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Withdrawal of Immunosuppression in Pediatric Liver Transplant Recipients (WISP-R)

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ClinicalTrials.gov Identifier: NCT00320606
Recruitment Status : Completed
First Posted : May 3, 2006
Results First Posted : July 6, 2011
Last Update Posted : September 20, 2018
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Liver Transplant
Liver Transplantation
Intervention Drug: Immunosuppression Withdrawal
Enrollment 20
Recruitment Details Three centers in the United States enrolled 20 pediatric recipients of parental living-donor liver allografts between June 2006 and August 2008.
Pre-assignment Details Informed consent was obtained from eligible individuals prior to screening assessments. Participants then underwent procedures at screening to determine eligibility according to the study's inclusion/exclusion criteria.
Arm/Group Title Immunosuppression Withdrawal Arm
Hide Arm/Group Description Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Period Title: Overall Study
Started 20
Completed 17
Not Completed 3
Reason Not Completed
Adverse Event             1
Protocol Violation             1
Withdrawal by Subject             1
Arm/Group Title Immunosuppression Withdrawal Arm
Hide Arm/Group Description Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
Intent-to-treat
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
20
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
8.7  (2.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
9
  45.0%
Male
11
  55.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
4
  20.0%
Not Hispanic or Latino
16
  80.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
20
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
 100.0%
Baseline Glomerular Filtration Rate (GFR)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  mL/min/1.73 m^2
Number Analyzed 20 participants
113.2
(93.40 to 121.13)
[1]
Measure Description: Glomerular filtration rate (GFR) is a measure of kidney function. The bedside Schwartz equation was used to estimate GFR from serum creatinine and height in children. Baseline serum creatinine was utilized in this equation, defined as the creatinine value at the start of immunosuppressive (IS) treatment tapering. Baseline height was utilized in the equation, defined as the last height recorded prior to the start of IS treatment tapering. Estimate of normal GFR: ≥90 mL/min per 1.73 m^2.
Baseline Total Cholesterol   [1] 
Median (Inter-Quartile Range)
Unit of measure:  mg/dL
Number Analyzed 20 participants
147
(132 to 162)
[1]
Measure Description:

Total serum cholesterol collected at the start of IS tapering.

Target range for total cholesterol: 75-169 mg/dL if age ≤20; high values indicate risk of cardiovascular disease

Baseline Glucose   [1] 
Median (Inter-Quartile Range)
Unit of measure:  mg/dL
Number Analyzed 20 participants
89.5
(84.0 to 94.0)
[1]
Measure Description:

Glucose collected at the start of tapering. This is a measure of glucose found in the blood. Glucose, a sugar, is an energy source that the body relies on to properly function. If levels are too high for a long period of time, diabetes can develop. Diabetes can result in many long-term complications such as eye, kidney, and nerve damage, stroke, and cardiovascular complications.

Target range for fasting glucose: 60-106 mg/dL.

Baseline Systolic Blood Pressure   [1] 
Median (Inter-Quartile Range)
Unit of measure:  mmHg
Number Analyzed 20 participants
109.5
(100.0 to 117.5)
[1]
Measure Description: Systolic blood pressure measured at the start of IS tapering. Systolic blood pressure measures the pressure on the blood vessels when the heart beats and thus is pushing blood to the rest of the body. For pediatric participants, normal systolic blood pressure is defined as being below the 90th percentile for the participant’s age, sex, and height on at least 3 separate occasions. High blood pressure, also known as hypertension, is a risk factor for coronary artery disease, stroke, heart failure, and other complications if left unmanaged.
Baseline Diastolic Blood Pressure   [1] 
Median (Inter-Quartile Range)
Unit of measure:  mmHg
Number Analyzed 20 participants
64.5
(58.0 to 73.5)
[1]
Measure Description: Diastolic blood pressure measured at the start of IS tapering. Diastolic blood pressure measures the pressure in the arteries when the heart is a rest and is thus filled with blood. For pediatric participants, normal systolic blood pressure is defined as being below the 90th percentile for the participant’s age, sex, and height on at least 3 separate occasions. High blood pressure, also known as hypertension, is a risk factor for coronary artery disease, stroke, heart failure, and other complications if left unmanaged.
1.Primary Outcome
Title Proportion of Participants Successfully Withdrawn From Immunosuppression
Hide Description Participants were considered successfully withdrawn from immunosuppression if they remained off immunosuppression for at least one year with normal allograft function.
Time Frame 1 year after completion of immunosuppression withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat
Arm/Group Title Immunosuppression Withdrawal Arm
Hide Arm/Group Description:
Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Proportion of participants
0.60
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immunosuppression Withdrawal Arm
Comments The proportion of participants in whom immunosuppression withdrawal was attempted who are successfully withdrawn from immunosuppression are descriptively summarized with 95% confidence intervals using an exact binomial method
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter 95% confidence interval using an exact b
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.4 to 0.8
Estimation Comments Proportion Success
2.Secondary Outcome
Title Number of Participants Who Suffered Graft Loss or Died Following Initiation of Immunosuppression Withdrawal
Hide Description Participants who died while on the study for any reason as well as participants that experienced the loss of their transplant while a participant in the study.
Time Frame Enrollment through end of study (up to 9.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat
Arm/Group Title Immunosuppression Withdrawal Arm
Hide Arm/Group Description:
Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immunosuppression Withdrawal Arm
Comments The proportion of participants in whom immunosuppression (IS) withdrawal was attempted who are successfully withdrawn from immunosuppression and experience death or graft loss are descriptively summarized with 95% confidence intervals using an exact binomial method.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Binomial Proportion
Estimated Value 0
Confidence Interval (2-Sided) 95%
0.0 to 0.1684
Estimation Comments 95% Confidence Interval Exact Binomial
3.Secondary Outcome
Title Time From Start of Immunosuppression Withdrawal to the First Episode of Acute Rejection, Second Episode of Rejection That Did Not Require Treatment, or to Diagnosis of Chronic Rejection
Hide Description The number of days between the start of immunosuppression (IS) withdrawal and the first episode of acute rejection (either clinical rejection or based on BANFF criteria), second episode of rejection that did not require treatment, or the first diagnosis of chronic rejection.
Time Frame From the start of immunosuppression withdrawal to first acute rejection, second episode of rejection that did not require treatment, or diagnosis of chronic rejection through end of study (up to 9.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat participants who experienced acute rejection or were diagnosed with chronic rejection.
Arm/Group Title Immunosuppression Withdrawal Arm
Hide Arm/Group Description:
Participants were gradually tapered off of their single immunosuppression drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Overall Number of Participants Analyzed 7
Mean (95% Confidence Interval)
Unit of Measure: Days
211.57
(113.56 to 309.58)
4.Secondary Outcome
Title Immunosuppression-Free Duration
Hide Description The number of months between the end of immunosuppression withdrawal and either the end of trial participation or the time of restarting immunosuppression
Time Frame Completion of Withdrawal to either end of trial participation (up to 9.5 years) or time to restarting immunosuppression
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat participants who completed withdrawal
Arm/Group Title Immunosuppression Withdrawal Arm
Hide Arm/Group Description:
Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Overall Number of Participants Analyzed 15
Mean (95% Confidence Interval)
Unit of Measure: Months
75.84
(53.28 to 98.39)
5.Secondary Outcome
Title Distribution of Histologic Severity Among Rejection Episodes
Hide Description The number of participants within each level of histologic severity based on BANFF grading criteria (Mild, Moderate, Severe).
