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Study of SCY-635, Pegasys and Copegus in Hepatitis C

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01265511
First Posted: December 23, 2010
Last Update Posted: August 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Scynexis, Inc.
Results First Submitted: October 22, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hepatitis C Infection
Interventions: Drug: Placebo
Drug: SCY-635
Drug: Pegasys
Drug: Copegus

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo

Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks

Placebo: Oral tablets given bid for 28 days

peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks

Ribavirin: tablets given bid for up to 48 weeks

SCY-635 600 mg

SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks

SCY-635: SCY-635 tablets, 300 mg bid for 28 days

peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks

Ribavirin: tablets given bid for up to 48 weeks


Participant Flow:   Overall Study
    Placebo   SCY-635 600 mg
STARTED   2   8 
COMPLETED   0   5 
NOT COMPLETED   2   3 
Lack of Efficacy                2                1 
Met stopping rules                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.
No text entered.

Reporting Groups
  Description
Placebo

Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks

Placebo: Oral tablets given bid for 28 days

peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks

Ribavirin: tablets given bid for up to 48 weeks

SCY-635 600 mg

SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks

SCY-635: SCY-635 tablets, 300 mg bid for 28 days

peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks

Ribavirin: tablets given bid for up to 48 weeks

Total Total of all reporting groups

Baseline Measures
   Placebo   SCY-635 600 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 2   8   10 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.0  (15.56)   44.6  (8.67)   45.1  (9.29) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      2  25.0%      2  20.0% 
Male      2 100.0%      6  75.0%      8  80.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1  50.0%      0   0.0%      1  10.0% 
White      1  50.0%      7  87.5%      8  80.0% 
More than one race      0   0.0%      1  12.5%      1  10.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   1   4   5 
Puerto Rico   1   4   5 
IL28B genotype 
[Units: Participants]
     
IL28B_CT   2   6   8 
IL28B_TT   0   2   2 
HCV genotype 
[Units: Participants]
     
HCV_1a   1   7   8 
HCV_1b   1   1   2 
HCV RNA 
[Units: Log10 IU/mL]
Mean (Standard Deviation)
 7.21  (0.05)   6.3  (0.49)   6.48  (0.58) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Undetectable HCV RNA   [ Time Frame: Week 4 ]

2.  Secondary:   Undetectable HCV RNA   [ Time Frame: Week 12 ]

3.  Secondary:   Partial Early Virologic Response   [ Time Frame: Week 12 ]

4.  Secondary:   Undetectable HCV RNA   [ Time Frame: Week 24 ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Katyna Borroto-Esoda
Organization: Scynexis
phone: 9192374431
e-mail: katyna.borroto-esoda@scynexis.com



Responsible Party: Scynexis, Inc.
ClinicalTrials.gov Identifier: NCT01265511     History of Changes
Other Study ID Numbers: SCY-635-201
First Submitted: November 23, 2010
First Posted: December 23, 2010
Results First Submitted: October 22, 2014
Results First Posted: August 18, 2017
Last Update Posted: August 18, 2017