MedTrace Logo

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

NCT00978497 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2017-03-31

No results posted yet for this study

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.

Conditions

  • HCV Infection

Interventions

DRUG

placebo

oral BID

DRUG

ANA598

oral 200mg BID

DRUG

ANA598

oral 400mg BID

DRUG

Peginterferon

180 μg dose via subcutaneous injection weekly

DRUG

Ribavirin

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-04-30
Completion
2011-08-31

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00978497 on ClinicalTrials.gov