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Main
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Note: This record shows only the 20 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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5 November 2012 |
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Main ID: |
NCT01400698 |
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Date of registration:
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21/07/2011 |
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Primary sponsor: |
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Public title:
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Saizen in Intra-uterine Growth Retardation
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Scientific title:
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An Open Study of the Safety and Efficacy of Saizen®, (Recombinant Human Growth Hormone, r-hGH), in Children Born With Serious Intra-uterine Growth Retardation (IUGR) Treated to Final Height |
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Date of first enrolment:
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November 1998 |
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Target sample size:
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91 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01400698 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Contacts
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Name:
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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Merck Serono S.A., Geneva |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Previous inclusion, good compliance and normal completion of GF4001 or GF6283 in the
treatment of growth failure in children born with serious IUGR (3-year continuous
r-hGH treatment in GF4001 or 2-year continuous or intermittent r-hGH treatment in
GF6283).
- Increase in height greater than 0.5 standard deviation (SD) during the first 2 years
of r-hGH treatment in GF4001 or after 2 years of continuous or intermittent r-hGH
treatment in GF6283.
- A written Informed Consent at the beginning of the pre-study visit must be obtained
from the parent(s)/legal guardian(s), with the understanding that consent may be
withdrawn by the subject or parents at any time without prejudice to their future
medical care. Children able to understand the trial should personally sign and date
the written informed consent, too.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Known multiple malformation syndrome with severe psychomotor retardation and/or body
hemihypertrophy.
- Severe psychomotor retardation.
- Severe congenital malformations.
- Other protocol-defined exclusion criteria may apply.
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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Children Born With Serious Intra-uterine Growth Retardation
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Intervention(s)
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Drug: Saizen® A
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Drug: Saizen® B
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Other: Observation only
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Primary Outcome(s)
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Final Height
[Time Frame: One year after final height was attained up to 10.6 years]
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Height Standard Deviation Score (HSDS)
[Time Frame: One year after final height was attained up to 10.6 years]
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Secondary Outcome(s)
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Parental Adjusted Height Standard Deviation Score (PAHSDS)
[Time Frame: One year after final height was attained up to 10.6 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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