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

Chronic Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00782353
• Other study ID #: ANA598-502
• Status: Completed
• Phase: Phase 1
• First received: October 28, 2008
• Last updated: November 12, 2012
• Start date: October 2008
• Est. completion date: March 2009

Study information

• Verified date: November 2012
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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;

Study Design

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

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• ANA598 200 mg bid or placebo
ANA598 200 mg bid or placebo
• ANA598 400 mg bid or placebo
ANA598 400 mg bid or placebo
• ANA598 800 mg bid or placebo
ANA598 800 mg bid or placebo

Locations

Country	Name	City	State
Puerto Rico	Puerto Rico, Santurce	Santurce
United States	United States, New York	New York	New York
United States	United States, Texas	San Antonio	Texas
United States	United States, Missouri	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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;		10 days	Yes
Primary	The antiviral activity of ANA598, assessed by changes in serum HCV RNA levels		10 days	No