E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Growth hormone deficiency in adults |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10056438 |
E.1.2 | Term | Growth hormone deficiency |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | 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. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | 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.
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E.4 | Principal exclusion criteria |
1) Evidence of active malignancy or growth of a previously stable tumor. 2) Benign intracranial hypertension. 3) 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. (footnote: An additional MRI or CT scan will be conducted to confirm the tumor stability if a patient meets other inclusion and exclusion criteria, but DOES NOT have MRI or CT date within last 12 months to confirm th etumor stbility.) 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety endpoints: 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.
Efficacy endpoints 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 29 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |