TerminatedNot Applicable

Long-term Safety Follow-up After Growth Hormone Treatment of Short Children Born Small for Gestational Age

Stopped: in accordance with the request to close study EP00-402 "EMEA/H/C/000607/MEA 10.2" submitted and adopted by the EMA

Czechia, Georgia, Germany130 participantsStarted 2009-07-20

Plain-language 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).

Who can participate

Age range4 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Evaluate the Long-term Effect of Growth Hormone Treatment on the Development of Diabetes After End of Therapy.

Timeframe: 5 years

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

To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Fasting Insulin Levels

Timeframe: baseline, 6 months, 1 year, 5 years

To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Glucose Glycolsylated Hemoglobin (HbA1c)

Timeframe: baseline, 6 months, 1 year, 5 years

To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through HOMA and QUICKI Scores

Timeframe: baseline, 6 months, 1 year, 5 years

Trial details

NCT IDNCT01491854

SponsorSandoz

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-10-31

Results submitted2019-04-29

View on ClinicalTrials.gov More Short Children Born Small for Gestational Age (SGA) trials

Who can participate

Age range4 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Evaluate the Long-term Effect of Growth Hormone Treatment on the Development of Diabetes After End of Therapy.

Timeframe: 5 years

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

To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Fasting Insulin Levels

Timeframe: baseline, 6 months, 1 year, 5 years

To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Glucose Glycolsylated Hemoglobin (HbA1c)

Timeframe: baseline, 6 months, 1 year, 5 years

To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through HOMA and QUICKI Scores

Timeframe: baseline, 6 months, 1 year, 5 years