Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)

NCT ID: NCT00537914

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 278 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-06
• Study Completion Date: 2022-03-25

Brief Summary

This study is performed 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).

Detailed Description

Prospective, open label, non-comparative, multicenter study. Short children born SGA were to be treated until they reached final height, but treatment could be discontinued earlier if medically indicated or if there was inadequate response to treatment.

Conditions

Small for Gestational Age

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Omnitrope

All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits.

Group Type: EXPERIMENTAL

Omnitrope

Intervention Type: DRUG

All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits.

Interventions

Omnitrope

All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits.

Intervention Type: DRUG

Other Intervention Names

Somatropin

Eligibility Criteria

Inclusion Criteria

• Pre-pubertal (Tanner stage I) children born SGA Boys: 4 years of age or older Girls: 4 years of age or older
• Growth disturbance defined as current height SDS < -2.5 (and parental adjusted SDS <-1) for chronological age and sex according to country specific references.
• Birth weight and/or length below -2 standard deviations (SD) for gestational age

Exclusion Criteria

• Onset of puberty
• Closed epiphyses
• Diabetes mellitus type I or type II
• Fasting blood glucose greater than 100 mg/dl or greater than 5.6 mmol/l measured in venous blood sample
• Abnormal findings in Oral Glucose Tolerance Test (OGTT) defined by greater than 140 mg/dl or greater than 7.8 mmol/l after 120 minutes
• Known IGF-I level above +2SD for sex and age
• Acute critical illness
• Previous treatment with any hGH preparation
• Treatment with antidiabetic medication (e.g. metformin, insulin)
• Drug abuse, substance abuse, or alcohol abuse

• Minimum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sandoz

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandoz Biopharmaceuticals

Role: STUDY_CHAIR

Sandoz GmbH

Locations

Sandoz Investigational Site

Edegem, Antwerpen, Belgium

Sandoz Investigational Site

Prague, Prague, Czechia

Sandoz Investigational Site

Hradec Králové, , Czechia

Sandoz Investigational Site

Ústí nad Labem, , Czechia

Sandoz Investigational Site

Tbilisi, , Georgia

Sandoz Investigational Site

Munich, Bavaria, Germany

Sandoz Investigational Site

Sankt Augustin, North Rhine-Westphalia, Germany

Sandoz Investigational Site

Szeged, Csongrád megye, Hungary

Sandoz Investigational Site

Budapest, , Hungary

Sandoz Investigational Site

Budapest, , Hungary

Sandoz Investigational Site

Győr, , Hungary

Sandoz Investigational Site

Miskolc, , Hungary

Sandoz Investigational Site

Poznan, Greater Poland Voivodeship, Poland

Sandoz Investigational Site

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Sandoz Investigational Site

Wroclaw, Lower Silesian Voivodeship, Poland

Sandoz Investigational Site

Rzeszów, Podkarpackie Voivodeship, Poland

Sandoz Investigational Site

Katowice, Silesian Voivodeship, Poland

Sandoz Investigational Site

Zabrze, Silesian Voivodeship, Poland

Sandoz Investigational Site

Gdansk, , Poland

Sandoz Investigational Site

Katowice, , Poland

Sandoz Investigational Site

Krakow, , Poland

Sandoz Investigational Site

Lodz, , Poland

Sandoz Investigational Site

Szczecin, , Poland

Sandoz Investigational Site

Warsaw, , Poland

Sandoz Investigational Site

Wroclaw, , Poland

Sandoz Investigational Site

Kielce, Świętokrzyskie Voivodeship, Poland

Sandoz Investigational Site

Cluj-Napoca, Cluj, Romania

Sandoz Investigational Site

Bucharest, , Romania

Sandoz Investigational Site

Bucharest, , Romania

Sandoz Investigational Site

Craiova, , Romania

Sandoz Investigational Site

Iași, , Romania

Countries

Belgium; Czechia; Georgia; Germany; Hungary; Poland; Romania

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2006-002506-58

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CEP00-401

Identifier Type: -

Identifier Source: org_study_id