Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00801255
First received: December 2, 2008
Last updated: November 24, 2014
Last verified: November 2014

December 2, 2008
November 24, 2014
November 2008
March 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • HCV RNA [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Adverse events, laboratory parameters, vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00801255 on ClinicalTrials.gov Archive Site
PK parameters;viral resistance [ Time Frame: At intervals, throughout study ] [ Designated as safety issue: No ]
PK parameters;viral resistance [ Time Frame: Throughhout study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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

This 7 cohort study will evaluate the efficacy and safety of combination treatme nt with an HCV nucleoside polymerase inhibitor(RO5024048)and an HCV protease inh ibitor(RO5190591/ITMN-191/danoprevir) in patients with chronic hepatitis C, geno type 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 respo nders. Cohorts A and B will evaluate doses of 500mg po bid RO5024048 and 100mg p

o 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.Coh ort 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 dai ly 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 ca re therapies. The anticipated time on study treatment is <3 months, and the targ et sample size is <100 individuals.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: RO5024048
    500mg po bid/100mg po q8h for 7 days
  • Drug: danoprevir
    500mg po bid/100mg po q8h for 14 days
  • Drug: danoprevir
    1000mg po bid/100mg po q8h for 14 days\n500mg po bid/200mg po q8h for 14 days
  • Drug: danoprevir
    1000mg po bid/200mg po q8h for 14 days
  • Drug: danoprevir
    1000mg/600mg po twice daily for 14 days
  • Drug: danoprevir
    1000mg/900mg po twice daily for 14 days
  • Experimental: Cohort A
    Intervention: Drug: RO5024048
  • Experimental: Cohort B
    Intervention: Drug: danoprevir
  • Experimental: Cohort C
    Intervention: Drug: danoprevir
  • Experimental: Cohort D
    Intervention: Drug: danoprevir
  • Experimental: Cohort E
    Intervention: Drug: danoprevir
  • Experimental: Cohort F
    Intervention: Drug: danoprevir
  • Experimental: Cohort G
    Intervention: Drug: danoprevir
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. Epub 2010 Oct 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia,   New Zealand
 
NCT00801255
PP22205
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP