Trial · Interventional

TerminatedNot applicableResults postedRegistry data

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

Short name SGA

NCTNCT01491854Other idCEP00-402

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

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

Results were posted for this trial.

This trial does not test a peptide that PepBank tracks.

Names HGH (somatotropin), does not test it. It appears in the description.

Overview

Status: Terminated
Phase: Not applicable
Enrollment: 130 participants (actual)
Sponsor: Sandoz · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 6 countries
Czechia, Georgia, Germany, Hungary, Poland, Romania
Start: 20 Jul 2009
Primary completion: 31 Oct 2018
Completion: 31 Oct 2018
First posted: 14 Dec 2011 (estimated)
Last update posted: 14 Aug 2019
Conditions: Short Children Born Small for Gestational Age (SGA)

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20102012201420162018

N/A
SGA
NCT01491854
20 Jul 2009 to 31 Oct 2018
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

BloodsamplingOther

Arms1

Other
Monitoring of long-term safety
Long-term safety follow-up after the end of treatment with Omnitrope (single arm)

Primary outcomes5

Outcomes the sponsor listed as primary.

Evaluate the Long-term Effect of Growth Hormone Treatment on the Development of Diabetes After End of Therapy.
Time frame · 5 years
Registry description
Number of participants diagnosed with Diabetes mellitus type 2 during the study, defined as fullfilment of these 3 criteria: * FPG ≥ 126 mg/dl (7.0 mmol/L) during blood sampling and/or during Oral Glucose Tolerance Test (OGTT) * 2-h plasma glucose ≥ 200 mg/dl (11.1 mmol/L) during an OGTT * Investigator documenting diagnosis of diabetes mellitus type 2 during OGTT
To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Fasting Plasma Glucose (FPG) Levels
Time frame · baseline, 6 months, 1 year, 5 years
Registry description
Supportive to Primary Endpoint
To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Fasting Insulin Levels
Time frame · baseline, 6 months, 1 year, 5 years
Registry description
Supportive to Primary Endpoint
To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Glucose Glycolsylated Hemoglobin (HbA1c)
Time frame · baseline, 6 months, 1 year, 5 years
Registry description
Supportive to Primary Endpoint
To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through HOMA and QUICKI Scores
Time frame · baseline, 6 months, 1 year, 5 years
Registry description
Supportive to Primary Endpoint. HOMA = homeostasis model assessment for Insulin resistance: Healthy Range: 1.0 (0.5-1.4). \< 1.0 means you are insulin-sensitive which is optimal. \>1.9 indicates early insulin resistance. \> 2.9 indicates significant insulin resistance. The quantitative insulin sensitivity check index (QUICKI) measures insulin sensitivity, which is the inverse of insulin resistance. The QUICKI calculation for insulin resistance in humans fall broadly within a range between 0.45 for unusually healthy individuals and 0.30 in diabetics. Lower numbers reflect greater insulin resistance.

Secondary outcomes(3)

to Evaluate IGF-I and IGFBP-3 Levels After End of Growth Hormone Treatment
Time frame · baseline, 6 months, 1 year , 5 years
To Evaluate the Incidence of Anti-rhGH Antibodies After Termination of Growth Hormone Treatment.
Time frame · baseline, 6 months, 1 year, 5 years
Registry description
number of participants with positive results for anti-drug antibody (ADA). Percentages indicated are calculated based on the total number of patients (118 participants).
to Evaluate Final Height
Time frame · baseline, 6 months, 1 year, 5 years

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· 5 years

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

Group	Value (Participants)
Monitoring of Long-term Safety	0

Primary outcomeMean· baseline, 6 months, 1 year, 5 years

To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Fasting Plasma Glucose (FPG) Levels

Group	Value (mmol/L)	Spread
Monitoring of Long-term Safety	4.69	0.492

Primary outcomeMean· baseline, 6 months, 1 year, 5 years

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

Group	Value (pmol/L)	Spread
Monitoring of Long-term Safety	70.87	38.477

Primary outcomeMean· baseline, 6 months, 1 year, 5 years

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

Group	Value (percentage)	Spread
Monitoring of Long-term Safety	5.280	0.3569

Primary outcomeMean· baseline, 6 months, 1 year, 5 years

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

Group	Value (score on a scale)	Spread
Monitoring of Long-term Safety	2.082	1.0336

Secondary and other outcome results(3)

Secondary outcomeMean· baseline, 6 months, 1 year , 5 years

to Evaluate IGF-I and IGFBP-3 Levels After End of Growth Hormone Treatment

Group	Value (nmol/L)	Spread
Monitoring of Long-term Safety	67.42	31.137

Secondary outcomeCount of participants· baseline, 6 months, 1 year, 5 years

To Evaluate the Incidence of Anti-rhGH Antibodies After Termination of Growth Hormone Treatment.

Group	Value (Participants)
Monitoring of Long-term Safety	0

Secondary outcomeMean· baseline, 6 months, 1 year, 5 years

to Evaluate Final Height

Group	Value (cm)	Spread
Monitoring of Long-term Safety	152.63	16.362

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
TotalTotal	1 / 118	8 / 118	23 / 118

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 4 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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