Time Frame Start of immunosuppressive withdrawal to rejection through end of study (up to 9.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-treat group who experienced a biopsy-proven rejection episode
Arm/Group Title Immunosuppression Withdrawal Arm
Hide Arm/Group Description:
Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: Biopsy Proven rejection episodes
Mild 3
Moderate 2
Severe 0
6.Secondary Outcome
Title Number of Participants Experiencing Adverse Events by Severity
Hide Description The results provide the total number of participants experiencing adverse events (AEs). Participants experiencing AEs are stratified into five severity categories: mild, moderate, severe, life-threatening, and death, based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Time Frame Enrollment through end of study (up to 9.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat
Arm/Group Title Immunosuppression Withdrawal Arm
Hide Arm/Group Description:
Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
Total Adverse Events
19
  95.0%
Mild
18
  90.0%
Moderate
17
  85.0%
Severe
6
  30.0%
Life Threatening
0
   0.0%
Death
0
   0.0%
7.Secondary Outcome
Title Percent Change From Baseline in Renal Function Measured by the Glomerular Filtration Rate (GFR)
Hide Description Percent change from baseline at each annual visit. The bedside Schwartz equation was used to estimate GFR from serum creatinine and height in children. Baseline serum creatinine was utilized in the equation, defined as the creatinine value at the start of IS tapering. Baseline height was utilized in the equation, defined as the last height recorded prior to the start of IS tapering. Serum creatinine measurements and height measurements at the annual visits were used to calculate the annual GFR. When height value was not available, the height collected prior to the annual visit was used in the GFR calculation. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits.
Time Frame Enrollment through end of study (up to 9.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat with GFR data at visits available for analysis
Arm/Group Title Immunosuppression Withdrawal Arm
Hide Arm/Group Description:
Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Overall Number of Participants Analyzed 18
Median (Inter-Quartile Range)
Unit of Measure: Percent change
Percent Change in GFR at Month 12 Number Analyzed 9 participants
4.5
(2.41 to 22.42)
Percent Change in GFR at M12 Visit Number Analyzed 18 participants
8.7
(3.89 to 28.05)
Percent Change in GFR at M24 Visit Number Analyzed 12 participants
20.5
(5.46 to 48.40)
Percent Change in GFR at L12 Visit Number Analyzed 12 participants
10.8
(-1.71 to 34.89)
Percent Change in GFR at L24 Visit Number Analyzed 11 participants
7.3
(-7.86 to 38.84)
Percent Change in GFR at E12 Visit Number Analyzed 11 participants
-3.9
(-9.97 to 31.52)
Percent Change in GFR at E24 Visit Number Analyzed 11 participants
-6.3
(-22.18 to 23.66)
Percent Change in GFR at E36 Visit Number Analyzed 11 participants
-5.1
(-15.76 to 15.20)
Percent Change in GFR at E48 Visit Number Analyzed 11 participants
-15.1
(-23.38 to 2.13)
8.Secondary Outcome
Title Percent Change From Baseline in Total Cholesterol
Hide Description Percent change from baseline in total serum cholesterol. Cholesterol is a waxy substance your body needs to build cells, but too much can be a problem since it can build-up in arteries. Narrowed arteries can result in heart attack or stroke. This outcome looks at the percent change from baseline (cholesterol level at the start of IS tapering) to each annual visit. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits.
Time Frame Enrollment through end of study (up to 9.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat with cholesterol data available at visit
Arm/Group Title Immunosuppression Withdrawal Arm
Hide Arm/Group Description:
Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Overall Number of Participants Analyzed 13
Median (Inter-Quartile Range)
Unit of Measure: Percent change
Percent Change in Cholesterol at Month 12 Number Analyzed 6 participants
-7.9
(-16.23 to -5.33)
Percent Change in Cholesterol at M12 Visit Number Analyzed 13 participants
-0.6
(-9.74 to 4.07)
Percent Change in Cholesterol at M24 Visit Number Analyzed 10 participants
-10.9
(-14.21 to -5.92)
Percent Change in Cholesterol at L12 Visit Number Analyzed 11 participants
-3.0
(-16.67 to 1.26)
Percent Change in Cholesterol at L24 Visit Number Analyzed 10 participants
-10.7
(-18.37 to -7.10)
Percent Change in Cholesterol at E12 Visit Number Analyzed 10 participants
-9.0
(-15.38 to 0.94)
Percent Change in Cholesterol at E24 Visit Number Analyzed 9 participants
-11.2
(-15.38 to -5.66)
Percent Change in Cholesterol at E36 Visit Number Analyzed 8 participants
-6.9
(-19.00 to 6.78)
Percent Change in Cholesterol at E48 Visit Number Analyzed 8 participants
-10.9
(-14.51 to 10.36)
9.Secondary Outcome
Title Percent Change From Baseline in Blood Glucose
Hide Description Glucose, a sugar, is an energy source that the body relies on to properly function. If levels are too high for a long period of time, diabetes can develop. Diabetes can result in many long-term complications such as eye, kidney, and nerve damage, stroke, and cardiovascular complications. The outcome looks at the percent change from baseline (glucose level at the start of tapering) to each annual visit. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits.
Time Frame Enrollment through end of study (up to 9.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat with glucose data available at visit
Arm/Group Title Immunosuppression Withdrawal Arm
Hide Arm/Group Description:
Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Overall Number of Participants Analyzed 17
Median (Inter-Quartile Range)
Unit of Measure: Percent change
Percent Change in Glucose at Month 12 Number Analyzed 9 participants
-2.2
(-4.44 to 10.87)
Percent Change in Glucose at M12 Visit Number Analyzed 17 participants
1.0
(-6.32 to 13.41)
Percent Change in Glucose at M24 Visit Number Analyzed 12 participants
1.8
(-5.47 to 9.41)
Percent Change in Glucose at L12 Visit Number Analyzed 12 participants
-0.5
(-5.42 to 9.09)
Percent Change in Glucose at L24 Visit Number Analyzed 11 participants
2.0
(0.00 to 15.22)
Percent Change in Glucose at E12 Visit Number Analyzed 11 participants
-3.3
(-7.53 to 8.99)
Percent Change in Glucose at E24 Visit Number Analyzed 11 participants
-1.1
(-6.45 to 4.82)
Percent Change in Glucose at E36 Visit Number Analyzed 11 participants
5.6
(-5.32 to 13.98)
Percent Change in Glucose at E48 Visit Number Analyzed 11 participants
-5.3
(-10.64 to 4.49)
10.Secondary Outcome
Title Percent Change From Baseline in Systolic Blood Pressure
Hide Description Systolic blood pressure (BP) measures the pressure on the blood vessels when the heart is beats and thus is pushing blood to the rest of the body. This outcome assesses the percent change from baseline (systolic blood pressure measurement at the start of tapering) to each annual visit. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits.
Time Frame Enrollment through end of study (up to 9.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat with systolic blood pressure data available at visit
Arm/Group Title Immunosuppression Withdrawal Arm
Hide Arm/Group Description:
Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Overall Number of Participants Analyzed 17
Median (Inter-Quartile Range)
Unit of Measure: Percent change
Percent Change in Systolic BP at Month 12 Number Analyzed 10 participants
2.0
(-9.65 to 6.32)
Percent Change in Systolic BP at M12 Visit Number Analyzed 17 participants
0.0
(-9.65 to 5.83)
Percent Change in Systolic BP at M24 Number Analyzed 12 participants
4.3
(-2.87 to 10.66)
Percent Change in Systolic BP at L12 Visit Number Analyzed 12 participants
3.8
(-5.05 to 10.08)
Percent Change in Systolic BP at L24 Visit Number Analyzed 11 participants
8.6
(2.68 to 20.41)
Percent Change in Systolic BP at E12 Visit Number Analyzed 11 participants
2.8
(-4.46 to 14.53)
Percent Change in Systolic BP at E24 Visit Number Analyzed 11 participants
5.1
(-3.23 to 11.67)
Percent Change in Systolic BP at E36 Visit Number Analyzed 11 participants
9.2
(0.92 to 12.82)
Percent Change in Systolic BP at E48 Visit Number Analyzed 11 participants
2.7
(-4.17 to 13.76)
11.Secondary Outcome
Title Percent Change From Baseline in Diastolic Blood Pressure
Hide Description Diastolic blood pressure (BP) measures the pressure in the arteries when the heart is a rest and is thus filled with blood. This outcome assesses the percent change from baseline (diastolic blood pressure measurement at the start of IS tapering) to each annual visit. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits.
