A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.
- Conditions
- Growth hormone deficiency in adultsMedDRA version: 8.1Level: LLTClassification code 10056438Term: Growth hormone deficiency
- Registration Number
- EUCTR2006-002278-24-FR
- Lead Sponsor
- BioPartners GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 150
1) 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.
2) 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.
3) Written informed consent of the patient.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1) Evidence of active malignancy or growth of a previously stable tumor.
2) Benign intracranial hypertension.
3) Clinically significant respiratory, cardiac, hepatic, renal, neuromuscular disease.
4) Non-compliance with medications, un-cooperativeness or drug abuse during the BPLG-005 study.
5) Patients who are not able to comply with the study protocol for any reason.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method