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

Primary Purpose

HCV Infection

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
placebo
ANA598
ANA598
Peginterferon
Ribavirin
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HCV Infection

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

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

Sites / Locations

  • United States, California 1
  • United States, California 4
  • United States, California 2
  • United States, California 3
  • United States, California 5
  • United States, Florida 2
  • United States, Florida 3
  • United States, Florida 1
  • United States, Maryland
  • United States, Massachusetts
  • United States, Michigan
  • United States, New York
  • United States, North Carolina
  • United States, North Carolina
  • United States, Ohio
  • United States, Pennsylvania
  • United States, Texas 2
  • United States, Texas 1
  • United States, Virginia 1
  • United States, Virginia 2
  • Puerto Rico

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

1

2

3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Undetectable HCV RNA

Secondary Outcome Measures

Safety and Tolerability
Undetectable HCV RNA
ANA598, Peg-IFN-a-2-a, ribavirin concentrations
Undetectable HCV RNA

Full Information

First Posted
September 16, 2009
Last Updated
March 29, 2017
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00978497
Brief Title
Safety, Tolerability, and Antiviral Activity of ANA598 Administered in Combination With Pegylated Interferon and Ribavirin for the Treatment of Genotype-1 Chronic HCV Infection
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HCV Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Peginterferon and ribavirin + placebo BID for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks
Arm Title
2
Arm Type
Experimental
Arm Description
ANA598 200 mg BID + Peginterferon and ribavirin for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks
Arm Title
3
Arm Type
Experimental
Arm Description
ANA598 400mg BID + Peginterferon and ribavirin for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral BID
Intervention Type
Drug
Intervention Name(s)
ANA598
Intervention Description
oral 200mg BID
Intervention Type
Drug
Intervention Name(s)
ANA598
Intervention Description
oral 400mg BID
Intervention Type
Drug
Intervention Name(s)
Peginterferon
Intervention Description
180 μg dose via subcutaneous injection weekly
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
oral 1000 mg/day for patients who weighed < 75 kg and 1200 mg/day for patients who weighed ≥ 75 kg
Primary Outcome Measure Information:
Title
Undetectable HCV RNA
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Safety and Tolerability
Time Frame
Throughout study
Title
Undetectable HCV RNA
Time Frame
Week 4, Week 24, and Week 48
Title
ANA598, Peg-IFN-a-2-a, ribavirin concentrations
Time Frame
Various time points through Week 12
Title
Undetectable HCV RNA
Time Frame
24 weeks after completion of therapy for sustained virologic response [SVR]

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 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
Facility Information:
Facility Name
United States, California 1
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
United States, California 4
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
United States, California 2
City
San Clemente
State/Province
California
ZIP/Postal Code
92673
Country
United States
Facility Name
United States, California 3
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
United States, California 5
City
San Francisco
State/Province
California
ZIP/Postal Code
33136
Country
United States
Facility Name
United States, Florida 2
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32601
Country
United States
Facility Name
United States, Florida 3
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
United States, Florida 1
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
United States, Maryland
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
United States, Massachusetts
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
United States, Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
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, North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
United States, North Carolina
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
United States, Ohio
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
United States, Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
United States, Texas 2
City
Houston
State/Province
Texas
ZIP/Postal Code
77073
Country
United States
Facility Name
United States, Texas 1
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
United States, Virginia 1
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
United States, Virginia 2
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Puerto Rico
City
Santurce
ZIP/Postal Code
00909
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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