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 September 2014 by Sandoz
Sponsor:
Information provided by (Responsible Party):
Sandoz
ClinicalTrials.gov Identifier:
NCT01491854
First received: December 12, 2011
Last updated: March 11, 2015
Last verified: September 2014
  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
Short Children Born Small for Gestational Age (SGA)
Other: Bloodsampling

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
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 long-term safety
Long-term safety follow-up after the end of treatment with Omnitrope (single arm)
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
Sandoz Investigational Site Recruiting
Hradec Králové, Czech Republic
Sandoz Investigational Site Recruiting
Prague, Czech Republic
Sandoz Investigational Site Recruiting
Ústí nad Labem, Czech Republic
Georgia
Sandoz Investigational Site Recruiting
Tiblisi, Georgia
Germany
Sandoz Investigational Site Recruiting
Munich, Germany
Sandoz Investigational Site Recruiting
Sankt Augustin, Germany
Hungary
Sandoz Investigational Site Recruiting
Budapest, Hungary
Sandoz Investigational Site Recruiting
Györ, Hungary
Sandoz Investigational Site Recruiting
Miskolc, Hungary
Sandoz Investigational Site Recruiting
Szeged, Hungary
Poland
Sandoz Investigational Site Recruiting
Bydgoszcz, Poland
Sandoz Investigational Site Recruiting
Gdańsk, Poland
Sandoz Investigational Site Recruiting
Katowice, Poland
Sandoz Investigational Site Recruiting
Kielce, Poland
Sandoz Investigational Site Recruiting
Kraków, Poland
Sandoz Investigational Site Recruiting
Lódz, Poland
Sandoz Investigational Site Recruiting
Poznań, Poland
Sandoz Investigational Site Recruiting
Rzeszów, Poland
Sandoz Investigational Site Recruiting
Szczecin, Poland
Sandoz Investigational Site Recruiting
Warszawa, Poland
Sandoz Investigational Site Recruiting
Wroclaw, Poland
Sandoz Investigational Site Recruiting
Wrocław, Poland
Sandoz Investigational Site Recruiting
Zabrze, Poland
Romania
Sandoz Investigational Site Recruiting
Bucharest, Romania
Sandoz Investigational Site Recruiting
Cluj Napoca, Romania
Sandoz Investigational Site Recruiting
Craiova, Romania
Sandoz Investigational Site Recruiting
Iasi, 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: March 11, 2015
Health Authority: Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Georgia: Ministry of Health
Georgia: Ethics Committee
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

ClinicalTrials.gov processed this record on April 23, 2015