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

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: All

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 transition phase from childhood to adulthood.

The study was designed to evaluate whether recombinant-human growth hormone (r-hGH) treatment also benefits young subjects with GHD. Some trials have already been published on this subject, but they were mainly focused on the bone density.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Hormones

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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