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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 February 2015 |
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Main ID: |
NCT01901666 |
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Date of registration:
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29/06/2013 |
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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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Assessment Of Gh-Igf-1 Axis In Children With Chronic Myelogenous Leukemia (CML) In Remission
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Scientific title:
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ASSESSMENT OF GH-IGF1 AXIS AND TO STUDY RESPONSE TO GH THERAPY IN CHILDREN WITH CML IN REMISSION HAVING GH DEFICIENCY |
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Date of first enrolment:
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January 2013 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01901666 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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Phase 4
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Countries of recruitment
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India
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Contacts
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Name:
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ANIL BHANSALI, MBBS, MD,DM |
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Address:
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Telephone:
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9316977995 |
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Email:
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anilbhansaliendocrine@rediffmail.com |
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Affiliation:
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Name:
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anil bhansali, MBBS,MD,DM |
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Address:
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Telephone:
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9316977995 |
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Email:
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anilbhansaliendocrine@rediffmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
CML patients on Imatinib therapy for more than 6 months and in remission will be included
in the study if there is
1. severe short stature (height SDS <-3 SD)
2. severe growth deceleration (height velocity <-2 SD over 12 months)
3. Height <-2 SD and height velocity <-1.0 SD over 12 months
4. Height <-1.5 SD and height velocity <-1.5 SD over 2 years
Exclusion Criteria:
1. Patients with coexisting systemic illness(e.g. kidney disease, liver disease, celiac
disease).
2. Patients of CML not receiving Imatinib therapy as prescribed (poor compliance).
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Myelogenous Leukemia
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Short Stature
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Intervention(s)
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Drug: Growth Hormone
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Primary Outcome(s)
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To know whether patients of CML who are faltering on growth after imatinib therapy are GH deficient or having GH resistance by performing GH provocation tests and IGF-1 generation test.
[Time Frame: 30 months]
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Secondary Outcome(s)
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To administer growth hormone therapy to children with CML on Imatinib in remission having GH deficiency and to measure IGF-1 levels, gain in height and height velocity on GH therapy.
[Time Frame: 12 months]
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Secondary ID(s)
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GH-IGF-1 AXIS AND CML
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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