Time Frame Enrollment through end of study (up to 9.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat with diastolic blood pressure data available at visit
Arm/Group Title Immunosuppression Withdrawal Arm
Hide Arm/Group Description:
Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Overall Number of Participants Analyzed 17
Median (Inter-Quartile Range)
Unit of Measure: Percent change
Percent Change in Diastolic BP at Month 12 Number Analyzed 10 participants
-7.5
(-15.38 to 7.41)
Percent Change in Diastolic BP atM12 Visit Number Analyzed 17 participants
0.0
(-8.22 to 2.70)
Percent Change in Diastolic BP at M24 Visit Number Analyzed 12 participants
-5.4
(-16.41 to 11.92)
Percent Change in Diastolic BP at L12 Visit Number Analyzed 12 participants
1.5
(-12.41 to 4.73)
Percent Change in Diastolic BP at L24 Visit Number Analyzed 11 participants
6.6
(-9.59 to 7.59)
Percent Change in Diastolic BP at E12 Visit Number Analyzed 11 participants
0.0
(-7.14 to 6.06)
Percent Change in Diastolic BP at E24 Visit Number Analyzed 11 participants
2.6
(-5.33 to 4.55)
Percent Change in Diastolic BP at E36 Visit Number Analyzed 11 participants
-1.4
(-8.22 to 6.58)
Percent Change in Diastolic BP at E48 Number Analyzed 11 participants
9.1
(-7.89 to 11.11)
Time Frame Enrollment through end of study (up to 9.5 years)
Adverse Event Reporting Description Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
 
Arm/Group Title Immunosuppression Withdrawal Arm
Hide Arm/Group Description Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
All-Cause Mortality
Immunosuppression Withdrawal Arm
Affected / at Risk (%)
Total   0/20 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Immunosuppression Withdrawal Arm
Affected / at Risk (%) # Events
Total   13/20 (65.00%)    
Gastrointestinal disorders   
Abdominal pain  1  2/20 (10.00%)  2
Vomiting  1  1/20 (5.00%)  1
Hepatobiliary disorders   
Bile duct obstruction  1  1/20 (5.00%)  3
Bile duct stenosis  1  3/20 (15.00%)  5
Cholangitis  1  1/20 (5.00%)  2
Cholangitis acute  1  1/20 (5.00%)  1
Cholelithiasis  1  1/20 (5.00%)  1
Hepatitis  1  1/20 (5.00%)  1
Portal vein stenosis  1  1/20 (5.00%)  1
Immune system disorders   
Transplant rejection  1  5/20 (25.00%)  5
Infections and infestations   
Enterococcal bacteraemia  1  1/20 (5.00%)  1
Gastritis viral  1  1/20 (5.00%)  1
Influenza  1  1/20 (5.00%)  1
Klebsiella infection  1  1/20 (5.00%)  1
Investigations   
Liver function test abnormal  1  3/20 (15.00%)  3
Respiratory, thoracic and mediastinal disorders   
Diaphragmatic hernia  1  1/20 (5.00%)  1
Surgical and medical procedures   
Ventricular septal defect repair  1  1/20 (5.00%)  1
1
Term from vocabulary, MedDRA 11.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Immunosuppression Withdrawal Arm
Affected / at Risk (%) # Events
Total   19/20 (95.00%)    
Blood and lymphatic system disorders   
Splenomegaly  1  1/20 (5.00%)  1
Ear and labyrinth disorders   
Cerumen impaction  1  1/20 (5.00%)  1
Ear pain  1  1/20 (5.00%)  1
Eye disorders   
Conjunctivitis  1  1/20 (5.00%)  1
Gastrointestinal disorders   
Abdominal pain  1  1/20 (5.00%)  1
Abdominal pain upper  1  2/20 (10.00%)  3
Constipation  1  5/20 (25.00%)  6
Diarrhoea  1  1/20 (5.00%)  2
Mouth ulceration  1  2/20 (10.00%)  2
Vomiting  1  3/20 (15.00%)  4
General disorders   
Influenza like illness  1  9/20 (45.00%)  35
Pyrexia  1  4/20 (20.00%)  5
Hepatobiliary disorders   
Bile duct stenosis  1  1/20 (5.00%)  1
