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Immunosuppression Withdrawal for Stable Pediatric Liver Transplant Recipients (iWITH)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01638559
First received: July 9, 2012
Last updated: May 19, 2017
Last verified: May 2017
Results First Received: May 17, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Liver Transplant Recipients
Liver Transplantation
Immunosuppression
Intervention: Drug: 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
After institutional review board approval and informed consent, 161 subjects were screened and 88 subjects were enrolled. Eleven sites are in the U.S. and 1 site is in Canada. Recruitment was active from August 2012 through April 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants underwent a screening biopsy to assess study eligibility prior to beginning withdrawal of immunosuppression medications.

Reporting Groups
  Description
Participants That Initiated Withdrawal Pediatric liver transplant recipients with stable liver function tests, no evidence of rejection in the past 2 years, and at least 4 years post-transplant underwent gradual Immunosuppression withdrawal in no less than 36 weeks and no more than 52 weeks with frequent monitoring of liver tests. All participants were followed for 48 months ensuring a minimum of 36 months of follow-up after successful Immunosuppression withdrawal.

Participant Flow:   Overall Study
    Participants That Initiated Withdrawal
STARTED   88 
COMPLETED   88 [1] 
NOT COMPLETED   0 
[1] Completion through the time of the primary endpoint.



  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

Reporting Groups
  Description
Participants That Initiated Withdrawal Pediatric liver transplant recipients with stable liver function tests, no evidence of rejection in the past 2 years, and at least 4 years post-transplant underwent gradual Immunosuppression withdrawal in no less than 36 weeks and no more than 52 weeks with frequent monitoring of liver tests. All participants were followed for 48 months ensuring a minimum of 36 months of follow-up after successful Immunosuppression withdrawal.

Baseline Measures
   Participants That Initiated Withdrawal 
Overall Participants Analyzed 
[Units: Participants]
 88 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      88 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 10.4  (3.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      49  55.7% 
Male      39  44.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      12  13.6% 
Not Hispanic or Latino      74  84.1% 
Unknown or Not Reported      2   2.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      4   4.5% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      4   4.5% 
White      76  86.4% 
More than one race      0   0.0% 
Unknown or Not Reported      4   4.5% 
Region of Enrollment 
[Units: Participants]
 
Canada   6 
United States   82 


  Outcome Measures

1.  Primary:   Number of Operationally Tolerant Participants   [ Time Frame: 12 Months after Complete immunosuppression withdrawal ]


  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


Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01638559     History of Changes
Other Study ID Numbers: DAIT iWITH
5U01AI100807-04 ( U.S. NIH Grant/Contract )
RTB-001 ( Other Identifier: DAIT NIAID )
Study First Received: July 9, 2012
Results First Received: May 17, 2017
Last Updated: May 19, 2017