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: 20.0 Level: LLT Classification code 10018747 Term: Growth hormone System Organ Class: 100000007153; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-20
• Study Completion: 2018-10-31
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 118

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 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