Treatment of Children With Insufficient Secretion of Growth Hormone

NCT00271518 | Unknown Phase 3 DMC

• 1 other identifier: BPLG-004
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare a new weekly administered growth hormone preparation with standard daily treatment in children with insufficient secretion of growth hormone

Conditions

Growth Hormone Deficiency (GHD)

Outcome Measures

Primary Outcomes (1)

• Height velocity at the end of 12 months treatment

  12 months

Secondary Outcomes (1)

• 1.Height velocity SD score (HV SDS) after 12 months treatment, 2.Serum IGF-I levels3. Serum IGFBP-3 levels

  12 months

Study Arms (1)

LB03002, sustained release human hGH

EXPERIMENTAL

LB03002

Drug: growth hormone (somatropin)

Interventions

growth hormone (somatropin) DRUG

dosing regimen is weight based.

LB03002, sustained release human hGH

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pre-pubertal children (boys age: \> 3 and \<12 years or girls: age \>3 and \<11 years) with isolated GH insufficiency, GH insufficiency as part of multiple pituitary hormone deficiencies, or organic GH insufficiency. If GH insufficiency occurred after treatment for any brain tumour, the patient has to be at least one year in clinical remission which has to be confirmed by computer tomography (CT) or magnetic resonance imaging (MRI) scan (with contrast) within 3 months prior to study entry
• Confirmed diagnosis of GH insufficiency as determined by two different GH provocation tests, defined as a peak plasma GH level of ≤7 ng/ml
• No prior exposure to rhGH therapy (GH-treatment naive)
• Height (HT), except in children suffering from organic GH insufficiency, of at least 2.0 standard deviations (SD) (HT SDS £-2.0) below the mean height for chronological age (CA) and sex according to the 2000 standards from the Centers for Disease Control and Prevention (CDC).
• Baseline IGF-I level of at least 0.5 SD (IGF-1 SDS£-0.5) below the mean IGF-1 level standardised for age and sex according to the central laboratory reference values.
• Written informed consent of parent or legal guardian of subject.

You may not qualify if:

• Any clinically significant abnormality likely to affect growth or the ability to evaluate growth, such as, but not limited to, chronic diseases like renal insufficiency, spinal cord irradiation, and malnutrition (BMI must be above -2SD and below +2SD of mean BMI for the chronological age and sex according to the CDC standards, and albumin must be above lower limit of normal (LLN) of the central laboratory for a patient to be included).
• Patients with overt diabetes mellitus (Fasting blood sugar \>126 mg/dl) and impaired fasting sugar (Fasting blood sugar \>100 mg/dl after repeated blood analysis)
• Chromosomal abnormalities and medical "syndromes" (Turner's syndrome, Laron syndrome, Noonan syndrome or absence of growth hormone receptors), with the exception of septo-optic dysplasia
• Congenital abnormalities (causing skeletal abnormalities), Russell-Silver Syndrome, skeletal dysplasias
• Closed epiphyses
• Other growth promoting medication such as anabolic steroids, with the exception of pituitary hormone replacement therapy, thyroxine, hydrocortisone and desmopressin (DDAVP) replacement therapies
• Children requiring glucocorticoid therapy (e.g. asthma) that are on the dose of more than 400 µg/d of inhaled budesonide or equivalents inhaled for longer than 1 month during a calendar year
• Bone age (BA) higher than chronological age
• Poorly controlled or uncontrolled pituitary insufficiencies of other axes (e.g., thyroid-stimulating hormone, adrenocorticotropic hormone/cortisol, vasopressin deficiency): Children who are on stable replacement therapy for less than 6 months for thyroid replacement therapy, and less than 3 months for other hormonal deficiencies prior to enrolment
• Major medical conditions and/or presence of contraindication to rhGH treatment
• Known or suspected HIV-positive patient or patient with advanced diseases such as AIDS or tuberculosis
• Drug, substance, or alcohol abuse
• Known hypersensitivity to the components of study medication
• Evidence of tumour growth or malignant disease
• Presence of anti-hGH antibodies at screening

Sponsors & Collaborators

• LG Life Sciences: lead
• BioPartners GmbH: collaborator

Study Sites (1)

Division of Endocrinology, Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Location

Related Publications (1)

• Khadilkar V, Radjuk KA, Bolshova E, Khadgawat R, El Kholy M, Desai M, Peterkova V, Mericq V, Kratzsch J, Siepl EC, Martin D, Lopez P, Ji HJ, Bae YJ, Lee JH, Saenger PH. 24-month use of once-weekly GH, LB03002, in prepubertal children with GH deficiency. J Clin Endocrinol Metab. 2014 Jan;99(1):126-32. doi: 10.1210/jc.2013-2502. Epub 2013 Dec 20.

  PMID: 24170106 DERIVED

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Growth Hormone; Human Growth Hormone

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Expanded Access: Yes

Study Record Dates

• First Submitted: December 29, 2005
• First Posted: January 2, 2006
• Study Start: September 1, 2005
• Primary Completion: December 1, 2013
• Last Updated: March 17, 2010

Record last verified: 2010-03

Locations

US (1)