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
2 other identifiers
interventional
23
7 countries
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2014
Shorter than P25 for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2014
CompletedFirst Posted
Study publicly available on registry
June 25, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedMay 5, 2015
May 1, 2015
6 months
June 23, 2014
May 4, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Prevalence of anti-human Growth Hormone (hGH) antibodies
Measured as percentage of patients with positive anti-hGH antibodies.
At visit 1
Secondary Outcomes (2)
Prevalence of neutralising antibodies in confirmed positive anti-hGH antibody samples
At visit 1
Binding capacity levels in confirmed anti-hGH antibody positive samples
At visit 1
Interventions
Blood sample will be collected at a single visit
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Szent János Kórház és Észak Budai Egyesített Kórházai (there may be other sites in this country)
Budapest, Hungary
Seth GSMC & KEM Hospital (there may be other sites in this country)
Maharashtra, India
The Chaim Sheba Medical Center (there may be other sites in this country)
Ramat Gan, Israel
Uniwersyteckie Centrum Kliniczne (there may be other sites in this country)
Gdansk, Poland
Paediatric Endocrinology/Medicali's SRL (there may be other sites in this country)
Timișoara, Romania
Federal State Institution "Endocrinology Scientific Center of Rosmedtechnology" (there may be other sites in this country)
Moscow, Russia
Institute of Endocrinology and Metabolism named after Komisarenko of AMS Ukraine (there may be other sites in this country)
Kiev, Ukraine
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2014
First Posted
June 25, 2014
Study Start
October 1, 2014
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
May 5, 2015
Record last verified: 2015-05