Long-term Safety Follow-up After Growth Hormone Treatment of Short Children Born Small for Gestational Age
NCT ID: NCT01491854
Last Updated: 2019-08-14
Study Results
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View full resultsBasic Information
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TERMINATED
NA
130 participants
INTERVENTIONAL
2009-07-20
2018-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Monitoring of long-term safety
Long-term safety follow-up after the end of treatment with Omnitrope (single arm)
Bloodsampling
Bloodsampling
Interventions
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Bloodsampling
Bloodsampling
Eligibility Criteria
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Inclusion Criteria
* Written informed consent of patient (for children who can read and/ or understand) and/or parent or legal guardian
Exclusion Criteria
4 Years
ALL
No
Sponsors
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Sandoz
INDUSTRY
Responsible Party
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Principal Investigators
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Sandoz Biopharmaceuticals Sandoz
Role: STUDY_CHAIR
Sandoz GmbH
Locations
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Novartis Investigative Site
Ústí nad Labem, Czech Republic, Czechia
Novartis Investigative Site
Hradec Králové, , Czechia
Novartis Investigative Site
Prague, , Czechia
Novartis Investigative Site
Tbilisi, , Georgia
Novartis Investigative Site
Nordrhein Westfalen, Sankt Augustin, Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Miskolc, , Hungary
Novartis Investigative Site
Poznai, Greater Poland Voivodeship, Poland
Novartis Investigative Site
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Novartis Investigative Site
Wroclaw, Lower Silesian Voivodeship, Poland
Novartis Investigative Site
Wroclaw, Lower Silesian Voivodeship, Poland
Novartis Investigative Site
Rzeszów, Podkarpackie Voivodeship, Poland
Novartis Investigative Site
Katowice, Silesian Voivodeship, Poland
Novartis Investigative Site
Zabrze, Silesian Voivodeship, Poland
Novartis Investigative Site
Gdansk, , Poland
Novartis Investigative Site
Krakow, , Poland
Novartis Investigative Site
Lodz, , Poland
Novartis Investigative Site
Szczecin, , Poland
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Kielce, Świętokrzyskie Voivodeship, Poland
Novartis Investigative Site
Lasi, Iaşi, Romania
Novartis Investigative Site
Bucharest, , Romania
Novartis Investigative Site
Cluj-Napoca, , Romania
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CEP00-402
Identifier Type: -
Identifier Source: org_study_id
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