Standard of Care (SOC) With or Without CTS-1027 in Hepatitis C (HCV) Null-Responders

This study has been terminated.
(Risk-benefit ratio)
Sponsor:
Information provided by (Responsible Party):
Conatus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01273064
First received: December 21, 2010
Last updated: June 4, 2012
Last verified: June 2012
Results First Received: March 29, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hepatitis C
Interventions: Drug: CTS-1027
Drug: pegylated interferon
Drug: Ribavirin
Drug: Placebo

  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
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
CTS-1027 60 mg + Ribavirin + Peglyated Interferon Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
CTS-1027 30 mg + Ribavirin + Pegylated Interferon Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
CTS-1027 15 mg + Ribavirin + Pegylated Interferon Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
Placebo + Ribavirin + Pegylated Interferon Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12

Participant Flow:   Overall Study
    CTS-1027 60 mg + Ribavirin + Peglyated Interferon     CTS-1027 30 mg + Ribavirin + Pegylated Interferon     CTS-1027 15 mg + Ribavirin + Pegylated Interferon     Placebo + Ribavirin + Pegylated Interferon     Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon  
STARTED     23     30     31     20     10 [1]
COMPLETED     0     0     0     0     0  
NOT COMPLETED     23     30     31     20     10  
Adverse Event                 5                 1                 3                 2                 1  
Withdrawal by Subject                 4                 2                 2                 2                 0  
Study Termination                 13                 27                 26                 16                 8  
Lost to Follow-up                 1                 0                 0                 0                 0  
Physician Decision                 0                 0                 0                 0                 1  
[1] Began study on the placebo arm, and crossed over to CTS-1027 15 mg at Wk 12 due to lack of response



  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
CTS-1027 60 mg + Ribavirin + Peglyated Interferon Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
CTS-1027 30 mg + Ribavirin + Pegylated Interferon Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
CTS-1027 15 mg + Ribavirin + Pegylated Interferon Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
Placebo + Ribavirin + Pegylated Interferon Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
Total Total of all reporting groups

Baseline Measures
    CTS-1027 60 mg + Ribavirin + Peglyated Interferon     CTS-1027 30 mg + Ribavirin + Pegylated Interferon     CTS-1027 15 mg + Ribavirin + Pegylated Interferon     Placebo + Ribavirin + Pegylated Interferon     Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon     Total  
Number of Participants  
[units: participants]
  23     30     31     20     10     114  
Age  
[units: participants]
           
<=18 years     0     0     0     0     0     0  
Between 18 and 65 years     23     29     28     20     8     108  
>=65 years     0     1     3     0     2     6  
Age  
[units: years]
Mean ± Standard Deviation
  53.1  ± 7.0     55.1  ± 6.0     50.5  ± 11.3     52.8  ± 7.1     57.7  ± 5.9     53.2  ± 8.3  
Gender  
[units: participants]
           
Female     10     10     12     6     3     41  
Male     13     20     19     14     7     73  
Region of Enrollment  
[units: participants]
           
United States     23     30     31     20     10     114  



  Outcome Measures
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1.  Primary:   Sustained Virologic Response   [ Time Frame: Baseline and 24 weeks after the end of treatment (Week 72) ]

2.  Secondary:   Greater Than 2 Log Decline in HCV-RNA at Study Weeks 12, 24 and 48   [ Time Frame: Baseline, and Study Weeks 12, 24, and 48 ]


  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
This study was terminated early after 3 reports of hyperbilirubinemia occurred(2 on 60mg bid and 1 on 30mg bid of CTS 1027). Two incidents were reported as part of an SAE. The risk/benefit ratio did not warrant further continuation of the study.


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: MiRa Huyghe, Vice President, Clinical Development
Organization: Conatus Pharmaceuticals Inc.
phone: (858) 457-7227
e-mail: mhuyghe@conatuspharma.com


No publications provided


Responsible Party: Conatus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01273064     History of Changes
Other Study ID Numbers: CTS-1027-05
Study First Received: December 21, 2010
Results First Received: March 29, 2012
Last Updated: June 4, 2012
Health Authority: United States: Food and Drug Administration