Treatment of Adults With Growth Hormone Deficiency

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00294619
• Date of registration: 20/02/2006
• Prospective Registration: Yes
• Primary sponsor: LG Life Sciences
• Public title: Treatment of Adults With Growth Hormone Deficiency
• Scientific title: A Phase III, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess Efficacy and Safety of LB03002 Administered Weekly in Adults With Growth Hormone Deficiency.
• Date of first enrolment: April 2006
• Target sample size: 147
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00294619
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: HJ Ji, PhD
• Affiliation: LG Life Sciences

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female of at least 23 years and not more than 70 years of age

- GHD of either adult onset(AO)or Childhood onset(CO), either idiopathic or secondary
to pituitary disease

- Confirmed diagnosis of GHD defined

- IGF-1 SDS = -1 at screening

- No exposure to rhGH within the last 6 months

- Patients with adequate adrenal function, which is confirmed by ACTH stimulation test
at screening; or Patients with known secondary hypoadrenalism on adequate
glucocorticoid replacement therapy

- If applicable, hormone replacement therapies for any other hormone deficiencies,
adequate and stable for at least 3 months before study entry

- Women of child-bearing potential to be using a reliable method of contraception at
the screening and be willing to use it throughout the study

- A negative serum pregnancy test is required at screening for females of child-bearing
potential.

Exclusion Criteria:

- History of malignancy other than cranial tumor or leukemia causing GHD or fully
treated basal cell carcinoma

- Evidence of active malignancy

- Evidence of growth of pituitary adenoma or other intracranial tumor within the last
12 months, or patients without MRI or CT data to confirm the tumor stability within
the last 12 months

- Significant hepatic dysfunction

- Chronic renal impairment

- Clinically significant pulmonary, cardiac, hepatic, renal, or neuromuscular disease

- Prader-Willi syndrome

- Acute severe illness in the last 6 months

- Benign intracranial hypertension

- Active Cushing's syndrome within the last 12 months

- Uncontrolled hypertension

- Patients with overt diabetes mellitus or evidence of persistent impaired glucose
tolerance

- Severe psychiatric disease or patients who cannot understand the objective and
methods of the study or patients with current alcohol abuse

- Pregnancy or lactation

- Known hypersensitivity to any ingredient of the study drug

- Inability to undergo scanning by dual-energy X ray absorptiometry (DXA) due to a body
weight more than 130 kg or in situ internal or external devices known to interfere
with DXA scanning

- Weight reducing drugs or appetite suppressants

- Anabolic steroids other than gonadal steroid replacement therapy within 2 months
before study entry

- Methylphenidate within 2 months before study entry

- Systemic corticosteroids other than in replacement doses within the 3 months before
study entry.

- History of non-compliance with medications, un-cooperativeness or drug abuse

- Patients participating in another study parallel to, or within 6 months prior to
study entry, or previous participation in this study

- Patients who are not able to comply with the study protocol for any reason.



Age minimum: 23 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Pituitary Disorders

Adult Growth Hormone Deficiency

Intervention(s)

Drug: growth hormone

Primary Outcome(s)

Changes in Fat Mass at the end of 26-week treatment from baseline [Time Frame: 26 weeks]

Secondary Outcome(s)

Changes in the following parameters at the end of 26-week treatment from baseline; other body composition parameters, QoL Score, Serum IGF-I, IGFBP-3 levels & SDS, Lipid profile, waist-to-hip ratio [Time Frame: 26 weeks]

Secondary ID(s)

BPLG-005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

BioPartners GmbH