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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00490100 |
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Date of registration:
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21/06/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment for Growth Failure in Patients With X-Linked Severe Combined Immunodeficiency: Phase 2 Study of Insulin-Like Growth Factor-1
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Scientific title:
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Treatment for Growth Failure in Patients With X-Linked Severe Combined Immunodeficiency (XSCID): A Phase 2 Study Assessing Safety and Clinical Response to Treatment With Insulin-like Growth Factor-1 (IGF-1) |
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Date of first enrolment:
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June 2007 |
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Target sample size:
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6 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00490100 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Suk S De Ravin, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Institute of Allergy and Infectious Diseases (NIAID) |
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Key inclusion & exclusion criteria
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- INCLUSION CRITERIA:
Participants Must:
- Have a diagnosis of XSCID
- Be between 2 years to 20 years old and have not completed puberty
- Consent to permit blood and/or tissue samples for storage
- Demonstrate short stature: height below the 3 rd percentile for chronological age
- Have a primary care physician at home
- Demonstrate growth failure, defined as growth velocity (measured as linear growth)
that is less than 5% to 10% of that expected for children of the same age group, over
the past 12 months
- Willingness to remain hospitalized for several days
- Provide evidence of serum IGF-1 level performed within the preceding 6 months and the
results fall below normal limits for age
EXCLUSION CRITERIA:
Participants Must NOT:
- Have fusion of epiphyseal plates
- Demonstrate any history of anaphylactic reaction or hypersensitivity to mecasermin or
any component of the drug's formulation
- Have any active or suspected neoplasia
- Demonstrate signs of intracranial hypertension as evidenced by papilledema upon
examination by fundoscopy
- Have any condition that, in the investigator's opinion, places the patient at undue
risk by participating in the study
- Be unwilling to undergo testing or procedures associated with this protocol
Age minimum:
2 Years
Age maximum:
20 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Growth Failure
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X-linked Severe Combined Immunodeficiency (XSCID)
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Growth Hormone Resistence
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Intervention(s)
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Drug: Increlex
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Primary Outcome(s)
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Safety of Study Drug
[Time Frame: 1 year]
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Change in Growth Rate on Study Drug
[Time Frame: During intervention, up to 2 years]
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Secondary ID(s)
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070171
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07-I-0171
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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