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Gradual Withdrawal of Immune System Suppressing Drugs in Patients Receiving a Liver Transplant (A-WISH)

This study has been completed.
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00135694
First received: August 25, 2005
Last updated: December 8, 2016
Last verified: December 2016
Results First Received: October 13, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hepatitis C
Hepatitis C, Chronic
Nonimmune Nonviral Causes of Liver Failure
Interventions: Drug: calcineurin inhibitor-based immunosuppression
Procedure: liver transplant
Drug: corticosteroids
Other: immunosuppression withdrawal

  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
Participants with liver failure due to hepatitis C infection or non-immune, non-viral causes were enrolled between October 2005 and April 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants 12-24 months post-transplant, stable on immunosuppression monotherapy for at least 3 months prior to random assignment, with stage 2 or less fibrosis on the Ishak scale, adequate hepatic and renal function, and no biopsy-proven rejection were randomized between November 2006 and December 2012.

Reporting Groups
  Description
Terminated Prior to Randomization Subjects enrolled and transplanted into the trial but not eligible for randomization.
Randomized to Immunosuppression Withdrawal Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
Randomized to Immunosuppression Maintenance Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.

Participant Flow:   Overall Study
    Terminated Prior to Randomization   Randomized to Immunosuppression Withdrawal   Randomized to Immunosuppression Maintenance
STARTED   180   77   18 
COMPLETED   0 [1]   56   11 
NOT COMPLETED   180   21   7 
Adverse Event                17                4                0 
Death                14                1                2 
Lost to Follow-up                8                7                1 
Withdrawal by Subject                41                7                4 
Protocol Violation                19                1                0 
Hepatitis C related reasons                39                1                0 
Ineligible for Random assignment                42                0                0 
[1] Subjects were assessed as ineligible for random assignment and subsequently terminated per protocol.



  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.
Enrolled sample (subjects transplanted in the study)

Reporting Groups
  Description
Terminated Prior to Randomization Subjects enrolled and transplanted into the trial but not eligible for randomization.
Randomized to Immunosuppression Withdrawal Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
Randomized to Immunosuppression Maintenance Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
Total Total of all reporting groups

Baseline Measures
   Terminated Prior to Randomization   Randomized to Immunosuppression Withdrawal   Randomized to Immunosuppression Maintenance   Total 
Overall Participants Analyzed 
[Units: Participants]
 180   77   18   275 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      161  89.4%      68  88.3%      13  72.2%      242  88.0% 
>=65 years      19  10.6%      9  11.7%      5  27.8%      33  12.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.5  (7.83)   54.3  (9.92)   57.4  (7.70)   55.3  (8.47) 
Gender 
[Units: Participants]
Count of Participants
       
Female      53  29.4%      14  18.2%      5  27.8%      72  26.2% 
Male      127  70.6%      63  81.8%      13  72.2%      203  73.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      10   5.6%      11  14.3%      3  16.7%      24   8.7% 
Not Hispanic or Latino      167  92.8%      66  85.7%      15  83.3%      248  90.2% 
Unknown or Not Reported      3   1.7%      0   0.0%      0   0.0%      3   1.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      1   0.6%      0   0.0%      0   0.0%      1   0.4% 
Asian      2   1.1%      1   1.3%      1   5.6%      4   1.5% 
Native Hawaiian or Other Pacific Islander      0   0.0%      1   1.3%      0   0.0%      1   0.4% 
Black or African American      22  12.2%      7   9.1%      0   0.0%      29  10.5% 
White      153  85.0%      66  85.7%      17  94.4%      236  85.8% 
More than one race      0   0.0%      1   1.3%      0   0.0%      1   0.4% 
Unknown or Not Reported      2   1.1%      1   1.3%      0   0.0%      3   1.1% 
Region of Enrollment 
[Units: Participants]
       
United States   180   77   18   275 
Serum Creatinine [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 1.5  (1.18)   1.3  (0.65)   1.1  (0.68)   1.4  (1.04) 
[1] The latest creatinine value collected at the screening or baseline visit prior to transplant was used for this measure. The test measures kidney function. According to Harrison's Principles of Internal Medicine, normal results are 0.6 to 1.2 mg/dL for men and 0.5 to 0.9 mg/dL for women. Abnormal kidney function results in increased levels of serum creatinine.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Clinical Complications Usually Attributed to Immunosuppression   [ Time Frame: Randomization to 2 years post-randomization ]

2.  Secondary:   Number of Participants Who Qualify for Random Assignment   [ Time Frame: One to two years post-transplantation ]

3.  Secondary:   Number of Participants Who Successfully Stop Taking Immunosuppression for at Least 6 Months   [ Time Frame: Randomization until study completion or participant termination (up to six years post-transplant) ]

4.  Secondary:   Immunosuppression-free Duration   [ Time Frame: Discontinuation of all immunosuppression to end of trial participation or to time of restarting immunosuppression, whichever came first, assessed up to two years ]

5.  Secondary:   Number of Hepatitis C Infected Participants With Progression of Hepatitis C Related Liver Disease, Defined as Stage 4 or Higher Fibrosis on the Ishak Scale   [ Time Frame: Randomization to 2 years post-randomization. ]

6.  Secondary:   Number of Participants Experiencing Graft Loss or Death   [ Time Frame: Randomization to 2 years post-randomization. ]

7.  Secondary:   Total Immunosuppression From Month 21 to Month 24 Post-randomization   [ Time Frame: Month 21 to Month 24 post-randomization ]

8.  Secondary:   Total Burden of Immunosuppression From Random Assignment to Month 24   [ Time Frame: Randomization to Month 24 post-randomization ]


  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: Director, Clinical Research Operations Program
Organization: DAIT/NIAID
phone: 301-594-7669
e-mail: DAITClinicalTrialsGov@niaid.nih.gov



Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00135694     History of Changes
Other Study ID Numbers: DAIT ITN030ST
Study First Received: August 25, 2005
Results First Received: October 13, 2016
Last Updated: December 8, 2016