NCT00537914

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_4

Geographic Reach
7 countries

31 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

February 6, 2008

Completed
14.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2022

Completed
2 years until next milestone

Results Posted

Study results publicly available

March 12, 2024

Completed
Last Updated

March 12, 2024

Status Verified

August 1, 2023

Enrollment Period

14.1 years

First QC Date

October 1, 2007

Results QC Date

September 20, 2022

Last Update Submit

August 16, 2023

Conditions

Small for Gestational Age

Keywords

Small for Gestational Age, Omnitrope®/Somatropin, rhGH,SGA

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Development of Diabetes in Short Children Born SGA During Treatment

    The development of diabetes in short children born SGA during treatment was evaluated based on the carbohydrate metabolism parameters FPG, HbA1c and OGTT (basal and 2-h plasma glucose). Only cases which were confirmed by the investigator were included.

    throughout the study, approximately 13 years

Secondary Outcomes (7)

  • Mean Change in Height (H) (cm) From Baseline

    Baseline, 3 months, 1 year, 2 years, 5 years and 9 years

  • Mean Change in Height Standard Deviation Score Over Time From Baseline

    Baseline, 3 months, 0.5 year, 9 months, 1 year, 1.25 years, 1.5 years, 1.75 years, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years, 11 years, 12 years, 12.5 years

  • Mean Change in Height Velocity (HV) (cm/Year) Over Time From Baseline

    Baseline, 3 months, 1 year, 2 years, 5 years and 9 years

  • Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline

    Baseline, 3 months, 0.5 year, 9 months, 1 year, 1.25 years, 1.5 years, 1.75 years, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years, 11 years, 12 years, 12.5 years

  • Mean Change in Serum IGF-1 Level (Nmol/L) From Baseline

    Baseline, 3 months, 1 year, 2 years, 5 years and 9 years

  • +2 more secondary outcomes

Study Arms (1)

Omnitrope

EXPERIMENTAL

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.

Drug: Omnitrope

Interventions

OmnitropeDRUG

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.

Also known as: Somatropin
Omnitrope

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Sandoz Investigational Site

Edegem, Antwerpen, 2650, Belgium

Location

Sandoz Investigational Site

Prague, Prague, 150 06, Czechia

Location

Sandoz Investigational Site

Hradec Králové, 500 05, Czechia

Location

Sandoz Investigational Site

Ústí nad Labem, 400 11, Czechia

Location

Sandoz Investigational Site

Tbilisi, 144, Georgia

Location

Sandoz Investigational Site

Munich, Bavaria, 80337, Germany

Location

Sandoz Investigational Site

Sankt Augustin, North Rhine-Westphalia, 53757, Germany

Location

Sandoz Investigational Site

Szeged, Csongrád megye, 6720, Hungary

Location

Sandoz Investigational Site

Budapest, 1023, Hungary

Location

Sandoz Investigational Site

Budapest, 1094, Hungary

Location

Sandoz Investigational Site

Győr, 9024, Hungary

Location

Sandoz Investigational Site

Miskolc, 3526, Hungary

Location

Sandoz Investigational Site

Poznan, Greater Poland Voivodeship, 60-572, Poland

Location

Sandoz Investigational Site

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-667, Poland

Location

Sandoz Investigational Site

Wroclaw, Lower Silesian Voivodeship, 50-368, Poland

Location

Sandoz Investigational Site

Rzeszów, Podkarpackie Voivodeship, 35-301, Poland

Location

Sandoz Investigational Site

Katowice, Silesian Voivodeship, 40-752, Poland

Location

Sandoz Investigational Site

Zabrze, Silesian Voivodeship, 41-800, Poland

Location

Sandoz Investigational Site

Gdansk, 80-952, Poland

Location

Sandoz Investigational Site

Katowice, 40-752, Poland

Location

Sandoz Investigational Site

Krakow, 30-663, Poland

Location

Sandoz Investigational Site

Lodz, 93-338, Poland

Location

Sandoz Investigational Site

Szczecin, 71-252, Poland

Location

Sandoz Investigational Site

Warsaw, 04-730, Poland

Location

Sandoz Investigational Site

Wroclaw, 51-312, Poland

Location

Sandoz Investigational Site

Kielce, Świętokrzyskie Voivodeship, 25734, Poland

Location

Sandoz Investigational Site

Cluj-Napoca, Cluj, 400370, Romania

Location

Sandoz Investigational Site

Bucharest, 011461, Romania

Location

Sandoz Investigational Site

Bucharest, 020395, Romania

Location

Sandoz Investigational Site

Craiova, 200642, Romania

Location

Sandoz Investigational Site

Iași, 700111, Romania

Location

MeSH Terms

Interventions

Human Growth Hormone

Intervention Hierarchy (Ancestors)

Growth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Clinical Disclosure Representative
Organization
Sandoz
sandoz.disclosure@sandoz.com
+4980249080

Study Officials

  • Sandoz Biopharmaceuticals

    Sandoz GmbH

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2007

First Posted

October 2, 2007

Study Start

February 6, 2008

Primary Completion

March 25, 2022

Study Completion

March 25, 2022

Last Updated

March 12, 2024

Results First Posted

March 12, 2024

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Locations

HU(5)PL(14)RO(5)CZ(3)DE(2)GE(1)BE(1)