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 GENOTROPIN

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000627-24-HU

Enrollment

Registered

2014-05-14

Start date

2014-06-26

Completion date

Unknown

Last updated

2015-09-14

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

Conditions

Idiopathic growth hormone deficiency

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 Objective: - To investigate the presence of neutralising antibodies in confirmed anti-hGH antibody positive samples - 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	—

Measure

Time frame

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 Objective: - To investigate the presence of neutralising antibodies in confirmed anti-hGH antibody positive samples - 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

—

Secondary

Measure	Time frame
Secondary end point(s): - Prevalence of neutralising antibodies in confirmed positive anti-hGH antibody samples - Binding capacity levels in confirmed anti-hGH antibody positive samples;Timepoint(s) of evaluation of this end point: At single Visit	—

Countries

Hungary, India, Israel, Poland, Romania, Russian Federation, Ukraine

Contacts

Public ContactClinical Development Support

Ferring Pharmaceuticals A/S

DK0-Disclosure@ferring.com004588 33 88 34

Outcome results

None listed

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