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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00978497
First Posted: September 17, 2009
Last Update Posted: March 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention Phase
HCV Infection Drug: placebo Drug: ANA598 Drug: Peginterferon Drug: Ribavirin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Undetectable HCV RNA [ Time Frame: 12 Weeks ]

Secondary Outcome Measures:
  • Safety and Tolerability [ Time Frame: Throughout study ]
  • Undetectable HCV RNA [ Time Frame: Week 4, Week 24, and Week 48 ]
  • ANA598, Peg-IFN-a-2-a, ribavirin concentrations [ Time Frame: Various time points through Week 12 ]
  • Undetectable HCV RNA [ Time Frame: 24 weeks after completion of therapy for sustained virologic response [SVR] ]

Enrollment: 97
Study Start Date: September 2009
Study Completion Date: August 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Peginterferon and ribavirin + placebo BID for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks
Drug: placebo
oral 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
Experimental: 2
ANA598 200 mg BID + Peginterferon and ribavirin for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks
Drug: ANA598
oral 200mg 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
Experimental: 3
ANA598 400mg BID + Peginterferon and ribavirin for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978497


Locations
United States, California
United States, California 1
Anaheim, California, United States, 92801
United States, California 4
Los Angeles, California, United States, 90048
United States, California 2
San Clemente, California, United States, 92673
United States, California 3
San Diego, California, United States, 92120
United States, California 5
San Francisco, California, United States, 33136
United States, Florida
United States, Florida 2
Gainesville, Florida, United States, 32601
United States, Florida 3
Miami, Florida, United States, 33136
United States, Florida 1
Sarasota, Florida, United States, 34209
United States, Maryland
United States, Maryland
Lutherville, Maryland, United States, 21093
United States, Massachusetts
United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, Michigan
United States, Michigan
Detroit, Michigan, United States, 48202
United States, New York
United States, New York
New York, New York, United States, 10021
United States, North Carolina
United States, North Carolina
Chapel Hill, North Carolina, United States, 27514
United States, North Carolina
Durham, North Carolina, United States, 27705
United States, Ohio
United States, Ohio
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
United States, Texas 2
Houston, Texas, United States, 77073
United States, Texas 1
San Antonio, Texas, United States, 78215
United States, Virginia
United States, Virginia 1
Fairfax, Virginia, United States, 22031
United States, Virginia 2
Falls Church, Virginia, United States, 22042
Puerto Rico
Puerto Rico
Santurce, Puerto Rico, 00909
Sponsors and Collaborators
Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00978497     History of Changes
Other Study ID Numbers: ANA598-504
First Submitted: September 16, 2009
First Posted: September 17, 2009
Last Update Posted: March 31, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Infection
Communicable Diseases
Interferons
Ribavirin
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action