Clinical trial NCT00537914: Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)
Official title: Long-term Phase IV Multicentre Study on the Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Small for Gestational Age
Keywords: Small for Gestational Age, Omnitrope®/Somatropin, rhGH,SGA
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2007-10-02
Enrollment: 278
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: Prospective, open label, non-comparative, multicenter study. Short children born SGA were to be treated until they reached final height, but treatment could be discontinued earlier if medically indicated or if there was inadequate response to treatment.

Eligibility 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 defined as current height SDS \< -2.5 (and parental adjusted SDS \<-1) 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
* Known IGF-I level above +2SD for sex and age
* Acute critical illness
* Previous treatment with any hGH preparation
* Treatment with antidiabetic medication (e.g. metformin, insulin)
* Drug abuse, substance abuse, or alcohol abuse

Primary outcomes:
measure: Number of Participants With Development of Diabetes in Short Children Born SGA During Treatment
timeFrame: throughout the study, approximately 13 years
Secondary outcomes:
measure: Mean Change in Height (H) (cm) From Baseline
timeFrame: Baseline, 3 months, 1 year, 2 years, 5 years and 9 years
measure: Mean Change in Height Standard Deviation Score Over Time From Baseline
timeFrame: Baseline, 3 months, 0.5 year, 9 months, 1 year, 1.25 years, 1.5 years, 1.75 years, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years, 11 years, 12 years, 12.5 years
measure: Mean Change in Height Velocity (HV) (cm/Year) Over Time From Baseline
timeFrame: Baseline, 3 months, 1 year, 2 years, 5 years and 9 years
measure: Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline
timeFrame: Baseline, 3 months, 0.5 year, 9 months, 1 year, 1.25 years, 1.5 years, 1.75 years, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years, 11 years, 12 years, 12.5 years
measure: Mean Change in Serum IGF-1 Level (Nmol/L) From Baseline
timeFrame: Baseline, 3 months, 1 year, 2 years, 5 years and 9 years
measure: Mean Change in IGFBP-3 Levels (Nmol/L) From Baseline
timeFrame: Baseline, 3 months, 1 year, 2 years, 5 years and 9 years
measure: Number of Participants With the Development of Anti-rhGH Antibodies During Omnitrope Treatment
timeFrame: throughout the study, approximately 13 years
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Sandoz Investigational Site
state: Antwerpen
city: Praha 5
country: Czechia
facility: Sandoz Investigational Site
state: Praha
city: Hradec Kralove
country: Czechia
facility: Sandoz Investigational Site
city: Usti nad Labem
country: Czechia
facility: Sandoz Investigational Site
city: Tbilisi
country: Georgia
facility: Sandoz Investigational Site
city: Muenchen
country: Germany
facility: Sandoz Investigational Site
state: Bayern
city: Sankt Augustin
country: Germany
facility: Sandoz Investigational Site
state: Nordrhein Westfalen
city: Szeged
country: Hungary
facility: Sandoz Investigational Site
state: Csongrad
city: Budapest
country: Hungary
facility: Sandoz Investigational Site
city: Budapest
country: Hungary
facility: Sandoz Investigational Site
city: Gyor
country: Hungary
facility: Sandoz Investigational Site
city: Miskolc
country: Hungary
facility: Sandoz Investigational Site
city: Wrocław
country: Poland
facility: Sandoz Investigational Site
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Sandoz Investigational Site
state: Kujawsko-pomorskie
city: Rzeszow
country: Poland
facility: Sandoz Investigational Site
state: Podkarpackie
city: Katowice
country: Poland
facility: Sandoz Investigational Site
state: Slaskie
city: Zabrze
country: Poland
facility: Sandoz Investigational Site
state: Slaskie
city: Kielce
country: Poland
facility: Sandoz Investigational Site
state: Swietokrzyskie
city: Poznań
country: Poland
facility: Sandoz Investigational Site
state: Wielkopolskie
city: Gdansk
country: Poland
facility: Sandoz Investigational Site
city: Katowice
country: Poland
facility: Sandoz Investigational Site
city: Krakow
country: Poland
facility: Sandoz Investigational Site
city: Lodz
country: Poland
facility: Sandoz Investigational Site
city: Szczecin
country: Poland
facility: Sandoz Investigational Site
city: Warszawa
country: Poland
facility: Sandoz Investigational Site
city: Wroclaw
country: Poland
facility: Sandoz Investigational Site
city: Cluj Napoca
country: Romania
facility: Sandoz Investigational Site
state: Cluj
city: Bucuresti
country: Romania
facility: Sandoz Investigational Site
city: Bucuresti
country: Romania
facility: Sandoz Investigational Site
city: Craiova
country: Romania
facility: Sandoz Investigational Site
city: Iaşi
country: Romania
facility: Sandoz Investigational Site
Study officials:
affiliation: Sandoz GmbH
name: Sandoz Biopharmaceuticals
role: STUDY_CHAIR
References: