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Trial of Growth Hormone Therapy in Pediatric Crohn's Disease

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00109473
First received: April 28, 2005
Last updated: October 10, 2011
Last verified: October 2011
History of Changes
Results First Received: June 24, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Crohn's Disease
Interventions: Drug: growth hormone
Drug: cortecosteroid

  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
98 subjects were assessed for eligibility, 76 did not meet inclusion criteria, 21 refused to participate

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
21 subjects enrolled, one withdrew consent prior to randomization.

Reporting Groups
  Description
Growth Hormone Plus Corticosteroid (CTX) Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
Corticosteroid (CTX) Subjects took corticosteroid as prescribed by their physician

Participant Flow for 3 periods

 Period 1:   Baseline (0 Through 12 Weeks)
    Growth Hormone Plus Corticosteroid (CTX)     Corticosteroid (CTX)  
STARTED     10 [1]   10  
Analyzed     10     10  
COMPLETED     10     9 [2]
NOT COMPLETED     0     1  
[1] 11 subjects allocated to Group A; one withdrew consent, only 10 receieved intervention.
[2] One subject discontinued intervention because of active disease requiring imfliximab

Period 2:   Week 12 to Week 24
    Growth Hormone Plus Corticosteroid (CTX)     Corticosteroid (CTX)  
STARTED     10     9  
Analyzed     9     9  
COMPLETED     9 [1]   9 [2]
NOT COMPLETED     1     0  
[1] One subject withdrew consent
[2] one subject discontinued intervention due to active disease requiring surgery

Period 3:   52 Week Extension Phase
    Growth Hormone Plus Corticosteroid (CTX)     Corticosteroid (CTX)  
STARTED     9     8  
Analyzed     9     8  
COMPLETED     5 [1]   3 [1]
NOT COMPLETED     4     5  
[1] Extension phase ends when subjects discontinue intervention due to active disease or reaches week 64



  Baseline Characteristics
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Reporting Groups
  Description
Growth Hormone Plus Corticosteroid (CTX) Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
Corticosteroid (CTX) Subjects took corticosteroid as prescribed by their physician
Total Total of all reporting groups

Baseline Measures
    Growth Hormone Plus Corticosteroid (CTX)     Corticosteroid (CTX)     Total  
Number of Participants  
[units: participants]
 		  10     10     20  
Age  
[units: participants]
 		     
<=18 years     10     10     20  
Age  
[units: years]
Mean ± Standard Deviation 		  12  ± 3     13  ± 3     13  ± 3  
Gender  
[units: participants]
 		     
Female     2     2     4  
Male     8     8     16  
Region of Enrollment  
[units: participants]
 		     
United States     10     10     20  



  Outcome Measures
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1.  Primary:   Crohn's Disease Histologic Index of Severity (CDHIS)   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Serum IGF-1 (Insulin-like Growth Factor 1)z Score   [ Time Frame: Baseline, 12 weeks, 24 weeks ]
  Show Outcome Measure 2

3.  Secondary:   IMPACT III Score   [ Time Frame: Baseline, 12 weeks, 24 weeks ]
  Show Outcome Measure 3

4.  Secondary:   Pediatric Crohn's Disease Activity Index (PCDAI)   [ Time Frame: Baseline, 12 and 24 weeks ]
  Show Outcome Measure 4

5.  Secondary:   Crohn's Disease Endoscopic Index of Severity (CDEIS)   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 5

6.  Secondary:   Height Velocity   [ Time Frame: Baseline, week 12, 24 and 48 ]
  Hide Outcome Measure 6

Measure Type Secondary
Measure Title Height Velocity
Measure Description

Height velocity was computed every 12 weeks up to week 64 and then yearly during the Maintenance study. Since 40 to 80% of children with Crohn's disease have significant growth failure at diagnosis, height velocity is used to track for changes in height.

It is calculated by measuring height at two points of time and then dividing the change by the amount of time.
Time Frame Baseline, week 12, 24 and 48  
Safety Issue No  

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
Growth Hormone Plus Corticosteroid (CTX) Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
Corticosteroid (CTX) Subjects took corticosteroid as prescribed by their physician

Measured Values
    Growth Hormone Plus Corticosteroid (CTX)     Corticosteroid (CTX)  
Number of Participants Analyzed  
[units: participants]
 		  10     10  
Height Velocity  
[units: cm/year]
Mean ± Standard Error 		   
Baseline     5  ± 1     3  ± 1  
Week 12     8  ± 1     3  ± 1  
Week 24     9  ± 1     7  ± 1  

No statistical analysis provided for Height Velocity



7.  Secondary:   Fecal Calprotectin   [ Time Frame: At 24 and 64 weeks ]
  Show Outcome Measure 7

8.  Secondary:   Total Corticosteroid Use   [ Time Frame: 12 weeks, 24 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Lee A. Denson
Organization: Cincinnati Children's Hospital Medical Center
phone: 513-636-7575
e-mail: lee.denson@cchmc.org


No publications provided


Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00109473     History of Changes
Other Study ID Numbers: CCHMC IRB #: 04-12-06, IND # 71,344
Study First Received: April 28, 2005
Results First Received: June 24, 2011
Last Updated: October 10, 2011
Health Authority: United States: Food and Drug Administration