NCT00801255

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2008

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1.3 years

First QC Date

December 2, 2008

Last Update Submit

November 1, 2016

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (2)

  • HCV RNA

    At each clinic visit, throughout study

  • Adverse events, laboratory parameters, vital signs

    At each clinic visit, throughout study

Secondary Outcomes (1)

  • PK parameters;viral resistance

    At intervals, throughout study

Study Arms (7)

Cohort A

EXPERIMENTAL
Drug: RO5024048

Cohort B

EXPERIMENTAL
Drug: danoprevir

Cohort C

EXPERIMENTAL
Drug: danoprevir

Cohort D

EXPERIMENTAL
Drug: danoprevir

Cohort E

EXPERIMENTAL
Drug: danoprevir

Cohort F

EXPERIMENTAL
Drug: danoprevir

Cohort G

EXPERIMENTAL
Drug: danoprevir

Interventions

RO5024048DRUG

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

Cohort A
danoprevirDRUG

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

Cohort B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients, 18-65 years of age;
  • chronic hepatitis C, genotype 1.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Adelaide, SA 5000, Australia

Location

Unknown Facility

Heidelberg, 3084, Australia

Location

Unknown Facility

Melbourne, 3181, Australia

Location

Unknown Facility

Christchurch, 8011, New Zealand

Location

Unknown Facility

Grafton, 1150, New Zealand

Location

Related Publications (1)

  • 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.

    PMID: 20951424DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

danoprevir

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2008

First Posted

December 3, 2008

Study Start

November 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

AU(3)NZ(2)