A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-002278-24-DE

Enrollment

150

Registered

2006-08-15

Start date

2006-10-06

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth hormone deficiency in adults MedDRA version: 8.1 Level: LLT Classification code 10056438 Term: Growth hormone deficiency

Interventions

Product Code: LB03002 Pharmaceutical Form: Powder and solvent for suspension for injection INN or Proposed INN: somatropin CAS Number: 12629-01-5 Current Sponsor code: LB03002 Other descriptive name:

Eligibility

Sex/Gender

All

Inclusion criteria

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. 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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 Objective: none.;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,	—

Measure

Time frame

Main Objective: 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 Objective: none.;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,

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Countries

Austria, Czech Republic, France, Germany, Italy, Spain, Sweden, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026