A Study of Combination Treatment With an HCV Polymerase Inhibitor (RO5024048) and an HCV Protease Inhibitor (RO5190591) in Genotype 1 Chronic Hepatitis C Patients - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00801255

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) 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/RO5190591	Phase I

MedlinePlus related topics: Hepatitis Hepatitis C

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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.

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 ]

Estimated Enrollment:	64
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2009

Arms	Assigned Interventions
Cohort A: Experimental	Drug: RO5024048/RO5190591 500mg po bid/100mg po q8h for 7 days
Cohort B: Experimental	Drug: RO5024048/RO5190591 500mg po bid/100mg po q8h for 14 days
Cohort C: Experimental	Drug: RO5024048/RO5190591 1000mg po bid/100mg po q8h for 14 days 500mg po bid/200mg po q8h for 14 days
Cohort D: Experimental	Drug: RO5024048/RO5190591 1000mg po bid/200mg po q8h for 14 days
Cohort E: Experimental	Drug: RO5024048/RO5190591 1000mg/600mg po twice daily for 14 days
Cohort F: Experimental	Drug: RO5024048/RO5190591 1000mg/900mg po twice daily for 14 days
Cohort G: Experimental	Drug: RO5024048/RO5190591 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

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

Contacts

Contact: Please reference Study ID Number: PP22205	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

Australia
	Recruiting
MELBOURNE, Australia, 3181
	Recruiting
HEIDELBERG, Australia, 3084
	Recruiting
ADELAIDE, Australia, SA 5000
New Zealand
	Recruiting
AUCKLAND, New Zealand, 1150
	Recruiting
CHRISTCHURCH, New Zealand

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	PP22205
Study First Received:	December 2, 2008
Last Updated:	April 20, 2009
ClinicalTrials.gov Identifier:	NCT00801255 History of Changes
Health Authority:	New Zealand: Health Research Council

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic

Hepatitis, Viral, Human
Hepatitis C
Antiviral Agents
Hepatitis C, Chronic
Protease Inhibitors

Additional relevant MeSH terms:

Liver Diseases
RNA Virus Infections
Hepatitis, Chronic
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Hepatitis, Viral, Human
Enzyme Inhibitors

Pharmacologic Actions
Protease Inhibitors
Hepatitis
Virus Diseases
Digestive System Diseases
Hepatitis C
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on May 07, 2009