Long-term safety follow-up after growth hormone treatment (rhGH) of short children born Small for Gestational Age (SGA)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-001364-72-HU

Enrollment

200

Registered

2007-06-25

Start date

2008-01-04

Completion date

Unknown

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth disturbance (current height standard deviation score (SDS) < -2.5 and parental adjusted SDS < -1) in short children born small for gestational age (SGA), with a birth weight and/or length below -2 standard deviation (SD), who failed to show catch-up growth (height velocity (HV) SDS < 0 during the last year) by 4 years of age or later MedDRA version: 17.1 Level: LLT Classification code 10018747 Term: Growth hormone System Organ Class: 100000004848

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. All patients who fulfilled the diagnosis SGA, participated in study EP00-401, and received at least one dose of study medication 2. Written informed patient of patient (for children who can read and write) and parent or legal guardian Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patients unwilling and/or parents/guardians who are not capable of ensuring compliance with the provisions of the study protocol

Design outcomes

Primary

Measure	Time frame
Main Objective: To monitor the development of diabetes during a long-term follow-up period (10 years) after treatment cessation.;Secondary Objective: - to monitor the development of anti-hGH and anti-HCP antibodies for 6 months after treatment cessation, - to evaluate the safety (incidence and occurrence of adverse events) for 10 years after treatment cessation;Primary end point(s): Safety endpoints: - Carbohydrate metabolism: XML File Identifier: Gix9rUo/zllFZhIWa4kTVZsHcWE= Page 10/20 Fasting plasma glucose and insulin levels will be measured 6 months, 1, 5 and 10 years after the end of treatment in study EP00-401 Glycosylated haemoglobin (HbA1C) will be measured 6 months, 1, 5 and 10 years after the end of treatment in study EP00-401 An oral glucose tolerance test (OGTT) will be performed 6 months, 1, 5 and 10 years after the end of treatment in study EP00-401 - Immunogenicity Anti-rhGH antibodies and E. coli host cell peptide (HCP) antibodies will be measured at baseline and visit F1. Only in the case of development of anti-rhGH antibodies or of E. coli host cell peptide (HCP) antibodies (ABs) in the previous visit follow-up measurements will be made 1, 5 and 10 years after end of treatment in study EP00-401. - Safety lab / urine analysis Hematology, blood chemistry and urine analysis will be measured at 6 months, 1, 5 and 10 years after the end of treatment in study EP00-401 unless more frequent assessment is clinically indicated - (Serious) Adverse events: Adverse events will be collected throughout the study. - Vital signs / weight: Vital signs (blood pressure, pulse) as well as weight will be examined at each visit. Efficacy endpoints: - Auxological: Height will be measured according to the usual clinical practice - Pharmacodynamic: IGF-I and IGFBP-3 serum levels will be assessed 6 months, 1, 5 and 10 years after the end of treatment in study EP00-401;Timepoint(s) of evaluation of this end point: Interim analyses are planned at the following time points: • 2	—

Measure

Time frame

Main Objective: To monitor the development of diabetes during a long-term follow-up period (10 years) after treatment cessation.;Secondary Objective: - to monitor the development of anti-hGH and anti-HCP antibodies for 6 months after treatment cessation, - to evaluate the safety (incidence and occurrence of adverse events) for 10 years after treatment cessation;Primary end point(s): Safety endpoints: - Carbohydrate metabolism: XML File Identifier: Gix9rUo/zllFZhIWa4kTVZsHcWE= Page 10/20 Fasting plasma glucose and insulin levels will be measured 6 months, 1, 5 and 10 years after the end of treatment in study EP00-401 Glycosylated haemoglobin (HbA1C) will be measured 6 months, 1, 5 and 10 years after the end of treatment in study EP00-401 An oral glucose tolerance test (OGTT) will be performed 6 months, 1, 5 and 10 years after the end of treatment in study EP00-401 - Immunogenicity Anti-rhGH antibodies and E. coli host cell peptide (HCP) antibodies will be measured at baseline and visit F1. Only in the case of development of anti-rhGH antibodies or of E. coli host cell peptide (HCP) antibodies (ABs) in the previous visit follow-up measurements will be made 1, 5 and 10 years after end of treatment in study EP00-401. - Safety lab / urine analysis Hematology, blood chemistry and urine analysis will be measured at 6 months, 1, 5 and 10 years after the end of treatment in study EP00-401 unless more frequent assessment is clinically indicated - (Serious) Adverse events: Adverse events will be collected throughout the study. - Vital signs / weight: Vital signs (blood pressure, pulse) as well as weight will be examined at each visit. Efficacy endpoints: - Auxological: Height will be measured according to the usual clinical practice - Pharmacodynamic: IGF-I and IGFBP-3 serum levels will be assessed 6 months, 1, 5 and 10 years after the end of treatment in study EP00-401;Timepoint(s) of evaluation of this end point: Interim analyses are planned at the following time points: • 2

—

Countries

Czech Republic, Germany, Hungary, Poland

Contacts

Public ContactNike Hucke

Sandoz Biopharmaceuticals

nike.hucke@sandoz.com+49 8024 476 2957

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026