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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01281423
First received: January 20, 2011
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Hepatitis C
Drug: Placebo
Drug: ANA598
Drug: Ribavirin
Drug: Pegylated Interferon
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 274
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)
Arms Assigned Interventions
Experimental: ANA598
ANA598 200mg BID (28 or 48 Weeks) + co-administered pegylated interferon and ribavirin
Drug: ANA598
Oral 200mg BID
Drug: Ribavirin
Ribavirin
Drug: Pegylated Interferon
Pegylated Interferon
Placebo Comparator: Placebo Comparator
Matching ANA598 placebo (28 or 48 Weeks) + co-administered pegylated interferon and ribavirin
Drug: Placebo
Oral BID
Drug: Ribavirin
Ribavirin
Drug: Pegylated Interferon
Pegylated Interferon

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01281423

  Show 45 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01281423     History of Changes
Other Study ID Numbers: ANA598-505, Control No. 143490
Study First Received: January 20, 2011
Last Updated: November 20, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

ClinicalTrials.gov processed this record on August 28, 2014