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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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ClinicalTrials.gov Identifier: NCT02173821
Recruitment Status : Completed
First Posted : June 25, 2014
Last Update Posted : May 5, 2015
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Idiopathic Growth Hormone Deficiency Procedure: Blood sampling Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
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 Start Date : October 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015



Intervention Details:
  • Procedure: Blood sampling
    Blood sample will be collected at a single visit


Primary Outcome Measures :
  1. Prevalence of anti-human Growth Hormone (hGH) antibodies [ Time Frame: At visit 1 ]
    Measured as percentage of patients with positive anti-hGH antibodies.


Secondary Outcome Measures :
  1. Prevalence of neutralising antibodies in confirmed positive anti-hGH antibody samples [ Time Frame: At visit 1 ]
    Measured as percentage of patients with neutralising antibodies in patients with confirmed positive anti-hGH antibody samples.

  2. Binding capacity levels in confirmed anti-hGH antibody positive samples [ Time Frame: At visit 1 ]
    Measured as percentage of patients with binding capacity <2 mg/L in patients with confirmed positive anti-hGH antibody samples.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02173821


Locations
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Hungary
Szent János Kórház és Észak Budai Egyesített Kórházai (there may be other sites in this country)
Budapest, Hungary
India
Seth GSMC & KEM Hospital (there may be other sites in this country)
Maharashtra, India
Israel
The Chaim Sheba Medical Center (there may be other sites in this country)
Ramat Gan, Israel
Poland
Uniwersyteckie Centrum Kliniczne (there may be other sites in this country)
Gdansk, Poland
Romania
Paediatric Endocrinology/Medicali's SRL (there may be other sites in this country)
Timisoara, Romania
Russian Federation
Federal State Institution "Endocrinology Scientific Center of Rosmedtechnology" (there may be other sites in this country)
Moscow, Russian Federation
Ukraine
Institute of Endocrinology and Metabolism named after Komisarenko of AMS Ukraine (there may be other sites in this country)
Kiev, Ukraine
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
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Study Director: Clinical Development Support Ferring Pharmaceuticals

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Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02173821     History of Changes
Other Study ID Numbers: 000134
2014-000627-24 ( EudraCT Number )
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Antibodies
Hormones
Immunologic Factors
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists