Back to resultsA 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
Primary Purpose
Idiopathic Growth Hormone Deficiency
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
About this trial
This is an interventional trial for Idiopathic Growth Hormone Deficiency
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
Sites / Locations
- Szent János Kórház és Észak Budai Egyesített Kórházai (there may be other sites in this country)
- Seth GSMC & KEM Hospital (there may be other sites in this country)
- The Chaim Sheba Medical Center (there may be other sites in this country)
- Uniwersyteckie Centrum Kliniczne (there may be other sites in this country)
- Paediatric Endocrinology/Medicali's SRL (there may be other sites in this country)
- Federal State Institution "Endocrinology Scientific Center of Rosmedtechnology" (there may be other sites in this country)
- Institute of Endocrinology and Metabolism named after Komisarenko of AMS Ukraine (there may be other sites in this country)
Outcomes
Primary Outcome Measures
Prevalence of anti-human Growth Hormone (hGH) antibodies
Measured as percentage of patients with positive anti-hGH antibodies.
Secondary Outcome Measures
Prevalence of neutralising antibodies in confirmed positive anti-hGH antibody samples
Measured as percentage of patients with neutralising antibodies in patients with confirmed positive anti-hGH antibody samples.
Binding capacity levels in confirmed anti-hGH antibody positive samples
Measured as percentage of patients with binding capacity <2 mg/L in patients with confirmed positive anti-hGH antibody samples.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02173821
Brief Title
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
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Growth Hormone Deficiency
7. Study Design
Study Phase
Phase 3
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Blood sampling
Intervention Description
Blood sample will be collected at a single visit
Primary Outcome Measure Information:
Title
Prevalence of anti-human Growth Hormone (hGH) antibodies
Description
Measured as percentage of patients with positive anti-hGH antibodies.
Time Frame
At visit 1
Secondary Outcome Measure Information:
Title
Prevalence of neutralising antibodies in confirmed positive anti-hGH antibody samples
Description
Measured as percentage of patients with neutralising antibodies in patients with confirmed positive anti-hGH antibody samples.
Time Frame
At visit 1
Title
Binding capacity levels in confirmed anti-hGH antibody positive samples
Description
Measured as percentage of patients with binding capacity <2 mg/L in patients with confirmed positive anti-hGH antibody samples.
Time Frame
At visit 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Szent János Kórház és Észak Budai Egyesített Kórházai (there may be other sites in this country)
City
Budapest
Country
Hungary
Facility Name
Seth GSMC & KEM Hospital (there may be other sites in this country)
City
Maharashtra
Country
India
Facility Name
The Chaim Sheba Medical Center (there may be other sites in this country)
City
Ramat Gan
Country
Israel
Facility Name
Uniwersyteckie Centrum Kliniczne (there may be other sites in this country)
City
Gdansk
Country
Poland
Facility Name
Paediatric Endocrinology/Medicali's SRL (there may be other sites in this country)
City
Timisoara
Country
Romania
Facility Name
Federal State Institution "Endocrinology Scientific Center of Rosmedtechnology" (there may be other sites in this country)
City
Moscow
Country
Russian Federation
Facility Name
Institute of Endocrinology and Metabolism named after Komisarenko of AMS Ukraine (there may be other sites in this country)
City
Kiev
Country
Ukraine
12. IPD Sharing Statement
Learn more about this trial
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
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