Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardatio
- Conditions
- Growth Disorders, Intrauterine Growth RetardationTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2014-004160-38-Outside-EU/EEA
- Lead Sponsor
- KABI PHARMACIA S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 206
1.Chronological age (CA) between 3 and 10 years for girls.
2.Chronological age between 3 and 12 years for boys.
3.Height for CA below - 2 standard deviation (SD).
4.Height velocity for chronological age below 0 SD based on 9 to 15 months observation period before inclusion.
5.Birth weight known.
6.Birth length for gestational age below - 2 SD.
7.Gestational age known.
8.Prepubertal stage (Boys): Testosterone less than or equal to (<=) 0.30 nanogram per milliliter (ng/mL), Testis volume <=2 mL; Prepubertal stage (Girls): Pelvis echography : no sign of puberty, Uterus length =<30 millimeter (mm), Breast development 9.Bone age done within 3 months prior to study entry.
10.A provocation test giving a growth hormone (GH) level >=10 ng/mL.
11.Known parental height.
12.Signed written informed consent obtained from the patient's parent/guardian.
Are the trial subjects under 18? yes
Number of subjects for this age range: 206
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Endocrine disease except well-substituted hypothyroidism.
2.Sever chronic disease(example [e.g.] diabetes mellitus, renal or liver disease).
3.Skeletal dysplasia.
4.Known chromosomal aberration.
5.Previous irradiation therapy
6.Ongoing pharmacological treatment with steroids.
7.Known intrauterine infection.
8.Microcephaly, defined as head circumference below -2 SD.
9.Previous treatment with GH or GH-releasing hormone [RH]
10.Subjects who have known or suspected allergy to the preservative m-cresol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effect of continuous and intermittent administration of Genotonorm 16 international unit (IU) on stature in prepubertal short children with intra-uterine growth retardation (IUGR) as measured by height velocity (centimetre [cm]/year) at 24 months.;Secondary Objective: Evaluation of the effect of 3 treatment regimens on height at 3 years (using height standard deviation score [SDS]). Evaluate the safety of 3 treatment regimens as measured by clinical and laboratory parameters.;Primary end point(s): Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm;Timepoint(s) of evaluation of this end point: Baseline, 2 years
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) Annual Growth Rate Standard Deviation Score (SDS)<br>2) Change From Baseline in Annual Growth Rate SDS<br>3) Height (cm)<br>4) Change From Baseline in Height (cm)<br>5) Height (SDS)<br>6) Change From Baseline in Height (SDS)<br>7) Body Mass Index (BMI)<br>8) Weight<br>9) Change From Baseline in Bone Age <br>10) Change From Baseline in Bone Age/Change From Baseline in Chronological Age Ratio<br>11) Chronological Age at Onset of Puberty<br>12) Number of Subjects Reaching Puberty;Timepoint(s) of evaluation of this end point: 1) Baseline, 1 to 6 years<br>2) Baseline, 1 to 3 years<br>3) Baseline, 1 to 6 years, final height<br>4) Baseline, 1 to 6 years, final height<br>5) Baseline, 1 to 6 years, final height<br>6) Baseline, 1 to 6 years, final height<br>7) Baseline, 1 to 6 years<br>8) Baseline, 1 to 6 years<br>9) Baseline, 1 to 3 years<br>10) 1 to 3 years<br>11) Onset of puberty<br>12) Baseline, 1 to 6 years<br>