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: September 8, 2014
Last verified: September 2014
Results First Received: July 29, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hepatitis C
Interventions: Drug: ACH-0141625 (Sovaprevir)
Drug: Placebo
Drug: Pegylated Interferon alpha-2a
Drug: Ribavirin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from 15 sites in the United States and 3 sites in Belgium between September 30, 2010 and January 3, 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants screened within 4 weeks (Day -28 to -1) before administration of study drug. Subjects who meet all eligibility criteria were instructed to arrive at the study center on Baseline day for randomization to treatment assignment.

Reporting Groups
  Description
Segment 1: 200 mg ACH-0141625 for 28 Days

ACH-0141625: 200 mg oral capsule once daily

Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks

ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks

Segment 1: 400 mg ACH-0141625 for 28 Days

ACH-0141625: 400 mg oral capsule once daily

Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks

ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks

Segment 1: 800 mg ACH-0141625 for 28 Days

ACH-0141625: 800 mg oral capsule once daily

Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks

ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks

Segment 1: Placebo for 28 Days

Placebo: Powder in capsule once daily

Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks

ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks

Segment 2: 200 mg ACH-0141625 for 12 Weeks

ACH-0141625: 200 mg oral capsule once daily

Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks

ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for up to 24 or 48 weeks

Segment 2 - 400 mg ACH-0141625 for 12 Weeks

ACH-0141625: 400 mg oral capsule once daily

Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks

ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for up to 24 or 48 weeks

Segment 2 - 800 mg ACH-0141625 for 12 Weeks

ACH-0141625: 800 mg oral capsule once daily

Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks

ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for up to 24 or 48 weeks


Participant Flow:   Overall Study
    Segment 1: 200 mg ACH-0141625 for 28 Days     Segment 1: 400 mg ACH-0141625 for 28 Days     Segment 1: 800 mg ACH-0141625 for 28 Days     Segment 1: Placebo for 28 Days     Segment 2: 200 mg ACH-0141625 for 12 Weeks     Segment 2 - 400 mg ACH-0141625 for 12 Weeks     Segment 2 - 800 mg ACH-0141625 for 12 Weeks  
STARTED     16     16     17     15     19     20     19  
COMPLETED     7     11     4     6     14     13     18  
NOT COMPLETED     9     5     13     9     5     7     1  
Adverse Event                 1                 1                 2                 0                 1                 3                 0  
Withdrawal by Subject                 3                 0                 5                 0                 2                 1                 0  
Lost to Follow-up                 3                 1                 0                 2                 1                 0                 1  
Physician Decision                 1                 0                 0                 1                 0                 0                 0  
Lack of Efficacy                 1                 2                 5                 6                 1                 3                 0  
compliance                 0                 1                 0                 0                 0                 0                 0  
Severe coronary atherosclerosis (death)                 0                 0                 1                 0                 0                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) population, which was defined as all subjects randomized and treated with at least one dose of ACH 0141625 or Placebo. Subjects were analyzed according to the randomized treatment.

Reporting Groups
  Description
Segment 1: 200 mg ACH-0141625

200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks

ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks

Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks

ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks

Segment 1: 400 mg ACH-0141625

400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks

ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks

Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks

ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks

Segment 1: 800 mg ACH-0141625

800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks

ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks

Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks

ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks

Segment 1: Placebo

Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks

Placebo: Powder in capsule once daily for 28 days

Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks

ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks

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

ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks

Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks

ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks

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

ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks

Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks

ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks

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

ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks

Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks

ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks

Total Total of all reporting groups

Baseline Measures
    Segment 1: 200 mg ACH-0141625     Segment 1: 400 mg ACH-0141625     Segment 1: 800 mg ACH-0141625     Segment 1: Placebo     Segment 2: 200 mg ACH-0141625     Segment 2 - 400 mg ACH-0141625     Segment 2 - 800 mg ACH-0141625     Total  
Number of Participants  
[units: participants]
  16     16     17     15     19     20     19     122  
Age  
[units: years]
Mean ± Standard Deviation
  51  ± 7     51  ± 9     52  ± 13     47  ± 9     45  ± 11     48  ± 12     42  ± 12     48  ± 11  
Age  
[units: participants]
               
<=18 years     0     0     0     0     0     0     0     0  
Between 18 and 65 years     15     16     16     15     19     19     19     119  
>=65 years     1     0     1     0     0     1     0     3  
Gender  
[units: participants]
               
Female     3     6     4     4     7     5     9     38  
Male     13     10     13     11     12     15     10     84  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Segment 1: Safety   [ Time Frame: 4 weeks ]

2.  Primary:   Segment 1 : Rapid Viral Response at Week 4 (RVR4)   [ Time Frame: 4 weeks ]

3.  Primary:   Segment 2: Safety   [ Time Frame: 12 weeks ]

4.  Primary:   Segment 2: Complete Early Virologic Response (cEVR)   [ Time Frame: Week 12 ]

5.  Secondary:   Segment 1: Complete Early Virologic Response (cEVR)   [ Time Frame: 12 weeks ]

6.  Secondary:   Segment 2: RVR4 (Rapid Viral Response at 4 Weeks)   [ Time Frame: 4 weeks ]

7.  Secondary:   Segment 1 and Segment 2: End of Treatment Response   [ Time Frame: Week 48 (Segment 1); Week 24 (Segment 2) ]

8.  Secondary:   Segment 1 and Segment 2: Sustained Virologic Response 12 Weeks ( Three Months Post Dosing) (SVR12)   [ Time Frame: 3 months post dosing ]

9.  Secondary:   Segment 1 and Segment 2: Sustained Virologic Response ( Six Months Post Dosing) (SVR24)   [ Time Frame: 6 months post dosing ]

10.  Secondary:   Segment 1 and Segment 2: HCV RNA Change From Baseline   [ Time Frame: Week 4 ]

11.  Secondary:   Segment 1 and Segment 2: HCV RNA Change From Baseline   [ Time Frame: Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Kevin Kucharski, VP Clinical Operations
Organization: Achillion Pharmaceuticals, Inc.
phone: 203-624-7000
e-mail: Kkucharski@achillion.com


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
Results First Received: July 29, 2014
Last Updated: September 8, 2014
Health Authority: United States: Food and Drug Administration