MedDataX Logo

Safety, Tolerability, and Antiviral Activity of ANA598 in Patients With Genotype-1 Chronic HCV Infection

NCT ID: NCT00782353

Last Updated: 2012-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to investigate the safety, tolerability, and antiviral activity of ANA598 in patients with genotype-1 chronic hepatitis C infection.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The safety, tolerability and antiviral activity of ANA598, administered orally twice daily for 3 days, will be compared to placebo in treatment-naïve subjects chronically infected with HCV genotype 1 infection. Thirty (30) subjects will be randomized to one of three cohorts described above. The ten patients in each cohort will be randomized 8 active: 2 placebo. At least 5 subjects with genotype 1a and 5 subjects with genotype 1b will be enrolled within each cohort.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Hepatitis C

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

HCV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1

Subjects randomized 8:2 (active:placebo) to receive ANA598 200 mg bid

Group Type EXPERIMENTAL

ANA598 200 mg bid or placebo

Intervention Type DRUG

ANA598 200 mg bid or placebo

Cohort 2

Subjects randomized 8:2 (active:placebo) to receive ANA598 400 mg bid

Group Type EXPERIMENTAL

ANA598 400 mg bid or placebo

Intervention Type DRUG

ANA598 400 mg bid or placebo

Cohort 3

Subjects randomized 8:2 (active:placebo) to receive ANA598 800 mg bid

Group Type EXPERIMENTAL

ANA598 800 mg bid or placebo

Intervention Type DRUG

ANA598 800 mg bid or placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ANA598 200 mg bid or placebo

ANA598 200 mg bid or placebo

Intervention Type DRUG

ANA598 400 mg bid or placebo

ANA598 400 mg bid or placebo

Intervention Type DRUG

ANA598 800 mg bid or placebo

ANA598 800 mg bid or placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female, ages 18 to 65 years
* Documented chronic HCV infection, genotype 1a or 1b
* Treatment-naïve
* BMI = 18 - 35 kg/m2

Exclusion Criteria

* Female patients who are pregnant or breast-feeding
* Previous treatment for HCV infection
* HIV or HBV positive
* Evidence of cirrhosis on previous liver biopsy or on previous imaging studies
* History of any other known cause of liver disease;
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

United States, Missouri

St Louis, Missouri, United States

Site Status

United States, New York

New York, New York, United States

Site Status

United States, Texas

San Antonio, Texas, United States

Site Status

Puerto Rico, Santurce

Santurce, , Puerto Rico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Puerto Rico

References

Explore related publications, articles, or registry entries linked to this study.

Mallalieu NL, Rahimy MH, Crowley CA, Appleman JR, Smith PF, Freddo JL. Pharmacokinetics and pharmacodynamics of setrobuvir, an orally administered hepatitis C virus non-nucleoside analogue inhibitor. Clin Ther. 2014 Dec 1;36(12):2047-2063.e3. doi: 10.1016/j.clinthera.2014.10.002. Epub 2014 Nov 4.

Reference Type DERIVED
PMID: 25456558 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ANA598-502

Identifier Type: -

Identifier Source: org_study_id