Clinical trial NCT00978497: Safety, Tolerability, and Antiviral Activity of ANA598 Administered in Combination With Pegylated Interferon and Ribavirin for the Treatment of Genotype-1 Chronic HCV Infection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HCV Infection
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-09-17
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Undetectable HCV RNA
timeFrame: 12 Weeks
Secondary outcomes:
measure: Safety and Tolerability
timeFrame: Throughout study
measure: Undetectable HCV RNA
timeFrame: Week 4, Week 24, and Week 48
measure: ANA598, Peg-IFN-a-2-a, ribavirin concentrations
timeFrame: Various time points through Week 12
measure: Undetectable HCV RNA
timeFrame: 24 weeks after completion of therapy for sustained virologic response [SVR]
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: United States, California 1
state: California
city: Los Angeles
country: United States
facility: United States, California 4
state: California
city: San Clemente
country: United States
facility: United States, California 2
state: California
city: San Diego
country: United States
facility: United States, California 3
state: California
city: San Francisco
country: United States
facility: United States, California 5
state: California
city: Gainesville
country: United States
facility: United States, Florida 2
state: Florida
city: Miami
country: United States
facility: United States, Florida 3
state: Florida
city: Sarasota
country: United States
facility: United States, Florida 1
state: Florida
city: Lutherville
country: United States
facility: United States, Maryland
state: Maryland
city: Boston
country: United States
facility: United States, Massachusetts
state: Massachusetts
city: Detroit
country: United States
facility: United States, Michigan
state: Michigan
city: New York
country: United States
facility: United States, New York
state: New York
city: Chapel Hill
country: United States
facility: United States, North Carolina
state: North Carolina
city: Durham
country: United States
facility: United States, North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: United States, Ohio
state: Ohio
city: Philadelphia
country: United States
facility: United States, Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: United States, Texas 2
state: Texas
city: San Antonio
country: United States
facility: United States, Texas 1
state: Texas
city: Fairfax
country: United States
facility: United States, Virginia 1
state: Virginia
city: Falls Church
country: United States
facility: United States, Virginia 2
state: Virginia
city: Santurce
country: Puerto Rico
facility: Puerto Rico
Study officials:
References: