An interventional study of Bloodsampling in Short Children Born Small for Gestational Age (SGA), sponsored by Sandoz. Terminated at 23 sites in 6 countries. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2019-08-14.
Sponsored by Sandoz · Not applicable, Interventional, and Other
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).
The purpose of this study is
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
Sandoz is the lead sponsor of 136 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Long-term safety follow-up after the end of treatment with Omnitrope (single arm)
Other: Bloodsampling
Bloodsampling
Evaluate the Long-term Effect of Growth Hormone Treatment on the Development of Diabetes After End of Therapy.
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
Time frame: 5 years
To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Fasting Plasma Glucose (FPG) Levels
Supportive to Primary Endpoint
Time frame: baseline, 6 months, 1 year, 5 years
To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Fasting Insulin Levels
Supportive to Primary Endpoint
Time frame: baseline, 6 months, 1 year, 5 years
To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Glucose Glycolsylated Hemoglobin (HbA1c)
Supportive to Primary Endpoint
Time frame: baseline, 6 months, 1 year, 5 years
To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through HOMA and QUICKI Scores
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.
Time frame: baseline, 6 months, 1 year, 5 years
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.
number of participants with positive results for anti-drug antibody (ADA). Percentages indicated are calculated based on the total number of patients (118 participants).
Time frame: baseline, 6 months, 1 year, 5 years
to Evaluate Final Height
Time frame: baseline, 6 months, 1 year, 5 years
130 participants signed informed consent. Of the 130 enrolled subjects, 11 subjects had no post-baseline visit, leading to exclusion from the SAF/FAS. Another subject was excluded as he received treatment with Omnitrope, which was not consistent with the protocol. Accordingly, 118 subjects comprised the SAF and in the FAS
| Milestone | Monitoring of Long-term Safety |
|---|---|
| Started | 130 |
| Completed | 0 |
| Not completed | 130 |
| Withdrew: Mainly due to premature termination | 93 |
| Withdrew: Death | 1 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Lost to follow-up | 33 |
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
| Participants | Monitoring of Long-term Safety |
|---|---|
| Evaluate the Long-term Effect of Growth Hormone Treatment on the Development of Diabetes After End of Therapy. | 0 |
| nmol/L | Monitoring of Long-term Safety |
|---|---|
| IGF-1 baseline | 67.42 ± 31.137 |
| IGF-1 6 months | 48.42 ± 20.002 |
| IGF-1 1 year | 46.28 ± 21.555 |
| IGF-1 5 years | 44.60 ± 16.035 |
| IGFBP-3 baseline | 211.12 ± 49.523 |
| IGFBP-3 6 months | 187.79 ± 42.999 |
| IGFBP-3 1 year | 186.59 ± 47.246 |
| IGFBP-3 5 years | 180.00 ± 26.470 |
number of participants with positive results for anti-drug antibody (ADA). Percentages indicated are calculated based on the total number of patients (118 participants).
| Participants | Monitoring of Long-term Safety |
|---|---|
| baseline | 0 |
| 6 months | 1 |
| 1 year | 0 |
| 5 years | 0 |
Supportive to Primary Endpoint
| mmol/L | Monitoring of Long-term Safety |
|---|---|
| FPG baseline | 4.69 ± 0.492 |
| FPG 6 months | -0.13 ± 0.567 |
| FPG 1 year | -0.14 ± 0.457 |
| FPG 5 years | -0.37 ± 0.856 |
Supportive to Primary Endpoint
| pmol/L | Monitoring of Long-term Safety |
|---|---|
| baseline | 70.87 ± 38.477 |
| 6 months | -2.34 ± 38.267 |
| 1 year | -7.48 ± 34.676 |
| 5 years | 3.40 ± 52.526 |
Supportive to Primary Endpoint
| percentage | Monitoring of Long-term Safety |
|---|---|
| baseline | 5.280 ± 0.3569 |
| 6 months | -0.057 ± 0.3621 |
| 1 year | -0.108 ± 0.2931 |
| 5 years | -0.308 ± 0.6036 |
| cm | Monitoring of Long-term Safety |
|---|---|
| baseline | 152.63 ± 16.362 |
| 6 months | 152.41 ± 16.894 |
| 1 year | 152.43 ± 16.698 |
| 5 years | 150.42 ± 12.938 |
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.
| score on a scale | Monitoring of Long-term Safety |
|---|---|
| HOMA score baseline | 2.082 ± 1.0336 |
| HOMA score 6 months | -0.073 ± 1.1447 |
| HOMA score 1 year | -0.206 ± 1.0170 |
| HOMA score 5 years | 0.094 ± 1.8835 |
| QUICKI score baseline | 0.354 ± 0.0459 |
| QUICKI score 6 months | 0.004 ± 0.0350 |
| QUICKI score 1 year | 0.012 ± 0.0413 |
| QUICKI score 5 years | 0.022 ± 0.0703 |
Collected over approximately 9 years. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Total | 1/118 (0.8%) | 8/118 (6.8%) | 23/118 (19.5%) |
| Event | Total |
|---|---|
| SyncopeNervous system disorders | 2/118 |
| AnaemiaBlood and lymphatic system disorders | 1/118 |
| ArrhythmiaCardiac disorders | 1/118 |
| Gastrooesophageal reflux diseaseGastrointestinal disorders | 1/118 |
| Hiatus herniaGastrointestinal disorders | 1/118 |
| Chronic tonsillitisInfections and infestations | 1/118 |
| NasopharyngitisInfections and infestations | 1/118 |
| PneumoniaInfections and infestations | 1/118 |
| SepsisInfections and infestations | 1/118 |
| Urinary tract infectionInfections and infestations | 1/118 |
| Event | Total |
|---|---|
| NasopharyngitisInfections and infestations | 7/118 |
| PharyngitisInfections and infestations | 5/118 |
| HypothyroidismEndocrine disorders | 4/118 |
| Respiratory tract infectionInfections and infestations | 4/118 |
| Upper respiratory tract infectionInfections and infestations | 4/118 |
| AcneSkin and subcutaneous tissue disorders | 4/118 |
| HeadacheNervous system disorders | 3/118 |
| Age, Continuous(years) | Monitoring of Long-term Safety |
|---|---|
| Mean | 14.79 ± 2.848 |
| Sex: Female, Male(Participants) | Monitoring of Long-term Safety |
|---|---|
| Female | 64 |
| Male | 54 |
| Race/Ethnicity, Customized(Participants) | Monitoring of Long-term Safety |
|---|---|
| Caucasian | 118 |
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