Evaluation of Safety Tolerability and Antiviral Activity of ACH-0143102 Plus RBV Treatment Naive HCV GT1b Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Achillion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01700179
First received: October 2, 2012
Last updated: October 2, 2014
Last verified: October 2014
Results First Received: September 30, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Hepatitis C Infection
Interventions: Drug: ACH-0143102
Drug: Ribavirin

  Participant Flow
  Hide Participant Flow

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 6 sites in the US between September 5, 2012 and December 11, 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were screened within 4 weeks (-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.

Reporting Groups
  Description
ACH-0143102 Plus Ribavirin

ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. Weight-based RBV (as per the label) for Days 1-84.

ACH-0143102

Ribavirin


Participant Flow:   Overall Study
    ACH-0143102 Plus Ribavirin  
STARTED     8  
COMPLETED     6  
NOT COMPLETED     2  
Physician Decision                 2  



  Baseline Characteristics
  Hide Baseline Characteristics

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 analysis population for baseline characteristics was all enrolled subjects.

Reporting Groups
  Description
ACH-0143102 Plus Ribavirin

ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. RBV (as per label) for Days 1-84.

ACH-0143102

Ribavirin


Baseline Measures
    ACH-0143102 Plus Ribavirin  
Number of Participants  
[units: participants]
  8  
Age  
[units: years]
Mean ± Standard Deviation
  50.07  ± 11.34  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     8  
>=65 years     0  
Gender  
[units: participants]
 
Female     2  
Male     6  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     2  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     6  
More than one race     0  
Unknown or Not Reported     0  
Study-Specific Measure  
[units: kg/m^2]
Mean ± Standard Deviation
  28.13  ± 4.183  



  Outcome Measures

1.  Primary:   SVR12   [ Time Frame: 12 weeks following last dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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 of Clinical Operations
Organization: Achillion Pharmaceuticals
phone: 203-624-7000
e-mail: Kkucharski@achillion.com


No publications provided


Responsible Party: Achillion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01700179     History of Changes
Other Study ID Numbers: ACH102-005
Study First Received: October 2, 2012
Results First Received: September 30, 2014
Last Updated: October 2, 2014
Health Authority: United States: Food and Drug Administration