GS-7977 With Ribavirin for Hepatitis C (SPARE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT01441180
First received: September 24, 2011
Last updated: September 25, 2014
Last verified: September 2014
Results First Received: April 23, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis C
Interventions: Drug: GS7977
Drug: RBV

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Phase 1 (N =10): Participants will be enrolled and will receive GS-7977 QD in combination with RBV for a total of 24 weeks. The study team will perform an interim evaluation of data and safety at the end of 12 weeks of treatment.
Phase 2 Arm A (N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
Phase 2 Arm B (N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).

Participant Flow:   Overall Study
    Phase 1     Phase 2 Arm A     Phase 2 Arm B  
STARTED     10     25     25  
COMPLETED     9     24     22  
NOT COMPLETED     1     1     3  
Lost to Follow-up                 1                 1                 1  
Discontinued                 0                 0                 2  



  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.
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Reporting Groups
  Description
Phase 1 (N =10): Participants will be enrolled and will receive GS-7977 QD in combination with RBV for a total of 24 weeks. The study team will perform an interim evaluation of data and safety at the end of 12 weeks of treatment.
Phase 2 Arm A (N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
Phase 2 Arm B (N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
Total Total of all reporting groups

Baseline Measures
    Phase 1     Phase 2 Arm A     Phase 2 Arm B     Total  
Number of Participants  
[units: participants]
  10     25     25     60  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     10     25     25     60  
>=65 years     0     0     0     0  
Gender  
[units: participants]
       
Female     6     6     11     23  
Male     4     19     14     37  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     9     18     23     50  
White     1     6     2     9  
More than one race     0     1     0     1  
Unknown or Not Reported     0     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     0     2     0     2  
Not Hispanic or Latino     10     23     25     58  
Unknown or Not Reported     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     10     25     25     60  



  Outcome Measures
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1.  Primary:   Participants With Adverse Events   [ Time Frame: 24 weeks ]

2.  Primary:   Sustained Virologic Response   [ Time Frame: 24 weeks post treatment completion ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Shyam Kottilil
Organization: NIAID/NIH
phone: 301-435-0936
e-mail: skottilil@niaid.nih.gov


Publications:
Publications automatically indexed to this study:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT01441180     History of Changes
Other Study ID Numbers: 110258, 11-I-0258
Study First Received: September 24, 2011
Results First Received: April 23, 2014
Last Updated: September 25, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration