Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents

This study has been completed.
Sponsor:
Collaborator:
Tercica
Information provided by (Responsible Party):
Madhusmita Misra, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00516386
First received: August 13, 2007
Last updated: December 10, 2013
Last verified: December 2013
Results First Received: November 23, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Anorexia Nervosa
Intervention: Drug: RhIGF-1

  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
Sixteen anorexia nervosa patients between the ages of 12-18 years were recruited. Patients were determined by their psychiatrists to meet criteria for AN as described in the Diagnostic and Statistical Manual of Mental Disorders (a).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Four subjects were not interested in the study after the screen, and two were lost to follow-up.

Reporting Groups
  Description
RhIGF-1 All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.

Participant Flow:   Overall Study
    RhIGF-1  
STARTED     16  
COMPLETED     10  
NOT COMPLETED     6  
not interested in the study                 4  
Lost to Follow-up                 2  



  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.
No text entered.

Reporting Groups
  Description
RhIGF-1 All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.

Baseline Measures
    RhIGF-1  
Number of Participants  
[units: participants]
  16  
Age  
[units: participants]
 
<=18 years     16  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  16.2  ± 0.5  
Gender  
[units: participants]
 
Female     16  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     16  



  Outcome Measures
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1.  Primary:   Change in Levels of Insulin Like Growth Factor-1 (IGF-I) Following Recombinant Human (rh) IGF-1 Administration in Girls With Anorexia Nervosa   [ Time Frame: Baseline and 7-10 days ]

2.  Secondary:   Change in Levels of N-terminal Propeptide of Type 1 Procollagen (P1NP) Following rhIGF-1 Administration in Girls With Anorexia Nervosa   [ Time Frame: Baseline and 7-10 days ]


  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
A limitation of our study is that this was not a randomized controlled trial of rhIGF-1 versus placebo.


  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: Madhu Misra, MD
Organization: Massachusetts General Hospital
phone: 617-724-5602
e-mail: mmisra@partners.org


Publications:

Responsible Party: Madhusmita Misra, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00516386     History of Changes
Other Study ID Numbers: 2006P-000737
Study First Received: August 13, 2007
Results First Received: November 23, 2010
Last Updated: December 10, 2013
Health Authority: United States: Food and Drug Administration