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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00596037 |
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Date of registration:
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07/01/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment of Adults With Growth Hormone Deficiency
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Scientific title:
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A Phase III, Open-label, Uncontrolled, Multicentre, Rollover Study to Assess Safety and Efficacy of LB03002 Administered Weekly in Adults With Growth Hormone Deficiency |
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Date of first enrolment:
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August 2006 |
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Target sample size:
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136 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00596037 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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HJ Ji, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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LG Life Sciences |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients (male and female) who have completed the Visit 8 of preceding main study
(BPLG-005) and are willing to continue their participation in an extension study
- If female, women of child-bearing potential who are using a reliable method of
contraception and be willing to use it throughout the study. A negative urine
pregnancy test at Visit 0 is required for females of child-bearing potential
- Written informed consent of the patient
Exclusion Criteria:
- Evidence of active malignancy or growth of a previously stable tumor
- Benign intracranial hypertension
- Clinically significant respiratory, cardiac, hepatic, renal, neuromuscular disease
- Non-compliance with medications, un-cooperativeness or drug abuse during the BPLG-005
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
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Health Condition(s) or Problem(s) studied
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Adult Growth Hormone Deficiency
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Pituitary Disorders
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Intervention(s)
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Drug: Growth hormone - LB03002
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Primary Outcome(s)
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Incidence of adverse events, antibody formation and local tolerability assessment after 1 year treatment from baseline of BPLG-005
[Time Frame: 1 year]
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Secondary ID(s)
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BPLG-005-RO
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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