Safety, Tolerability and Antiviral Activity of ACH-0141625 or Placebo in Combination With Peginterferon and Ribavirin in HCV Positive Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Achillion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01180790
First received: August 11, 2010
Last updated: January 15, 2014
Last verified: January 2014

August 11, 2010
January 15, 2014
September 2010
April 2012   (final data collection date for primary outcome measure)
  • Safety [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Adverse events, serious adverse events, physical exam findings, clinical laboratory results, vital sign assessments and ECG assessments
  • Rapid Viral Response at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Adverse events, serious adverse events, physical exam findings, clinical laboratory assessments, vital signs assessments and ECG findings.
Same as current
Complete list of historical versions of study NCT01180790 on ClinicalTrials.gov Archive Site
  • Early virologic response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Complete early virologic response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • End of treatment response [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Sustained virologic response [ Time Frame: Week 60 ] [ Designated as safety issue: No ]
  • Sustained virologic response [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
  • Time to undetectable HCV RNA [ Time Frame: 1 to 28 days ] [ Designated as safety issue: No ]
  • HCV RNA change from baseline [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • HCV RNA change from baseline [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • HCV RNA change from baseline [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • HCV RNA change from baseline [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • HCV RNA change from baseline [ Time Frame: Week 60 ] [ Designated as safety issue: No ]
  • HCV RNA change from baseline [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety, Tolerability and Antiviral Activity of ACH-0141625 or Placebo in Combination With Peginterferon and Ribavirin in HCV Positive Subjects
A Phase IIa, Randomized, Double-blind (Subject and Investigator Blind, Sponsor Open), Placebo-controlled Trial to Evaluate the Safety, Tolerability and Antiviral Activity of Oral ACH-0141625 in Combination With Pegylated Interferon Alpha-2a and Ribavirin in Two Segments, After 28 Days of Dosing and, Subsequently, After 12 Weeks of Dosing in Subjects With Chronic Hepatitis C Virus Genotype 1

Evaluate safety, tolerability and antiviral response of ACH-0141625 compared to Standard of Care in HCV positive subjects.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hepatitis C
  • Drug: ACH-0141625
    200 mg oral capsule once daily for 28 days or for 12 weeks
  • Drug: ACH-0141625
    400 mg oral capsule once daily for 28 days or for 12 weeks
  • Drug: ACH-0141625
    800 mg oral capsule once daily for 28 days or for 12 weeks
  • Drug: Placebo
    Powder in capsule once daily for 28 days
  • Drug: Pegylated Interferon alpha-2a
    180 ug once a week by subcutaneous injection for 48 weeks
    Other Name: PEGASYS
  • Drug: ribavirin
    400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks
    Other Names:
    • Ribasphere
    • Copegus
  • Experimental: Segment 1: 200 mg ACH-0141625
    200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks
    Interventions:
    • Drug: ACH-0141625
    • Drug: Pegylated Interferon alpha-2a
    • Drug: ribavirin
  • Experimental: Segment 1: 400 mg ACH-0141625
    400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
    Interventions:
    • Drug: ACH-0141625
    • Drug: Pegylated Interferon alpha-2a
    • Drug: ribavirin
  • Experimental: Segment 1: 800 mg ACH-0141625
    800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
    Interventions:
    • Drug: ACH-0141625
    • Drug: Pegylated Interferon alpha-2a
    • Drug: ribavirin
  • Placebo Comparator: Segment 1: Placebo
    Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
    Interventions:
    • Drug: Placebo
    • Drug: Pegylated Interferon alpha-2a
    • Drug: ribavirin
  • Experimental: Segment 2: 200 mg ACH-0141625
    200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks
    Interventions:
    • Drug: ACH-0141625
    • Drug: Pegylated Interferon alpha-2a
    • Drug: ribavirin
  • Experimental: Segment 2 - 400 mg ACH-0141625
    400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks
    Interventions:
    • Drug: ACH-0141625
    • Drug: Pegylated Interferon alpha-2a
    • Drug: ribavirin
  • Experimental: Segment 2 - 800 mg ACH-0141625
    800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks
    Interventions:
    • Drug: ACH-0141625
    • Drug: Pegylated Interferon alpha-2a
    • Drug: ribavirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
April 2013
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females 18 years and older
  • Chronic hepatitis C Genotype 1
  • Treatment naive

Exclusion Criteria:

  • BMI <36
  • Females of childbearing potential
  • Coinfection with HBV and/or HIV
  • Other significant disease including liver disease
  • History of drug or alcohol dependence or addiction within the past 6 months
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium
 
NCT01180790
ACH625-003, 2010-022092-65
Not Provided
Achillion Pharmaceuticals
Achillion Pharmaceuticals
Not Provided
Study Director: Elizabeth Olek, DO, RPh, MPH Achillion Pharmaceuticals
Achillion Pharmaceuticals
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP