Clinical trial NCT01491854: Long-term Safety Follow-up After Growth Hormone Treatment of Short Children Born Small for Gestational Age
Official title: Long-term Safety Follow-up After Growth Hormone Treatment (rhGH) of Short Children Born Small for Gestational Age (SGA)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Short Children Born Small for Gestational Age (SGA)
Keywords: Long-term
safety
follow-up
growth hormone treatment
short children
Small for Gestational Age
Somatropin
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2011-12-14
Enrollment: 130
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is performed as part of the Marketing Authorisation Holder's post-marketing pharmacovigilance plan 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: The purpose of this study is

1. to monitor short children born SGA who were treated with growth hormone in study EP00-401 for the development of diabetes for a further 10 years after termination of growth hormone treatment

   and
2. to report the incidence of anti-rhGH antibodies and of E. coli host cell peptide (HCP) antibodies (ABs) for 6 months after termination of GH treatment.

Eligibility criteria: Inclusion Criteria:

* All patients who fulfilled the diagnosis SGA, participated in study EP00-401, and received at least one dose of study medication
* Written informed consent of patient (for children who can read and/ or understand) and/or parent or legal guardian

Exclusion Criteria:

* Patients unwilling and/or parents/guardians who are not capable of ensuring compliance with the provisions of the study protocol

Primary outcomes:
measure: Evaluate the Long-term Effect of Growth Hormone Treatment on the Development of Diabetes After End of Therapy.
timeFrame: 5 years
measure: To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Fasting Plasma Glucose (FPG) Levels
timeFrame: baseline, 6 months, 1 year, 5 years
measure: To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Fasting Insulin Levels
timeFrame: baseline, 6 months, 1 year, 5 years
measure: To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Glucose Glycolsylated Hemoglobin (HbA1c)
timeFrame: baseline, 6 months, 1 year, 5 years
measure: To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through HOMA and QUICKI Scores
timeFrame: baseline, 6 months, 1 year, 5 years
Secondary outcomes:
measure: to Evaluate IGF-I and IGFBP-3 Levels After End of Growth Hormone Treatment
timeFrame: baseline, 6 months, 1 year , 5 years
measure: To Evaluate the Incidence of Anti-rhGH Antibodies After Termination of Growth Hormone Treatment.
timeFrame: baseline, 6 months, 1 year, 5 years
measure: to Evaluate Final Height
timeFrame: baseline, 6 months, 1 year, 5 years
Other outcomes:
Locations:
city: Usti nad Labem
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Hradec Kralove
country: Czechia
facility: Novartis Investigative Site
city: Praha 5
country: Czechia
facility: Novartis Investigative Site
city: Tbilisi
country: Georgia
facility: Novartis Investigative Site
city: Nordrhein Westfalen
country: Germany
facility: Novartis Investigative Site
state: Sankt Augustin
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Miskolc
country: Hungary
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
state: Dolnoslaskie
city: Wrocław
country: Poland
facility: Novartis Investigative Site
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Novartis Investigative Site
state: Kujawsko-pomorskie
city: Rzeszow
country: Poland
facility: Novartis Investigative Site
state: Podkarpackie
city: Katowice
country: Poland
facility: Novartis Investigative Site
state: Slaskie
city: Zabrze
country: Poland
facility: Novartis Investigative Site
state: Slaskie
city: Kielce
country: Poland
facility: Novartis Investigative Site
state: Swietokrzyskie
city: Poznai
country: Poland
facility: Novartis Investigative Site
state: Wielkopolskie
city: Gdansk
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Szczecin
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Lasi
country: Romania
facility: Novartis Investigative Site
state: Iasi
city: Bucuresti
country: Romania
facility: Novartis Investigative Site
city: Cluj Napoca
country: Romania
facility: Novartis Investigative Site
Study officials:
affiliation: Sandoz GmbH
name: Sandoz Biopharmaceuticals Sandoz
role: STUDY_CHAIR
References: