A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. - BPLG-005-RO

Active, not recruiting

• Conditions: Growth hormone deficiency; MedDRA version: 9.1Level: HLTClassification code 10002701Term: Anterior pituitary hypofunction

• Registration Number: EUCTR2006-002278-24-IT
• Lead Sponsor: BIOPARTNERS GMBH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 150

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) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;Secondary Objective: 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.;Primary end point(s): &amp;#61548;Incidence of adverse events;<br>&amp;#61548;Fat mass (FM);<br>&amp;#61548;Lean body mass (LBM);<br>&amp;#61548;QoL score;<br>&amp;#61548;Serum insulin-like growth factor-I (IGF-I), IGF-I standard deviation score (SDS);<br>&amp;#61548;Total cholesterol.<br>&amp;#61548;Body composition parameters: % body fat, trunk fat, % trunk fat;<br>&amp;#61548;Waist-to-hip ratio;<br>&amp;#61548;Serum insulin-like growth factor binding protein-3 (IGFBP-3), IGFBP-3 SDS;