Sustained Release Formulation of Somatropin (rDNA Origin)for Injection

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Brief Title

Sustained Release Formulation of Somatropin (rDNA Origin)for Injection

Official Title

A Phase II/IIIa, Assessor Blinded (Partially Blinded), Randomised, Active-Controlled, Multicentre, Parallel-Group Study of the Safety, Efficacy and pk/pd of LB03002 Administered Weekly in Children With Growth Failure Due to GH Deficiency.

Brief Summary

      Annualised height velocity after 12/24 months treatment and HV SDS height velocity after
      12/24 months treatment expressed as number of standard deviations difference from the mean
      population height velocity for the appropriate gender and chronological age.
    

Detailed Description

      To evaluate the safety, efficacy and pharmacokinetics/ pharmacodynamics of LB03002 in the
      treatment of growth failure in children with growth hormone deficiency (GHD) and to determine
      the dose for a subsequent phase IIIb BPLG-004 study
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Annualised HV after 12/24 months treatment and HV SDS height velocity

Secondary Outcome

 HVSDS, HTG, HTSD, bone maturation (BM), IGF-I, IGFBP-3

Condition

Growth Hormone Deficiency

Intervention

BPLG-003


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

51

Start Date

June 2003

Completion Date

June 2006


Eligibility Criteria

        Inclusion Criteria:

          -  Confirmed diagnosis of GHD as determined by two different GH provocation tests
             documenting deficient GH secretion, defined as a peak plasma GH level of less than 7
             ng/mL and absence of any peak plasma GH level in the spontaneous growth hormone
             secretion above 7 ng/mL monitored 3 hours before the application of the
             pharmacological stimuli at least before one stimulation test.

          -  Pre-pubertal children (boys age: 4-10 years or girls: age 4-9 years) with primary
             (idiopathic) and secondary (organic) insufficiency of growth hormone secretion.

          -  Children with negative signs for intracranial tumour or tumour growth as confirmed
             with Computer tomography (CT) or magnetic resonance imaging (MRI) scan within 12
             months prior to inclusion or within 6 months prior to inclusion of children with GH
             insufficiency occurred after treatment for any brain tumour. Such patients have to be
             at least 24 months into full clinical remission.

          -  No prior exposure to rhGH (GH-naïve)

          -  Height (HT) of at least 2.0 standard deviation (SD) (HT SDS ≤2.0) below the mean
             height for chronological age (CA) and sex according to the Standards of Prader et
             al15.

          -  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 et al15.

          -  Baseline IGF-I level standardized for age and sex less than -1.0 SDS

          -  Bone age (BA) ≤9 years for boys and ≤ 8 years for girls,

          -  For children with multiple hormonal deficiencies, stabilized on replacement therapies
             for other pituitary axes (e.g. thyroid-stimulating hormone, adrenocorticotropic
             hormone/cortisol and vasopressin) for at least 3 months and 6 months for thyroid
             replacement therapy prior to enrolment for children with multiple hormonal
             deficiencies.

          -  Written informed consent of parent or legal guardian of subject.

        Exclusion Criteria:

          -  The result of the 3 hours spontaneous GH peak is equal to, or above 7 ng/ml. The value
             of the peak GH level in case of repeated pharmacology test is below 7 ng/ml, whilst
             the 6 hours spontaneous peak GH is above this value,

          -  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, diabetes mellitus and malnutrition (BMI must be above -2SD and below
             +2SD of mean BMI for the chronological age and sex, and albumin must be above lower
             limit of normal (LLN) of the central laboratory for a patient to be included),
             Chromosomal abnormalities and medical "syndromes", with the exception of
             holoprosencephaly/septo-optic dysplasia (Turner's syndrome, Laron syndrome, Noonan
             syndrome or absence of growth hormone receptors).

          -  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 micro gram/day of budesonide or equivalents inhaled for longer than 1 month
             during a year,

          -  Poorly controlled pituitary insufficiencies of other axes (e.g., thyroid-stimulating
             hormone, adrenocorticotropic hormone/cortisol, vasopressin-deficiency), 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 in
             remission for less than one year At screening, presence of anti-hGH antibodies

          -  The patient and/or the parent/legal guardian are likely to be non-compliant in respect
             to study conduct.
      

Gender

All

Ages

4 Years - 10 Years

Accepts Healthy Volunteers

No

Contacts

Ference Peter, MD, , 



Administrative Informations


NCT ID

NCT00600808

Organization ID

BPLG-003



Study Sponsor

BioPartners GmbH

Collaborators

 LG Life Sciences

Study Sponsor

Ference Peter, MD, Principal Investigator, BUDA Children's Hospital, Budapest


Verification Date

July 2007