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Growth Hormone
Growth Hormone Therapy for Human Growth Hormone Deficiency (BPLG-004 Trial)
Phase 3
Waitlist Available
Research Sponsored by LG Life Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Height of at least 2.0 SD below the mean height for chronological age and sex
Confirmed diagnosis of GH insufficiency as determined by two different GH provocation tests with peak plasma GH level of ≤7 ng/ml
Must not have
Children requiring glucocorticoid therapy exceeding specified dose and duration
Closed epiphyses
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial will compare the effectiveness of a new, once-weekly growth hormone treatment with the current standard of daily growth hormone injections in children with insufficient growth hormone production.
Who is the study for?
This trial is for pre-pubertal children with growth hormone deficiency who haven't had growth hormone treatment before. They should be significantly shorter than average for their age and sex, have a confirmed diagnosis of GH insufficiency, and no major health issues that could affect growth. Children treated for brain tumors must be in remission.
What is being tested?
The study compares a new weekly growth hormone injection to the standard daily treatment in children with insufficient secretion of growth hormone. The goal is to see if the new method works as well or better than the daily shots.
What are the potential side effects?
Growth hormone treatments can cause side effects like pain at the injection site, headaches, joint stiffness, muscle pain, and flu-like symptoms. Some kids might also experience swelling or numbness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am significantly shorter than average for my age and sex.
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I have been diagnosed with growth hormone deficiency.
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I have never been treated with rhGH.
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My child has a growth hormone deficiency.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My child needs more than the usual dose of steroids for a long time.
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My growth plates have closed.
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My pituitary gland disorders are not well-managed.
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I do not have major health issues or reasons I can't take growth hormone treatment.
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I am HIV-positive or have advanced diseases.
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My cancer is growing or spreading.
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I have diabetes or high blood sugar when fasting.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
1Treatment groups
Experimental Treatment
Group I: LB03002, sustained release human hGHExperimental Treatment1 Intervention
LB03002
Find a Location
Who is running the clinical trial?
LG Life SciencesLead Sponsor
85 Previous Clinical Trials
21,052 Total Patients Enrolled
3 Trials studying Human Growth Hormone Deficiency
299 Patients Enrolled for Human Growth Hormone Deficiency
BioPartners GmbHIndustry Sponsor
5 Previous Clinical Trials
370 Total Patients Enrolled
1 Trials studying Human Growth Hormone Deficiency
51 Patients Enrolled for Human Growth Hormone Deficiency
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking growth-promoting drugs like anabolic steroids.My child needs more than the usual dose of steroids for a long time.I am significantly shorter than average for my age and sex.I do not have any genetic disorders, except possibly septo-optic dysplasia.I have been diagnosed with growth hormone deficiency.My growth hormone deficiency started after brain tumor treatment, and I've been in remission for a year.My child's brain scan in the last year showed no tumor growth.I have never been treated with rhGH.My IGF-I level is lower than average for my age and sex.My growth plates have closed.My pituitary gland disorders are not well-managed.I am HIV-positive or have advanced diseases.I do not have major health issues or reasons I can't take growth hormone treatment.My cancer is growing or spreading.My child has a growth hormone deficiency.I have diabetes or high blood sugar when fasting.
Research Study Groups:
This trial has the following groups:- Group 1: LB03002, sustained release human hGH
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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