|E.1 Medical condition or disease under investigation
|Medical condition(s) being investigated
|Growth hormone deficiency in adults
|E.1.2 Medical condition or disease under investigation
|Growth hormone deficiency
|Condition being studied is a rare disease
|E.2 Objective of the trial
|Main objective of the trial
|The objective of this rollover study is to evaluate the long term (1 year) safety of LB03002 in adults with GHD who were treated with LB03002 in study BPLG-005.
In addition, further changes in efficacy endpoints of BPLG-005 by prolonged treatment with LB03002 will be evaluated. Additional efficacy and safety data will be obtained from 6-month LB03002 treatment in the switch-over patients.
|Secondary objectives of the trial
|Trial contains a sub-study
|Principal inclusion criteria
|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.
|Principal exclusion criteria
|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.
|E.5 End points
|Primary end point(s)
The following safety endpoints will be measured in the patients on LB03002 during the BPLG-005 study to evaluate long-term safety of LB03002. In addition, the same endpoints will be measured in the patients on placebo during the BPLG-005 study to obtain additional 6-month safety profile of LB03002.
* Incidence of AEs;
* Incidence of anti-hGH antibody formation;
* Incidence of anti-Saccharomyces cerevisiae antibody formation;
* Local tolerability assessment by investigator and patient;
* Glucose homeostasis parameters (fasting glucose, fasting insulin and fasting HbA1c);
* Thyroid function tests (free T3, free T4, TSH);
* IGF-I SDS, IGF-I SDS minus IGFBP-3 SDS
* Adrenal function tests (serum cortisol, ACTH stimulation test);
* Safety laboratory parameters;
* Vital signs;
* Physical examination.
The within-group changes in the following efficacy endpoints from baseline of BPLG-005 to Visit 6 of BPLG-005-RO will be measured in the patients on LB03002 during the BPLG-005 study to evaluate long-term efficacy of LB03002. In addition, the within-group changes in the following endpoints from Visit 0 to Visit 6 of BPLG-005-RO will be measure in the patients on placebo during the BPLG-005 study to obtain additional 6-month efficacy of LB03002.
[Major efficacy variables]
* FM, LBM;
* QoL scores;
* Serum IGF-I level, IGF-I SDS;
* Total cholesterol.
[Other efficacy variables]
* Other body composition parameters:% body fat, trunk fat, % trunk fat;
* Waist-to-hip ratio;
* Serum IGFBP 3 level, IGFBP-3 SDS;
* Other lipid profile parameters: HDL cholesterol, LDL cholesterol, triglycerides.
|E.6 and E.7 Scope of the trial
|Scope of the trial
|Trial type and phase
|Human pharmacology (Phase I)
|First administration to humans
|Other trial type description
|Therapeutic exploratory (Phase II)
|Therapeutic confirmatory (Phase III)
|Therapeutic use (Phase IV)
|E.8 Design of the trial
| Comparator of controlled trial
|Other medicinal product(s)
The trial involves single site in the Member State concerned
| The trial involves multiple sites in the Member State concerned
|Number of sites anticipated in Member State concerned
|The trial involves multiple Member States
|Number of sites anticipated in the EEA
|E.8.6 Trial involving sites outside the EEA
|Trial being conducted both within and outside the EEA
|Trial being conducted completely outside of the EEA
| Information not present in EudraCT
|If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
|Trial has a data monitoring committee
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|E.8.9 Initial estimate of the duration of the trial
|In the Member State concerned years
|In the Member State concerned months
|In the Member State concerned days
|In all countries concerned by the trial years