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

November 12, 2012 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Santurce, Puerto Rico, 00909
        • Puerto Rico, Santurce
  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63104
        • United States, Missouri
    • New York
      • New York, New York, United States, 10021
        • United States, New York
    • Texas
      • San Antonio, Texas, United States, 78215
        • United States, Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
10 days
The antiviral activity of ANA598, assessed by changes in serum HCV RNA levels
Time Frame: 10 days
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

October 28, 2008

First Submitted That Met QC Criteria

October 29, 2008

First Posted (Estimate)

October 31, 2008

Study Record Updates

Last Update Posted (Estimate)

November 14, 2012

Last Update Submitted That Met QC Criteria

November 12, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANA598-502

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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