Treatment of Children With Insufficient Secretion of Growth Hormone (BPLG-004)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by LG Life Sciences.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
BioPartners GmbH
Information provided by:
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT00271518
First received: December 29, 2005
Last updated: March 16, 2010
Last verified: March 2010
  Purpose

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


Condition Intervention Phase
Growth Hormone Deficiency (GHD)
Drug: growth hormone (somatropin)
Phase 3

LG Life Sciences has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy in Treatment Naive Children With Growth Failure Due to Insufficient Secretion of Endogenous Growth Hormone

Resource links provided by NLM:


Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • Height velocity at the end of 12 months treatment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 1.Height velocity SD score (HV SDS) after 12 months treatment, 2.Serum IGF-I levels3. Serum IGFBP-3 levels [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 144
Study Start Date: September 2005
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LB03002, sustained release human hGH
LB03002
Drug: growth hormone (somatropin)
dosing regimen is weight based.

Detailed Description:

Treatment with recombinant human growth hormone (somatropin) has been proven to be effective in stimulating height velocity and improving height in children with short stature due to insufficient endogenous Growth Hormone secretion. Currently somatropin is available in daily injection formulations. The requirement of daily administration causes significant burden and interruption of normal daily life. A product with less frequent dosing regimen will provide considerable improvement over currently available conventional replacement therapy regimens.

The primary objective of this study is to demonstrate the clinical comparability in terms of safety and efficacy of a new sustained release recombinant human growth hormone formulation to that of daily growth hormone.

  Eligibility

Ages Eligible for Study:   3 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Children with negative signs for intracranial tumour or tumour growth as confirmed with a CT or MRI scan (with contrast) within 12 months prior to inclusion or at inclusion visit
  • 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).
  • Height velocity (HV) of at least 1 SD (HV SDS £-1) below the mean HV for CA and sex according to the standards of Prader. The minimum time between two standard height measurements should be at least 6 month before inclusion.
  • 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.

Exclusion Criteria:

  • 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
  • The patient and/or the parent/legal guardian are likely to be non-compliant in respect to study conduct.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271518

Locations
United States, Pennsylvania
Division of Endocrinology, Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
LG Life Sciences
BioPartners GmbH
  More Information

No publications provided by LG Life Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Songmi Lee/Clinical Research Manager, LG Life Sciences
ClinicalTrials.gov Identifier: NCT00271518     History of Changes
Other Study ID Numbers: BPLG-004
Study First Received: December 29, 2005
Last Updated: March 16, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
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
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014