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

Phase 1

• 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: 20.0Level: LLTClassification code 10018747Term: Growth hormoneSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2007-001364-72-PL
• Lead Sponsor: Sandoz GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-07
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

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/or write) and/or 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 0

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified