Safety and Efficacy of ANA598 Administered With Pegylated Interferon and Ribavirin in Genotype-1 Patients With Chronic HCV Infection
Assess the safety and efficacy of ANA598 administered with Pegylated Interferon and Ribavirin in Genotype 1 Patients with Chronic Hepatitis C Infection.
Drug: Pegylated Interferon
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 Trial of the Safety and Efficacy of ANA598 Administered With Pegylated Interferon and Ribavirin in Genotype 1 Patients With Chronic Hepatitis C Infection|
- SVR 24 (Sustained Virologic Response) [ Time Frame: 24 weeks after completing therapy ] [ Designated as safety issue: No ]Defined as undetectable HCV RNA 24 weeks after completing treatment
- Undetectable HCV RNA [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]Assess the comparative proportion of patients achieving undetectable HCV RNA (defined as HCV RNA <15 IU/mL) at each visit through Week 24
- SVR 12 [ Time Frame: 12 weeks after completing therapy ] [ Designated as safety issue: No ]Defined as undetectable HCV RNA 12 wks after completing treatment
- Proportion of treatment-naive patients eligible to stop all treatment at Week 28 [ Time Frame: 28 Weeks ] [ Designated as safety issue: No ]
- Safety and tolerability of ANA598 [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]Assess the safety and tolerability of ANA598 co-administered with standard-of-care (SOC) during 28 or 48 weeks of treatment
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||May 2013|
|Estimated Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
ANA598 200mg BID (28 or 48 Weeks) + co-administered pegylated interferon and ribavirin
Oral 200mg BIDDrug: Ribavirin
RibavirinDrug: Pegylated Interferon
Placebo Comparator: Placebo Comparator
Matching ANA598 placebo (28 or 48 Weeks) + co-administered pegylated interferon and ribavirin
Oral BIDDrug: Ribavirin
RibavirinDrug: Pegylated Interferon
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01281423
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|Study Director:||Clinical Trials||Hoffmann-La Roche|