Safety and Efficacy of Somatropin (rhGH) in Short Children Born Small for Gestational Age (SGA)

This study is currently recruiting participants.

Verified by Novartis, November 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00537914

Purpose

This study is performed to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (SGA).

Condition	Intervention	Phase
Infant, Small for Gestational Age, SGA	Drug: Somatropin	Phase IV

Drug Information available for: Somatotropin Somatropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Long-Term Phase IV Multicentre Study on the Safety and Efficacy of Somatropin (rhGH) in Short Children Born Small for Gestational Age (SGA)

Further study details as provided by Novartis:

Primary Outcome Measures:

The primary objective of this study is to evaluate the long-term effect of somatropin on the development of diabetes during the treatment period in short children born SGA.

Secondary Outcome Measures:

•to report the incidence of anti-rhGH AB´s and of E. coli host cell peptide AB´s during treatment •to evaluate the efficacy of somatropin treatment in SGA, IGF-I and IGFBP-3 levels during treatment and incidence and severity of adverse events

Estimated Enrollment:	240
Study Start Date:	October 2007

Arms	Assigned Interventions
1: Active Comparator	Drug: Somatropin Infant, Small for Gestational Age, somatropin, rhGH,

Eligibility

Ages Eligible for Study:	4 Years to 18 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Pre-pubertal (Tanner stage I) children born SGA
- Boys: 4 years of age or older
- Girls: 4 years of age or older
Growth disturbance for chronological age and sex according to country specific references
Birth weight and/or length below -2 standard deviations (SD) for gestational age

Exclusion Criteria:

Onset of puberty
Closed epiphyses
Diabetes mellitus type I or type II
Fasting blood glucose greater than 100 mg/dl or greater than 5.6 mmol/l measured in venous blood sample
Abnormal findings in Oral Glucose Tolerance Test (OGTT) defined by greater than 140 mg/dl or greater than 7.8 mmol/l after 120 minutes
Acute critical illness
Previous treatment with any hGH preparation
Treatment with antidiabetic medication (e.g. metformin, insulin)
Drug abuse, substance abuse, or alcohol abuse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537914

Contacts

Contact: Sandoz SDZ Sandoz

+49 (0)89 61 36 70 200

Locations

Belgium
	Recruiting
Brussels, Belgium
Czech Republic
	Recruiting
Prague, Czech Republic
Germany
	Recruiting
Munich, Germany
Hungary
	Recruiting
Budapest, Hungary
Poland
	Recruiting
Szczencin, Poland
Romania
	Recruiting
Bucharest, Romania

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Sandoz SDZ Sandoz, PH.D

Sandoz Inc.

More Information

Responsible Party:	Sandoz ( Sandoz )
Study ID Numbers:	EP00-401
Study First Received:	October 1, 2007
Last Updated:	November 7, 2008
ClinicalTrials.gov Identifier:	NCT00537914
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Poland: Ministry of Health an Social Secruity; Hungary: National Institute of Pharmacy; Czech Republic: State Institute for Drug Control; Belgium: Pharmaceutical Inspectorate; Romania: Ministry of Health and the Familiy

Keywords provided by Novartis:

Infant, Small for Gestational Age, somatropin, rhGH,SGA

ClinicalTrials.gov processed this record on January 15, 2009