Safety, Tolerability, and Antiviral Activity of ANA598 Administered in Combination With Pegylated Interferon and Ribavirin for the Treatment of Genotype-1 Chronic HCV Infection

HCV Infection Clinical Trial

Official title:

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Trial of the Safety, Efficacy, and Pharmacokinetics of ANA598 Administered With Pegylated Interferon and Ribavirin in Treatment-Naïve Genotype 1 Patients With Chronic Hepatitis C Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00978497
• Other study ID #: ANA598-504
• Status: Completed
• Phase: Phase 2
• First received: September 16, 2009
• Last updated: March 29, 2017
• Start date: September 2009
• Est. completion date: August 2011

Study information

• Verified date: March 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety, tolerability and effectiveness of ANA598 when administered with pegylated interferon and ribavirin (Standard of Care [SOC]) compared to placebo + SOC.

Description:

The safety, tolerability and antiviral activity of ANA598, administered orally at 200 mg BID or 400 mg BID for 12 weeks in combination with pegylated interferon and ribavirin (SOC) will be compared to placebo + SOC. Treatment-naïve patients with genotype 1 infection will be eligible for enrollment. Patients randomized to ANA598 will receive a loading dose of 800 mg q 12 hours administered on the first day of dosing. Patients with undetectable HCV RNA at week 4 and week 12 will be randomized to receive either an additional 12 or 36 weeks of SOC alone.

Ninety patients will be randomized into 2 cohorts. The forty-five patients in each cohort will be randomized as 30 active: 15 placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: August 2011
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• 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

Exclusion Criteria:

• Female patients who are pregnant or breast-feeding

• Infection with non-genotype 1 HCV

• Previous treatment for HCV infection

• HIV or HBV positive

• Any medical contraindication to Peg-IFN or RBV therapy

• History of any other known cause of liver disease

Related Conditions & MeSH terms

• Communicable Diseases
• HCV Infection
• Infection

Intervention

Drug:
• placebo
oral BID
• ANA598
oral 200mg BID
• ANA598
oral 400mg BID
• Peginterferon
180 µg dose via subcutaneous injection weekly
• Ribavirin
oral 1000 mg/day for patients who weighed < 75 kg and 1200 mg/day for patients who weighed = 75 kg

Locations

Country	Name	City	State
Puerto Rico	Puerto Rico	Santurce
United States	United States, California 1	Anaheim	California
United States	United States, Massachusetts	Boston	Massachusetts
United States	United States, North Carolina	Chapel Hill	North Carolina
United States	United States, Ohio	Cincinnati	Ohio
United States	United States, Michigan	Detroit	Michigan
United States	United States, North Carolina	Durham	North Carolina
United States	United States, Virginia 1	Fairfax	Virginia
United States	United States, Virginia 2	Falls Church	Virginia
United States	United States, Florida 2	Gainesville	Florida
United States	United States, Texas 2	Houston	Texas
United States	United States, California 4	Los Angeles	California
United States	United States, Maryland	Lutherville	Maryland
United States	United States, Florida 3	Miami	Florida
United States	United States, New York	New York	New York
United States	United States, Pennsylvania	Philadelphia	Pennsylvania
United States	United States, Texas 1	San Antonio	Texas
United States	United States, California 2	San Clemente	California
United States	United States, California 3	San Diego	California
United States	United States, California 5	San Francisco	California
United States	United States, Florida 1	Sarasota	Florida

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	Undetectable HCV RNA		12 Weeks
Secondary	Safety and Tolerability		Throughout study
Secondary	Undetectable HCV RNA		Week 4, Week 24, and Week 48
Secondary	ANA598, Peg-IFN-a-2-a, ribavirin concentrations		Various time points through Week 12
Secondary	Undetectable HCV RNA		24 weeks after completion of therapy for sustained virologic response [SVR]