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Safety, Tolerability, and Antiviral Activity of ANA598 in Patients With Genotype-1 Chronic HCV Infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00782353
First Posted: October 31, 2008
Last Update Posted: November 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
October 28, 2008
October 31, 2008
November 14, 2012
October 2008
March 2009   (Final data collection date for primary outcome measure)
  • The safety and tolerability of ascending multiple oral doses of ANA598 administered for 3 days to adult patients with chronic HCV infection and compensated liver disease; [ Time Frame: 10 days ]
  • The antiviral activity of ANA598, assessed by changes in serum HCV RNA levels [ Time Frame: 10 days ]
Same as current
Complete list of historical versions of study NCT00782353 on ClinicalTrials.gov Archive Site
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Not Provided
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Safety, Tolerability, and Antiviral Activity of ANA598 in Patients With Genotype-1 Chronic HCV Infection
A Phase 1, Randomized, Double-Blind, Ascending Multiple-Dose Study of the Safety, Tolerability, and Antiviral Activity of ANA598 in Patients With Chronic Hepatitis C Infection
The purpose of this study is to investigate the safety, tolerability, and antiviral activity of ANA598 in patients with genotype-1 chronic hepatitis C infection.
The safety, tolerability and antiviral activity of ANA598, administered orally twice daily for 3 days, will be compared to placebo in treatment-naïve subjects chronically infected with HCV genotype 1 infection. Thirty (30) subjects will be randomized to one of three cohorts described above. The ten patients in each cohort will be randomized 8 active: 2 placebo. At least 5 subjects with genotype 1a and 5 subjects with genotype 1b will be enrolled within each cohort.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Hepatitis C
  • Drug: ANA598 200 mg bid or placebo
    ANA598 200 mg bid or placebo
  • Drug: ANA598 400 mg bid or placebo
    ANA598 400 mg bid or placebo
  • Drug: ANA598 800 mg bid or placebo
    ANA598 800 mg bid or placebo
  • Experimental: Cohort 1
    Subjects randomized 8:2 (active:placebo) to receive ANA598 200 mg bid
    Intervention: Drug: ANA598 200 mg bid or placebo
  • Experimental: Cohort 2
    Subjects randomized 8:2 (active:placebo) to receive ANA598 400 mg bid
    Intervention: Drug: ANA598 400 mg bid or placebo
  • Experimental: Cohort 3
    Subjects randomized 8:2 (active:placebo) to receive ANA598 800 mg bid
    Intervention: Drug: ANA598 800 mg bid or placebo
Mallalieu NL, Rahimy MH, Crowley CA, Appleman JR, Smith PF, Freddo JL. Pharmacokinetics and pharmacodynamics of setrobuvir, an orally administered hepatitis C virus non-nucleoside analogue inhibitor. Clin Ther. 2014 Dec 1;36(12):2047-2063.e3. doi: 10.1016/j.clinthera.2014.10.002. Epub 2014 Nov 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
March 2009
March 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female, ages 18 to 65 years
  • Documented chronic HCV infection, genotype 1a or 1b
  • Treatment-naïve
  • BMI = 18 - 35 kg/m2

Exclusion Criteria:

  • Female patients who are pregnant or breast-feeding
  • Previous treatment for HCV infection
  • HIV or HBV positive
  • Evidence of cirrhosis on previous liver biopsy or on previous imaging studies
  • History of any other known cause of liver disease;
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT00782353
ANA598-502
No
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Not Provided
Hoffmann-La Roche
November 2012

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