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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00978497

Enrollment

Registered

2009-09-17

Start date

2009-09-30

Completion date

2011-08-31

Last updated

2017-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCV Infection

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.

Interventions

DRUGplacebo

oral BID

DRUGANA598

oral 200mg BID

DRUGPeginterferon

180 μg dose via subcutaneous injection weekly

DRUGRibavirin

oral 1000 mg/day for patients who weighed \< 75 kg and 1200 mg/day for patients who weighed ≥ 75 kg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Undetectable HCV RNA	12 Weeks

Secondary

Measure	Time frame
Safety and Tolerability	Throughout study
Undetectable HCV RNA	Week 4, Week 24, and Week 48
ANA598, Peg-IFN-a-2-a, ribavirin concentrations	Various time points through Week 12

Countries

Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026