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:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00978497
First received: September 16, 2009
Last updated: November 12, 2012
Last verified: November 2012
  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
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and Tolerability [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Undetectable HCV RNA [ Time Frame: Week 4, Week 24, and Week 48 ] [ Designated as safety issue: No ]
  • ANA598, Peg-IFN-a-2-a, ribavirin concentrations [ Time Frame: Various time points through Week 12 ] [ Designated as safety issue: No ]
  • Undetectable HCV RNA [ Time Frame: 24 weeks after completion of therapy for sustained virologic response [SVR] ] [ Designated as safety issue: No ]

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
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
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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00978497     History of Changes
Other Study ID Numbers: ANA598-504
Study First Received: September 16, 2009
Last Updated: November 12, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hepatitis C, Chronic
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014