Status:
COMPLETED
A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in Growth Hormone Deficient(GHD) Subjects During the Transition Phase From Childhood to Adulthood
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Dwarfism
Growth Hormone Deficiency
Eligibility:
All Genders
14-25 years
Phase:
PHASE4
Brief Summary
This was a 48-week, open-label, prospective, multicentric, randomised, comparative with parallel control, Phase 4 study to evaluate the effects of Saizen on cardiac function in GHD subjects during the...
Detailed Description
Growth hormone is a 191 amino acid polypeptide hormone (MW 22,000) normally synthesised and secreted by the somatotrophic cells of the anterior lobe of the pituitary gland. In normal development, grow...
Eligibility Criteria
Inclusion
- Subjects with diagnosis of childhood onset GH deficiency and previously treated with GH
- Subjects who had attained final height
- Male or female subjects, aged between 14 and 25 years of age inclusively at baseline
- Subjects with GH deficiency of \<5μg/L (acquired or idiopathic), established by any 1 type of GH secretion test within 3 years prior to Study Day 1
- If hypopituitary, subject must have been on adequate replacement therapy (if required) of glucocorticosteroids, thyroid \& sex hormones (hormones levels on replacement being in normal/mildly elevated range) for at least 6 months prior to study entry
- Subjects who were willing and able to comply with the protocol for the duration of the study.
- Subjects who had given written informed consent before any study-related procedure not part of the subject's normal medical care, with the understanding that the subject might withdraw consent at any time without prejudice to future medical care
- Female subjects must be neither pregnant nor breast-feeding, and use a hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study. Confirmation that a female subject was not pregnant was established by a negative urinary human chorionic gonadotropin (hCG) pregnancy test at baseline.
Exclusion
- Subject who had a known allergy or hypersensitivity to growth hormone or diluent
- Subject who had been treated with r-hGH in previous six months
- Subject with chronic severe kidney disease
- Subject with chronic severe liver disease
- Subject with acute or severe illness during the previous 6 months
- Subject with significant concomitant illness which would interfere with his/her participation or assessment in this study
- Subject with active malignancy (except non-melanomatous skin malignancies)
- Subjects with unstable hypertension (supine systolic blood pressure persistently above 160 mmHg or diastolic blood pressure persistently above 100 mmHg)
- Subjects with benign cranial hypertension
- Subjects with a history of carpal tunnel syndrome, unless surgically released
- Subjects with known positive human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg) and/or Hepatitis C virus (HCV) serology based on past medical history
- Subjects with known active drug addiction, including alcoholism, or use of drugs for nontherapeutic purposes
- Subject who had previously participated in this study
- Subject taking an investigational drug or enrolled in another clinical study
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01157793
Start Date
September 1 2003
End Date
February 1 2005
Last Update
July 11 2014
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