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Treatment of Adults With Growth Hormone Deficiency

Primary Purpose

Pituitary Disorders, Adult Growth Hormone Deficiency

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Growth hormone - LB03002
Sponsored by
LG Life Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pituitary Disorders focused on measuring Growth hormone Deficiency

Eligibility Criteria

23 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    LB03002 throughout

    Switched to LB03002

    Arm Description

    administered LB03002 for preceding 26 weeks

    administered placebo for preceding 26 weeks

    Outcomes

    Primary Outcome Measures

    Incidence of adverse events, antibody formation and local tolerability assessment after 1 year treatment from baseline of BPLG-005

    Secondary Outcome Measures

    Full Information

    First Posted
    January 7, 2008
    Last Updated
    October 4, 2012
    Sponsor
    LG Life Sciences
    Collaborators
    BioPartners GmbH
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00596037
    Brief Title
    Treatment of Adults With Growth Hormone Deficiency
    Official Title
    A Phase III, Open-label, Uncontrolled, Multicentre, Rollover Study to Assess Safety and Efficacy of LB03002 Administered Weekly in Adults With Growth Hormone Deficiency
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2006 (undefined)
    Primary Completion Date
    September 2008 (Actual)
    Study Completion Date
    May 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    LG Life Sciences
    Collaborators
    BioPartners GmbH

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pituitary Disorders, Adult Growth Hormone Deficiency
    Keywords
    Growth hormone Deficiency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    136 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    LB03002 throughout
    Arm Type
    Experimental
    Arm Description
    administered LB03002 for preceding 26 weeks
    Arm Title
    Switched to LB03002
    Arm Type
    Experimental
    Arm Description
    administered placebo for preceding 26 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Growth hormone - LB03002
    Primary Outcome Measure Information:
    Title
    Incidence of adverse events, antibody formation and local tolerability assessment after 1 year treatment from baseline of BPLG-005
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    23 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    HJ Ji, PhD
    Organizational Affiliation
    LG Life Sciences
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Treatment of Adults With Growth Hormone Deficiency

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