Status:
COMPLETED
Saizen in Intra-uterine Growth Retardation
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck Serono S.A., Geneva
Conditions:
Children Born With Serious Intra-uterine Growth Retardation
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
Study of safety of Saizen® in children born with serious intra-uterine growth retardation (IUGR) treated to final height. An open, phase III study involving 17 centers in France. The study enrolled c...
Eligibility Criteria
Inclusion
- 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the pre-study visit must be obtained from the parent(s)/legal guardian(s), with the understanding that consent may be withdrawn by the subject or parents at any time without prejudice to their future medical care.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
- 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.
Key Trial Info
Start Date :
November 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT01400698
Start Date
November 1 1998
End Date
February 1 2010
Last Update
September 18 2013
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.