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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

Primary Purpose

Hepatitis C, Chronic

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

RO5024048

danoprevir

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Arm Label

Cohort A

Cohort B

Cohort C

Cohort D

Cohort E

Cohort F

Cohort G

Arm Description

Outcomes

Primary Outcome Measures

HCV RNA

Adverse events, laboratory parameters, vital signs

Secondary Outcome Measures

PK parameters;viral resistance

Full Information

NCT ID

NCT00801255

First Posted

December 2, 2008

Last Updated

November 1, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT00801255

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C, Chronic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort A

Arm Type

Experimental

Arm Title

Cohort B

Arm Type

Experimental

Arm Title

Cohort C

Arm Type

Experimental

Arm Title

Cohort D

Arm Type

Experimental

Arm Title

Cohort E

Arm Type

Experimental

Arm Title

Cohort F

Arm Type

Experimental

Arm Title

Cohort G

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

RO5024048

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

danoprevir

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

danoprevir

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

danoprevir

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

danoprevir

Intervention Description

1000mg/600mg po twice daily for 14 days

Intervention Type

Drug

Intervention Name(s)

danoprevir

Intervention Description

1000mg/900mg po twice daily for 14 days

Primary Outcome Measure Information:

Title

HCV RNA

Time Frame

At each clinic visit, throughout study

Title

Adverse events, laboratory parameters, vital signs

Time Frame

At each clinic visit, throughout study

Secondary Outcome Measure Information:

Title

PK parameters;viral resistance

Time Frame

At intervals, throughout study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

City

Adelaide

ZIP/Postal Code

SA 5000

Country

Australia

City

Heidelberg

ZIP/Postal Code

3084

Country

Australia

City

Melbourne

ZIP/Postal Code

3181

Country

Australia

City

Christchurch

ZIP/Postal Code

8011

Country

New Zealand

City

Grafton

ZIP/Postal Code

1150

Country

New Zealand

12. IPD Sharing Statement

Citations:

PubMed Identifier

20951424

Citation

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.

Results Reference

derived

Learn more about this trial

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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