Cholangitis  1  2/20 (10.00%)  3
Immune system disorders   
Immunisation reaction  1  1/20 (5.00%)  1
Infections and infestations   
Bronchitis  1  2/20 (10.00%)  3
Ear infection  1  3/20 (15.00%)  3
Fungal skin infection  1  1/20 (5.00%)  1
Gastroenteritis  1  1/20 (5.00%)  1
Impetigo  1  1/20 (5.00%)  1
Influenza  1  2/20 (10.00%)  3
Nasopharyngitis  1  2/20 (10.00%)  5
Oral herpes  1  1/20 (5.00%)  1
Pertussis  1  2/20 (10.00%)  2
Pharyngitis streptococcal  1  2/20 (10.00%)  2
Pneumonia  1  1/20 (5.00%)  1
Rhinitis  1  1/20 (5.00%)  1
Sinusitis  1  6/20 (30.00%)  9
Streptococcal infection  1  1/20 (5.00%)  1
Tonsillitis  1  1/20 (5.00%)  1
Upper respiratory tract infection  1  4/20 (20.00%)  4
Urinary tract infection  1  2/20 (10.00%)  2
Varicella  1  1/20 (5.00%)  1
Vulvovaginal mycotic infection  1  1/20 (5.00%)  1
Wound infection  1  1/20 (5.00%)  1
Injury, poisoning and procedural complications   
Animal bite  1  1/20 (5.00%)  1
Arthropod bite  1  2/20 (10.00%)  3
Concussion  1  1/20 (5.00%)  1
Graft dysfunction  1  1/20 (5.00%)  2
Mouth injury  1  1/20 (5.00%)  1
Muscle strain  1  1/20 (5.00%)  1
Suture related complication  1  1/20 (5.00%)  1
Upper limb fracture  1  1/20 (5.00%)  1
Wrist fracture  1  2/20 (10.00%)  2
Investigations   
Alanine aminotransferase increased  1  2/20 (10.00%)  3
Aspartate aminotransferase increased  1  1/20 (5.00%)  1
Blood alkaline phosphatase increased  1  1/20 (5.00%)  3
Blood magnesium decreased  1  1/20 (5.00%)  1
Gamma-glutamyltransferase increased  1  3/20 (15.00%)  3
Hepatic enzyme increased  1  5/20 (25.00%)  10
Liver function test abnormal  1  1/20 (5.00%)  1
Smooth muscle antibody positive  1  1/20 (5.00%)  1
Spleen palpable  1  1/20 (5.00%)  1
Vitamin D decreased  1  1/20 (5.00%)  1
Metabolism and nutrition disorders   
Decreased appetite  1  1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/20 (10.00%)  2
Growing pains  1  1/20 (5.00%)  2
Synovial cyst  1  1/20 (5.00%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Skin papilloma  1  2/20 (10.00%)  2
Nervous system disorders   
Headache  1  4/20 (20.00%)  4
Migraine  1  1/20 (5.00%)  1
Psychiatric disorders   
Anxiety  1  1/20 (5.00%)  1
Depression  1  1/20 (5.00%)  1
Reproductive system and breast disorders   
Dysmenorrhoea  1  2/20 (10.00%)  2
Scrotal varicose veins  1  1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders   
Adenoidal hypertrophy  1  1/20 (5.00%)  1
Cough  1  7/20 (35.00%)  11
Oropharyngeal pain  1  4/20 (20.00%)  6
Pulmonary congestion  1  1/20 (5.00%)  1
Sinus congestion  1  4/20 (20.00%)  6
Tonsillar hypertrophy  1  2/20 (10.00%)  2
Skin and subcutaneous tissue disorders   
Acanthosis nigricans  1  1/20 (5.00%)  1
Acne  1  1/20 (5.00%)  1
Dermal cyst  1  1/20 (5.00%)  1
Dermatitis contact  1  2/20 (10.00%)  3
Dry skin  1  1/20 (5.00%)  1
Eczema  1  2/20 (10.00%)  2
Pruritus  1  1/20 (5.00%)  1
Rash  1  3/20 (15.00%)  4
Urticaria  1  1/20 (5.00%)  1
Vascular disorders   
Hypertension  1  1/20 (5.00%)  1
1
Term from vocabulary, MedDRA 11.1
Indicates events were collected by systematic assessment
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 Program
Organization: DAIT/NIAID
Phone: 301-594-7669
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00320606     History of Changes
Other Study ID Numbers: DAIT ITN029ST
First Submitted: April 28, 2006
First Posted: May 3, 2006
Results First Submitted: June 8, 2011
Results First Posted: July 6, 2011
Last Update Posted: September 20, 2018