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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:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00782353
First received: October 28, 2008
Last updated: November 12, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
 Drug: ANA598 200 mg bid or placebo
Drug: ANA598 400 mg bid or placebo
Drug: ANA598 800 mg bid or placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • The antiviral activity of ANA598, assessed by changes in serum HCV RNA levels [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: October 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Subjects randomized 8:2 (active:placebo) to receive ANA598 200 mg bid
 Drug: ANA598 200 mg bid or placebo
ANA598 200 mg bid or placebo
Experimental: Cohort 2
Subjects randomized 8:2 (active:placebo) to receive ANA598 400 mg bid
 Drug: ANA598 400 mg bid or placebo
ANA598 400 mg bid or placebo
Experimental: Cohort 3
Subjects randomized 8:2 (active:placebo) to receive ANA598 800 mg bid
 Drug: ANA598 800 mg bid or placebo
ANA598 800 mg bid or placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00782353

Locations
United States, Missouri
United States, Missouri
St. Louis, Missouri, United States, 63104
United States, New York
United States, New York
New York, New York, United States, 10021
United States, Texas
United States, Texas
San Antonio, Texas, United States, 78215
Puerto Rico
Puerto Rico, Santurce
Santurce, Puerto Rico, 00909
Sponsors and Collaborators
Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00782353     History of Changes
Other Study ID Numbers: ANA598-502
Study First Received: October 28, 2008
Last Updated: November 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Hoffmann-La Roche:
HCV

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013