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Growth Hormone Therapy for Human Growth Hormone Deficiency (BPLG-004 Trial)
BPLG-004 Trial 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.
BPLG-004 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBPLG-004 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.BPLG-004 Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: LB03002, sustained release human hGH
- 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.
- 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.
Frequently Asked Questions
What has been the general outcome of other research projects involving somatropin?
"There are currently 35 active studies being conducted on the efficacy of growth hormone (somatropin). Of these, 14 have progressed to Phase 3. Interestingly, while a handful of these trials originate from Philadelphia, Pennsylvania, there are 646 total locations running clinical trials for growth hormone (somatropin) around the world."
Are people over the age of 35 welcome in this trial?
"This particular trial is meant for children aged 3-11, with 33 other trials targeting a younger demographic and 14 clinical trials focused on adults over the age of 65."
For what conditions is growth hormone (somatropin) most often prescribed?
"Growth hormone (somatropin) is a medication that has many potential uses, such as treating post-operative patients or those with antiretroviral therapy. It can also help people who suffer from short stature or open epiphyses."
When you say 'individuals,' do you mean patients or doctors?
"Unfortunately, this particular trial is no longer admitting patients. The study was first posted on September 1st, 2005 and the last update to the listing was on March 16th, 2010. However, there are many other trials actively recruiting participants; 15 for human growth hormone deficiency and 35 studies investigating growth hormone (somatropin)."
Is there a risk of serious harm associated with growth hormone (somatropin)?
"Somatropin, commonly known as growth hormone, has received a score of 3 on Power's safety scale. This is due to it being in Phase 3 clinical trials, which means that while there is data supporting its efficacy, there are multiple rounds of data affirming its safety."
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