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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
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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 ]
  • The antiviral activity of ANA598, assessed by changes in serum HCV RNA levels [ Time Frame: 10 days ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00782353     History of Changes
Other Study ID Numbers: ANA598-502
First Submitted: October 28, 2008
First Posted: October 31, 2008
Last Update Posted: November 14, 2012
Last Verified: November 2012

Keywords provided by Hoffmann-La Roche:
HCV

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Antiviral Agents
Anti-Infective Agents


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