ong-term study on the safety and efficacy of Omnitrope® (rhGH) in short children born Small for Gestational Age

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

Inclusion Criteria

1. Pre-pubertal (Tanner stage I) children born SGA
• Boys: equal or above 4 years of age (bilateral testicular volume < 4 ml)
• Girls: equal or above 4 years of age (bilateral Tanner breast stage 1)
2. Growth disturbance defined as current height SDS < -2.5 (and parental adjusted SDS < -1) for chronological age and sex according to country specific references. If country specific references are not available, pre-defined published references will be used.
3. Birth weight and/or length below -2 SD for gestational age (according to country specific references). For the evaluation of gestational age, the date of the last menstrual period or ultrasonographic data obtained during the pregnancy should be used. If country specific references are not available, pre-defined published references will be used.
4. Height records between 18 months and 6 months prior to the start of GH treatment must be available.
5. Calculated height velocity SDS < 0 during the last year according to Prader 1989
6. Written informed consent of patient (for children who can read or understand) and parent or legal guardian

Are the trial subjects under 18? yes
Number of subjects for this age range: 50
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

Exclusion Criteria

1. Onset of puberty
2. Closed epiphyses
3. Diabetes mellitus type I or type II
4. Fasting blood glucose equal or above 100 mg/dl (5.6 mmol/l) measured in venous blood sample
5. Abnormal findings in OGTT defined by equal or above 140 mg/dl (7.8 mmol/l) after 120 minutes
6. Known IGF-I level above +2SD for sex and age
8. Acute critical illness e.g. suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure.
9. Known to be hepatitis B or hepatitis C positive or HIV-positive, known to have advanced diseases such as AIDS or tuberculosis
10. Any other disease, genetic disorder or malformation or treatment known to be associated with growth retardation, e.g. Turner or Noonan syndrome, Laron syndrome, Russell-Silver syndrome, Prader-Willi syndrome, skeletal dysplasias, chronic renal failure, cystic fibrosis, heart and liver diseases, malabsorption (coeliac disease), malnutrition, patients receiving radiation therapy of head or spinal cord
11. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
12. Known or suspected hypersensitivity to rhGH or any of the excipients (e.g. benzyl alcohol)
13. Previous treatment with any hGH preparation
14. Oral, inhalative or parenteral treatment with glucosteroids, except for physiological replacement, or hypothyroidism which has been left untreated, or was inadequately treated, or treated for less than 3 months
15. Treatment with LHRH / gonadotropin releasing hormone (GnRH) analoga (e.g. triptorelin)
16. Treatment with antidiabetic medication (e.g. metformin, insulin)
17. Drug abuse, substance abuse, or alcohol abuse
18. Known to be immunocompromised
19. Intake of growth promoting medication, e.g. anabolic steroids
20. Use of other investigational drugs within 30 days of enrolment
21. Patients unwilling and/or parents/guardians who are not capable of ensuring compliance with the provisions of the study protocol

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

ong-term study on the safety and efficacy of Omnitrope® (rhGH) in short children born Small for Gestational Age

Recruitment & Eligibility

Study & Design

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