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
  Purpose

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


Condition Intervention Phase
Hepatitis C
Drug: ACH-0141625
Drug: Placebo
Drug: Pegylated Interferon alpha-2a
Drug: ribavirin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Achillion Pharmaceuticals:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 128
Study Start Date: September 2010
Study Completion Date: April 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Segment 1: 200 mg ACH-0141625
200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks
Drug: ACH-0141625
200 mg oral capsule once daily for 28 days or for 12 weeks
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: 400 mg ACH-0141625
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
Drug: ACH-0141625
400 mg oral capsule once daily for 28 days or for 12 weeks
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: 800 mg ACH-0141625
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
Drug: ACH-0141625
800 mg oral capsule once daily for 28 days or for 12 weeks
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
Placebo Comparator: Segment 1: Placebo
Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 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 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
Drug: ACH-0141625
200 mg oral capsule once daily for 28 days or for 12 weeks
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 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
Drug: ACH-0141625
400 mg oral capsule once daily for 28 days or for 12 weeks
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 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
Drug: ACH-0141625
800 mg oral capsule once daily for 28 days or for 12 weeks
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180790

Locations
United States, California
Axis Clinical Trials
Los Angeles, California, United States, 90036
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Quest Clinical Research
San Francisco, California, United States, 94115
United States, Florida
Pointe West Infectious Disease
Brandenton, Florida, United States, 34209
Orlando Immunology Center
Orlando, Florida, United States, 32803
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Kansas
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66211
United States, Missouri
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, United States, 64131
St. Louis University
St. Louis, Missouri, United States, 63104
United States, Nevada
Impact Clinical Trials
Las Vegas, Nevada, United States, 89106
United States, New Jersey
AGA Clinical Research Associates
Egg Harbor Township, New Jersey, United States, 08234
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10065
United States, Pennsylvania
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
United States, Texas
North Texas Research Institute
Arlington, Texas, United States, 76012
Alamo Medical Research
San Antonio, Texas, United States, 78215
United States, Virginia
Bon Secours St. Mary's Hospital of Richmond
Newport News, Virginia, United States, 23602
Belgium
Universitair Ziekenhuis Antwerpen
Edgem, Antwerp, Belgium, 2650
Centre Hospitalier de Jolimont-Lobbes
Haine-Saint-Paul, Hainaut, Belgium, 7100
Universitair Ziekenhuis Gent
Gent, Oost-Vlaanderen, Belgium, 9000
Sponsors and Collaborators
Achillion Pharmaceuticals
Investigators
Study Director: Elizabeth Olek, DO, RPh, MPH Achillion Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Achillion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01180790     History of Changes
Other Study ID Numbers: ACH625-003, 2010-022092-65
Study First Received: August 11, 2010
Last Updated: January 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Achillion Pharmaceuticals:
HCV
Hepatitis C Genotype 1

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a
Antiviral Agents
Interferons
Ribavirin
Peginterferon alfa-2a
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014