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

Roche

Status and phase: Completed; Phase 2

Conditions: HCV Infection

Treatments: Drug: Peginterferon; Drug: ANA598; Drug: placebo; Drug: Ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00978497

ANA598-504

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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97 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Peginterferon and ribavirin + placebo BID for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks

Treatment:

Drug: placebo

Drug: Ribavirin

Drug: Peginterferon

2

Experimental group

Description:

ANA598 200 mg BID + Peginterferon and ribavirin for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks

Treatment:

Drug: ANA598

Drug: Ribavirin

Drug: ANA598

Drug: Peginterferon

3

Experimental group

Description:

ANA598 400mg BID + Peginterferon and ribavirin for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks

Treatment:

Drug: ANA598

Drug: Ribavirin

Drug: ANA598

Drug: Peginterferon