Clinical trial NCT02173821: A Follow-up Study to Examine the Presence of Anti-human Growth Hormone Antibodies Following a Study (FE 999905 CS07) of Zomacton in Children With Growth Hormone Deficiency
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Idiopathic Growth Hormone Deficiency
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-06-25
Enrollment: 23
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no

Brief summary: This is a follow-up study of patients, treated with one daily dose of Zomacton or one daily dose of Genotropin in the previously completed FE 999905 CS07 trial, who had presence of anti-hGH antibodies at any post-dosing visit during the 12-month treatment period. No investigational medicinal product will be administered in connection with this follow-up study. Eligible patients will attend one visit in this follow-up study.


Eligibility 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

Exclusion Criteria:

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

Primary outcomes:
measure: Prevalence of anti-human Growth Hormone (hGH) antibodies
timeFrame: At visit 1
Secondary outcomes:
measure: Prevalence of neutralising antibodies in confirmed positive anti-hGH antibody samples
timeFrame: At visit 1
measure: Binding capacity levels in confirmed anti-hGH antibody positive samples
timeFrame: At visit 1
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Szent János Kórház és Észak Budai Egyesített Kórházai (there may be other sites in this country)
city: Maharashtra
country: India
facility: Seth GSMC & KEM Hospital (there may be other sites in this country)
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center (there may be other sites in this country)
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne (there may be other sites in this country)
city: Timisoara
country: Romania
facility: Paediatric Endocrinology/Medicali's SRL (there may be other sites in this country)
city: Moscow
country: Russian Federation
facility: Federal State Institution "Endocrinology Scientific Center of Rosmedtechnology" (there may be other sites in this country)
city: Kiev
country: Ukraine
facility: Institute of Endocrinology and Metabolism named after Komisarenko of AMS Ukraine (there may be other sites in this country)
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: