Long-term Safety Follow-up After Growth Hormone Treatment of Short Children Born Small for Gestational Age (SGA)
This study is currently recruiting participants.
Verified December 2011 by Sandoz
Sponsor:
Sandoz
Information provided by (Responsible Party):
Sandoz
ClinicalTrials.gov Identifier:
NCT01491854
First received: December 12, 2011
Last updated: December 13, 2011
Last verified: December 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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
- 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
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 May 21, 2013