Treatment of Children With Insufficient Secretion of Growth Hormone

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Brief Title

Treatment of Children With Insufficient Secretion of Growth Hormone

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

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
    

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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Height velocity at the end of 12 months treatment

Secondary Outcome

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

Condition

Growth Hormone Deficiency (GHD)

Intervention

growth hormone (somatropin)

Study Arms / Comparison Groups

 LB03002, sustained release human hGH
Description:  LB03002

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

144

Start Date

September 2005


Primary Completion Date

December 2013

Eligibility 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.
      

Gender

All

Ages

3 Years - 11 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00271518

Organization ID

BPLG-004



Study Sponsor

LG Life Sciences

Collaborators

 BioPartners GmbH

Study Sponsor

, , 


Verification Date

March 2010