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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01157793
• Date of registration: 06/07/2010
• Prospective Registration: No
• Primary sponsor: Merck KGaA
• Public title: 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
• Scientific title: A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in GHD Subjects During the Transition Phase From Childhood to Adulthood
• Date of first enrolment: September 2003
• Target sample size: 34
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01157793
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Contacts

• Name: Theodor Wee, MD
• Affiliation: Merck Serono International SA

Key inclusion & exclusion 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



Age minimum: 14 Years
Age maximum: 25 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Growth Hormone Deficiency

Dwarfism

Intervention(s)

Drug: r-hGH

Primary Outcome(s)

Change in percentage ejection fraction in subjects during the transition phase from childhood to adulthood [Time Frame: Baseline to study week 48]

Secondary Outcome(s)

Evaluation of laboratory parameters and monitoring of adverse events [Time Frame: Baseline to study week 48]

Subsidiary analysis of the other echocardiography parameters and lean body mass [Time Frame: Baseline to study week 48]

Secondary ID(s)

IMP24632

Source(s) of Monetary Support

Please refer to primary and secondary sponsors