A follow-up study to examine the presence of anti-human growth hormone antibodies following a randomised, open-label, parallel-group, multi-centre trial (FE 999905 CS07) in which the efficacy and safety of 12 months’ treatment with one daily dose of ZOMACTON were compared to one daily dose of GENOTROPI

Conditions: Idiopathic growth hormone deficiency
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2014-000627-24-PL

Lead Sponsor: Ferring Pharmaceuticals A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 46

Inclusion Criteria

- Previous participation in trial FE 999905 CS07 and presence of anti-hGH antibodies at any post-dosing visit throughout the 12-month treatment period
- Signed informed consent and obtained assent according to local rules and practice
- Information on medical history, concomitant medications, and growth hormone therapy since completion of trial FE 999905 CS07

Are the trial subjects under 18? yes
Number of subjects for this age range: 46
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

There are no pre-defined exclusion criteria in this study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: - To investigate the presence of neutralising antibodies in confirmed anti-hGH antibody positive samples <br><br>- To investigate binding capacity levels in confirmed anti-hGH antibody positive samples ;Primary end point(s): Prevalence of anti-hGH antibodies ;Timepoint(s) of evaluation of this end point: At a single Visit;Main Objective: To investigate the presence of remaining immunogenicity among previously anti-hGH antibody positive children who participated in the clinical trial FE 999905 CS07 and were treated with one daily dose of 0.03 mg/kg ZOMACTON (10 mg/mL) or one daily dose of 0.03 mg/kg GENOTROPIN (12 mg)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Prevalence of neutralising antibodies in confirmed positive anti-hGH antibody samples<br>- Binding capacity levels in confirmed anti-hGH antibody positive samples;Timepoint(s) of evaluation of this end point: At single Visit