Safety and Efficacy of ANA598 Administered With Pegylated Interferon and Ribavirin in Genotype-1 Patients With Chronic HCV Infection

Hepatitis C Clinical Trial

Official title:

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of ANA598 Administered With Pegylated Interferon and Ribavirin in Genotype 1 Patients With Chronic Hepatitis C Infection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01281423
• Other study ID #: ANA598-505
• Secondary ID: Control No. 1434
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 20, 2011
• Last updated: November 20, 2012
• Start date: December 2010
• Est. completion date: May 2013

Study information

• Verified date: November 2012
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Assess the safety and efficacy of ANA598 administered with Pegylated Interferon and Ribavirin in Genotype 1 Patients with Chronic Hepatitis C Infection.

Description:

Eligible patients with chronic hepatitis C infection (HCV genotype 1) will be randomized to treatment with 200 mg BID (total daily dose 400 mg) ANA598 or matching placebo, while receiving co-administered pegylated interferon and ribavirin (standard-of-care, SOC). All patients receiving ANA598 will receive a loading dose of 800 mg BID (total dose 1600 mg) on Day 1.

Treatment-Naïve Patients:

Enrollment will include approximately 133 treatment-naïve Genotype 1 patients with chronic HCV infection (100 randomized to receive ANA598 + SOC, and 33 randomized to receive matching placebo + SOC).

Treatment-naïve patients will be treated for either 28 weeks or 48 weeks, depending on response to treatment. Patients with undetectable HCV RNA at Week 8 and at subsequent visits will complete all treatment at Week 28.

Patients with Prior SOC Treatment (All will receive 48 Weeks of therapy):

Approximately 113 patients categorized as having prior relapse , prior partial response or prior viral breakthrough to previous treatment will be randomized to treatment with ANA598 200 mg BID + SOC or placebo + SOC (80 randomized to be treated with ANA598 + SOC, and 33 randomized to be treated with placebo + SOC).

Approximately 28 treatment-experienced patients categorized as null responders to previous treatment will be assigned treatment for 48 weeks with ANA598 200mg BID and co-administered pegylated interferon and ribavirin.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 274
• Est. completion date: May 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Documented chronic hepatitis C infection, genotype 1 at screening

• Treatment-naïve; no prior exposure to pegylated interferon, ribavirin, or experimental HCV therapy

• Treatment-experienced patients including Partial responders, Prior relapse, Prior viral breakthrough, and Null responders; prior treatment with current standard of care (pegylated interferon alfa and ribavirin)

Exclusion Criteria:

• Female patients who are pregnant or breast feeding

• Infection with non-genotype 1 HCV

• For treatment-naïve patients: any previous treatment for HCV infection

• For treatment-experienced patients: previous treatment with any direct-acting antivirals for HCV infection

• Known HIV or HBV co-infection

• Any medical contraindications to Peg-INF or RBV therapy

• History of any other known cause of liver disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

Drug:
• Placebo
Oral BID
• ANA598
Oral 200mg BID
• Ribavirin
Ribavirin
• Pegylated Interferon
Pegylated Interferon

Locations

Country	Name	City	State
Australia	Australia, Clayton 1	Clayton	Victoria
Australia	Australia, Fitzroy 1	Fitzroy	Victoria
Australia	Australia, Greenslopes 1	Greenslopes	Queensland
Australia	Australia, Melbourne 1	Melbourne	Victoria
Australia	Australia, Perth 1	Perth	Western Australia
Australia	Australia, Woolloongabba 1	Woolloongabba	Queensland
Canada	Canada, Edmonton 1	Edmonton	Alberta
Canada	Canada, Edmonton 2	Edmonton	Alberta
Canada	Canada, London 1	London	Ontario
Canada	Canada, Toronto 1	Toronto	Ontario
Canada	Canada, Vancouver 1	Vancouver	British Columbia
New Zealand	New Zealand, Christchurch 1	Christchurch	Canterbury
New Zealand	New Zealand, Grafton 1	Grafton	Auckland
New Zealand	New Zealand, Hamilton 1	Hamilton	Waikato
New Zealand	New Zealand, Newtown 1	Newtown	Wellington
United States	United States, Texas 5	Arlington	Texas
United States	United States, North Carolina 3	Asheville	North Carolina
United States	United States, California 3	Bakersfield	California
United States	United States, Washington 2	Bellevue	Washington
United States	United States, Florida 1	Bradenton	Florida
United States	United States, North Carolina 1	Chapel Hill	North Carolina
United States	United States, Illinois 1	Chicago	Illinois
United States	United States, Ohio 1	Cincinnati	Ohio
United States	United States, Texas 3	Dallas	Texas
United States	United States, Michigan 1	Detroit	Michigan
United States	United States, North Carolina 2	Durham	North Carolina
United States	United States, Colorado 2	Englewood	Colorado
United States	United States, Texas 1	Houston	Texas
United States	United States, Texas 4	Houston	Texas
United States	United States, Indiana 1	Indianapolis	Indiana
United States	United States, Missouri 2	Kansas City	Missouri
United States	United States, California 1	Los Angeles	California
United States	United States, Georgia 1	Marietta	Georgia
United States	United States, Illinois 2	Maywood	Illinois
United States	United States, Florida 2	Miami	Florida
United States	United States, Alabama 1	Montgomery	Alabama
United States	Unite States, Tennessee 2	Nashville	Tennessee
United States	United States, Tennessee 1	Nashville	Tennessee
United States	United States, New York 1	New York	New York
United States	United States, New Jersey 1	Newark	New Jersey
United States	United States, Virginia 1	Newport News	Virginia
United States	United States, Pennsylvania 1	Philadelphia	Pennsylvania
United States	United States, Missouri 1	Saint Louis	Missouri
United States	United States, Texas 2	San Antonio	Texas
United States	United States, Washington 1	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Canada,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SVR 24 (Sustained Virologic Response)	Defined as undetectable HCV RNA 24 weeks after completing treatment	24 weeks after completing therapy	No
Secondary	Undetectable HCV RNA	Assess the comparative proportion of patients achieving undetectable HCV RNA (defined as HCV RNA <15 IU/mL) at each visit through Week 24	24 Weeks	No
Secondary	SVR 12	Defined as undetectable HCV RNA 12 wks after completing treatment	12 weeks after completing therapy	No
Secondary	Proportion of treatment-naive patients eligible to stop all treatment at Week 28		28 Weeks	No
Secondary	Safety and tolerability of ANA598	Assess the safety and tolerability of ANA598 co-administered with standard-of-care (SOC) during 28 or 48 weeks of treatment	48 Weeks	Yes