Long-term Safety Follow-up After Growth Hormone Treatment of Short Children Born Small for Gestational Age (SGA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2011 by Sandoz
Sponsor:
Information provided by (Responsible Party):
Sandoz
ClinicalTrials.gov Identifier:
NCT01491854
First received: December 12, 2011
Last updated: December 13, 2011
Last verified: December 2011
  Purpose

This study is performed as part of the Marketing Authorisation Holder's post-marketing pharmacovigilance plan to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (SGA).


Condition Intervention Phase
Small for Gestational Age (SGA)
Other: Bloodsampling
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Official Title: Long-term Safety Follow-up After Growth Hormone Treatment (rhGH) of Short Children Born Small for Gestational Age (SGA)

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Evaluate the long-term effect of growth hormone treatment on the development of diabetes after end of therapy. [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
    The primary objective of this study is to evaluate the long-term effect of growth hormone treatment on the development of diabetes in short children born SGA for 10 years after the end of treatment.


Secondary Outcome Measures:
  • To evaluate the incidence of anti-rhGH antibodies and anit-HCP antibodies after 6 months after termination of growth hormone treatment. [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

    The secondary objectives of this study are:

    • to report the incidence of anti-rhGH antibodies and of E. coli host cell peptide (HCP) antibodies (ABs) 6 months after termination of growth hormone treatment.
    • to evaluate final height in follow-up period
    • to evaluate IGF-I and IGFBP-3 levels for 10 years after end of growth hormone treatment
    • to evaluate incidence and severity of adverse events


Estimated Enrollment: 200
Study Start Date: November 2009
Estimated Study Completion Date: July 2031
Estimated Primary Completion Date: July 2031 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Monitoring of safety
Safety follow-up after the end of treatment with Omnitrope (single group)
Other: Bloodsampling
Bloodsampling

Detailed Description:

The purpose of this study is

  1. to monitor short children born SGA who were treated with growth hormone in study EP00-401 for the development of diabetes for a further 10 years after termination of growth hormone treatment

    and

  2. to report the incidence of anti-rhGH antibodies and of E. coli host cell peptide (HCP) antibodies (ABs) for 6 months after termination of GH treatment.
  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients who fulfilled the diagnosis SGA, participated in study EP00-401, and received at least one dose of study medication
  • Written informed consent of patient (for children who can read and/ or understand) and/or parent or legal guardian

Exclusion Criteria:

  • Patients unwilling and/or parents/guardians who are not capable of ensuring compliance with the provisions of the study protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491854

Contacts
Contact: Sandoz Biopharmaceuticals +49 8024 908 ext 0

Locations
Czech Republic
Recruiting
Prague, Czech Republic
Georgia
Recruiting
Tiblisi, Georgia
Germany
Recruiting
St. Augustin, Germany
Hungary
Recruiting
Budapest, Hungary
Poland
Recruiting
Szczencin, Poland
Romania
Recruiting
Bucharest, Romania
Sponsors and Collaborators
Sandoz
Investigators
Study Chair: Sandoz Biopharmaceuticals Sandoz Sandoz GmbH
  More Information

No publications provided

Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01491854     History of Changes
Other Study ID Numbers: EP00-402
Study First Received: December 12, 2011
Last Updated: December 13, 2011
Health Authority: Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Georgia: Ministry of Health
Georgia: Ethics Commission
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Hungary: Institutional Ethics Committee
Hungary: National Institute of Pharmacy
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: Ethics Committee
Romania: National Medicines Agency

Keywords provided by Sandoz:
Long-term
safety
follow-up
growth hormone treatment
short children
Small for Gestational Age
Somatropin

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014