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

NCT01157793 | Completed Phase 4

• 1 other identifier: IMP24632
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Dwarfism; Growth Hormone Deficiency

Keywords

Dwarfism; Growth hormone deficiency; Growth hormone

Outcome Measures

Primary Outcomes (1)

• Change in percentage ejection fraction in subjects during the transition phase from childhood to adulthood

  Baseline to study week 48

Secondary Outcomes (2)

• Subsidiary analysis of the other echocardiography parameters and lean body mass

  Baseline to study week 48

• Evaluation of laboratory parameters and monitoring of adverse events

  Baseline to study week 48

Study Arms (2)

Group 1

EXPERIMENTAL

Drug: r-hGH

Group 2

EXPERIMENTAL

Drug: r-hGH

Interventions

r-hGH DRUG

r-hGH at a dose of 0.15-1.00 mg/day administered for 48 weeks by s.c. route

Also known as: Saizen®

Group 1

Eligibility Criteria

• Age: 14 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

MeSH Terms

Conditions

Dwarfism; Dwarfism, Pituitary

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Theodor Wee, MD

  Merck Serono International SA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 6, 2010
• First Posted: July 7, 2010
• Study Start: September 1, 2003
• Primary Completion: February 1, 2005
• Study Completion: February 1, 2005
• Last Updated: July 11, 2014

Record last verified: 2010-07