po bid/200mg po q8h for 14 days

Intervention Type DRUG

danoprevir

1000mg po bid/200mg po q8h for 14 days

Intervention Type DRUG

danoprevir

1000mg/600mg po twice daily for 14 days

Intervention Type DRUG

danoprevir

1000mg/900mg po twice daily for 14 days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Adelaide, , Australia

Site Status

Heidelberg, , Australia

Site Status

Melbourne, , Australia

Site Status

Christchurch, , New Zealand

Site Status

Grafton, , New Zealand

Site Status

Countries

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Australia New Zealand

References

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Gane EJ, Roberts SK, Stedman CA, Angus PW, Ritchie B, Elston R, Ipe D, Morcos PN, Baher L, Najera I, Chu T, Lopatin U, Berrey MM, Bradford W, Laughlin M, Shulman NS, Smith PF. Oral combination therapy with a nucleoside polymerase inhibitor (RG7128) and danoprevir for chronic hepatitis C genotype 1 infection (INFORM-1): a randomised, double-blind, placebo-controlled, dose-escalation trial. Lancet. 2010 Oct 30;376(9751):1467-75. doi: 10.1016/S0140-6736(10)61384-0. Epub 2010 Oct 14.

Reference Type DERIVED
PMID: 20951424 (View on PubMed)

Other Identifiers

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PP22205

Identifier Type: -

Identifier Source: org_study_id