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Effect of Increlex® on Children With Crohn Disease

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ClinicalTrials.gov Identifier: NCT00764699
Recruitment Status : Terminated (PI left institution)
First Posted : October 2, 2008
Results First Posted : March 2, 2018
Last Update Posted : March 2, 2018
Sponsor:
Collaborator:
Tercica
Information provided by (Responsible Party):
Nationwide Children's Hospital

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Crohn Disease
Intervention Drug: rhIGF (Increlex)
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title rhIGF
Hide Arm/Group Description

Treatment with rhIGF (Increlex)

rhIGF (Increlex): rhIGF will be administered as a subcutaneous injection per the following schema: First 2 weeks: 40 mcg/kg BID; Weeks 3 and 4: 80 mcg/kg BID; Subsequent weeks: 120 mcg/kg BID.

Period Title: Overall Study
Started 3
Completed 0
Not Completed 3
Reason Not Completed
PI left and study terminated             3
Arm/Group Title rhIGF
Hide Arm/Group Description

Treatment with rhIGF (Increlex)

rhIGF (Increlex): rhIGF will be administered as a subcutaneous injection per the following schema: First 2 weeks: 40 mcg/kg BID; Weeks 3 and 4: 80 mcg/kg BID; Subsequent weeks: 120 mcg/kg BID.

Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
3
 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 3 participants
12.67  (2.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
1
  33.3%
Male
2
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title The Primary Outcome Variable for the Monitoring Study (Baseline, Six Months and Disease Exacerbation) Will be Longitudinal Growth as Measured by Height Velocity
Hide Description [Not Specified]
Time Frame Six months and 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The PI left the institution suddenly and participant records stayed with the institution, so no analysis was able to be performed.
Arm/Group Title rhIGF
Hide Arm/Group Description:

Treatment with rhIGF (Increlex)

rhIGF (Increlex): rhIGF will be administered as a subcutaneous injection per the following schema: First 2 weeks: 40 mcg/kg BID; Weeks 3 and 4: 80 mcg/kg BID; Subsequent weeks: 120 mcg/kg BID.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title rhIGF
Hide Arm/Group Description

Treatment with rhIGF (Increlex)

rhIGF (Increlex): rhIGF will be administered as a subcutaneous injection per the following schema: First 2 weeks: 40 mcg/kg BID; Weeks 3 and 4: 80 mcg/kg BID; Subsequent weeks: 120 mcg/kg BID.

All-Cause Mortality
rhIGF
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
rhIGF
Affected / at Risk (%)
Total   0/3 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
rhIGF
Affected / at Risk (%)
Total   0/3 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Julie Rice, RN
Organization: Nationwide Children's Hospital
Phone: 6143553142
EMail: julie.rice@nationwidechildrens.org
Layout table for additonal information
Responsible Party: Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT00764699    
Other Study ID Numbers: IRB08-00213
First Submitted: October 1, 2008
First Posted: October 2, 2008
Results First Submitted: May 15, 2015
Results First Posted: March 2, 2018
Last Update Posted: March 2, 2018