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

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ANA598 200 mg bid or placebo
ANA598 400 mg bid or placebo
ANA598 800 mg bid or placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring HCV

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • United States, Missouri
  • United States, New York
  • United States, Texas
  • Puerto Rico, Santurce

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

The safety and tolerability of ascending multiple oral doses of ANA598 administered for 3 days to adult patients with chronic HCV infection and compensated liver disease;
The antiviral activity of ANA598, assessed by changes in serum HCV RNA levels

Secondary Outcome Measures

Full Information

First Posted
October 28, 2008
Last Updated
November 12, 2012
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00782353
Brief Title
Safety, Tolerability, and Antiviral Activity of ANA598 in Patients With Genotype-1 Chronic HCV Infection
Official Title
A Phase 1, Randomized, Double-Blind, Ascending Multiple-Dose Study of the Safety, Tolerability, and Antiviral Activity of ANA598 in Patients With Chronic Hepatitis C Infection
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
HCV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Subjects randomized 8:2 (active:placebo) to receive ANA598 200 mg bid
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Subjects randomized 8:2 (active:placebo) to receive ANA598 400 mg bid
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Subjects randomized 8:2 (active:placebo) to receive ANA598 800 mg bid
Intervention Type
Drug
Intervention Name(s)
ANA598 200 mg bid or placebo
Intervention Description
ANA598 200 mg bid or placebo
Intervention Type
Drug
Intervention Name(s)
ANA598 400 mg bid or placebo
Intervention Description
ANA598 400 mg bid or placebo
Intervention Type
Drug
Intervention Name(s)
ANA598 800 mg bid or placebo
Intervention Description
ANA598 800 mg bid or placebo
Primary Outcome Measure Information:
Title
The safety and tolerability of ascending multiple oral doses of ANA598 administered for 3 days to adult patients with chronic HCV infection and compensated liver disease;
Time Frame
10 days
Title
The antiviral activity of ANA598, assessed by changes in serum HCV RNA levels
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Facility Information:
Facility Name
United States, Missouri
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
United States, New York
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
United States, Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Puerto Rico, Santurce
City
Santurce
ZIP/Postal Code
00909
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
25456558
Citation
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.
Results Reference
derived

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

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