A Phase III, Open-label, Uncontrolled, Multicentre, Rollover Study to Assess Safety and Efficacy of LB03002 Administered Weekly in Adults With Growth Hormone Deficiency
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 136
- Primary Endpoint
- Incidence of adverse events, antibody formation and local tolerability assessment after 1 year treatment from baseline of BPLG-005
Study Overview
Brief Summary
The objective of this rollover study is to evaluate the long term (1 year) safety of a new weekly administered growth hormone preparation in adults with growth hormone deficiency who were treated with the same experimental preparation in study BPLG-005. In addition, further change in efficacy endpoints of BPLG-005 by prolonged treatment will be evaluated. Additional efficacy and safety data of the experimental preparation will be obtained from the switch-over patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 23 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
LB03002 throughout
administered LB03002 for preceding 26 weeks
Intervention: Growth hormone - LB03002 (Drug)
Switched to LB03002
administered placebo for preceding 26 weeks
Intervention: Growth hormone - LB03002 (Drug)
Outcomes
Primary Outcomes
Incidence of adverse events, antibody formation and local tolerability assessment after 1 year treatment from baseline of BPLG-005
Time Frame: 1 year
Secondary Outcomes
No secondary outcomes reported