Trial record 1 of 1 for:    NCT00938860
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Sustained Virological Response (SVR) to Antiviral Treatment of Liver Transplant Recipients With Recurrent Hepatitis C (SUSTAIN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00938860
First received: July 13, 2009
Last updated: August 12, 2014
Last verified: August 2014
Results First Received: April 25, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hepatitis C
Liver Transplantation
Interventions: Drug: cyclosporin (Neoral)
Drug: tacrolimus

  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
This was an 80 week multicenter randomized, open label, controlled study in adult HCVpositive maintenance liver transplant recipients. Patients were randomized at a 1.3:1 ratio to CsA and tacrolimus. Patients randomized to tacrolimus were maintained on treatment with tacrolimus, patients randomized to CsA were converted from tacrolimus to CsA

Reporting Groups
  Description
Neoral Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
Tacrolimus Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges

Participant Flow:   Overall Study
    Neoral     Tacrolimus  
STARTED     50 [1]   42  
Efficacy Population     40     41  
COMPLETED     25     25  
NOT COMPLETED     25     17  
Adverse Event                 2                 1  
Abnormal laboratory values                 2                 2  
Withdrawal by Subject                 11                 8  
Lost to Follow-up                 4                 4  
Administration problems                 2                 0  
Death                 1                 1  
Protocol Violation                 3                 1  
[1] Intent-to-Treat (ITT) population. ITT population consisted of all randomized patients



  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.

Intent-to-Treat (ITT) population:

The ITT population consisted of all randomized patients.


Reporting Groups
  Description
Neoral Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
Tacrolimus Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
Total Total of all reporting groups

Baseline Measures
    Neoral     Tacrolimus     Total  
Number of Participants  
[units: participants]
  50     42     92  
Age  
[units: Years]
Mean ± Standard Deviation
  54.2  ± 6.30     55.0  ± 6.84     54.6  ± 6.53  
Gender  
[units: Participants]
     
Female     9     8     17  
Male     41     34     75  



  Outcome Measures
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1.  Primary:   Number of Participants Sustained Virological Response (SVR) Following Treatment of Hepatitis C Virus (HCV) Infection With Peg-IFN and Ribavirin in Liver Transplanted Recipients on Maintenance Therapy With Neoral or Tacrolimus   [ Time Frame: Week 24 ]

2.  Secondary:   Number of Events of the Composite Endpoint of Biopsy Proven Acute Rejections (BPAR), Death or Graft Loss and of the Individual Components   [ Time Frame: Week 80 ]

3.  Secondary:   Number of Participants With Fibrosis Progression (Increase in Ishak-Knodell (IK) Score by at Least One Point From the Baseline)   [ Time Frame: Week 80 ]

4.  Secondary:   Number of Participants of Rapid Viral Response (RVR)   [ Time Frame: Week 4 ]

5.  Secondary:   Number of Participants of Early Viral Response (EVR)   [ Time Frame: Week 12 ]

6.  Secondary:   Number of Participants for the End of Treatment Response (ETR)   [ Time Frame: Week 80 ]

7.  Secondary:   Number of Participants of True Non-responder Rate   [ Time Frame: Week 80 ]

8.  Secondary:   Number of Participants for Relapse Rate   [ Time Frame: Week 24 ]

9.  Secondary:   Number of Participants With Dose Reduction or Discontinuation of Antiviral (AV) Therapy Due to Poor Tolerability at Any Time During the Study for Any Reason   [ Time Frame: Week 80 ]


  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: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300
e-mail: trialandresults.registries@novartis.com


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00938860     History of Changes
Other Study ID Numbers: COLO400A2430, 2009-010806-12
Study First Received: July 13, 2009
Results First Received: April 25, 2014
Last Updated: August 12, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: Ministry of Health
Canada: Health Canada
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
France: Ministry of Health
Germany: Ministry of Health
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Korea: Food and Drug Administration
Romania: Ministry of Public Health
Russia: Ministry of Health of the Russian Federation
Spain: Ministry of Health
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency