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

Phase 1

• Conditions: MedDRA version: 17.1Level: LLTClassification code 10018747Term: Growth hormoneSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Hormonal diseases [C19]; 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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-25
• Last Update Posted: 20 August 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
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

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