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Long-acting hGH (MOD-4023) for Growth Hormone Deficiency
Study Summary
This trial will compare the effectiveness and safety of a new weekly growth hormone therapy to the current daily therapy.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 3 trial • 44 Patients • NCT03874013Trial Design
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- I completed the main study and followed the treatment plan well.My health has not worsened due to serious illness or severe medication reactions during treatment.I am committed to following the study's requirements.You are pregnant.My child is between 3 and 11/12 years old and has a growth hormone deficiency.My bone age matches my actual age and is under 10 for girls or under 11 for boys.I have never been treated with r-hGH.My growth rate is slower than expected for my age and gender.My child had leukemia, lymphoma, sarcoma, or another cancer before.My child is underweight for their age and sex.You have antibodies against human growth hormone.I am a diabetic patient not following or responding well to my current treatment.I have had radiation therapy or chemotherapy in the past.My IGF-1 levels are lower than normal for my age and sex.I have a genetic condition like Turner's or Noonan syndrome.My child takes more than 400 μg/d of inhaled steroids for asthma.My growth plates have closed.My short stature is not due to celiac disease, untreated thyroid issues, or rickets.I am HIV-positive or have advanced diseases like AIDS or tuberculosis.I do not abuse drugs, substances, or alcohol.My kidney function, measured by GFR, is normal for my age.I am not taking any growth-affecting drugs except for ADHD medication or hormone replacements.My child was born smaller than expected for their gestational age.My child has been diagnosed with psychosocial dwarfism.I have no ongoing serious side effects from Genotropin or MOD-4023.My genetic test shows I have a normal female chromosome pattern.My child has been on stable hormone replacement therapy for other conditions for at least 3 months.I don't have any health issues that could affect my growth.I do not have major health issues or reasons I can't take growth hormone treatment.You have been diagnosed with growth hormone deficiency confirmed by two different tests showing low levels of growth hormone in your blood.
- Group 1: MOD-4023
- Group 2: Genotropin
- 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Are there harmful side effects associated with MOD-4023?
"MOD-4023 is in Phase 3 of clinical trials, meaning that there is evidence of efficacy as well as support from multiple rounds of safety data. Consequently, our team has rated the safety a 3."
What are the primary reasons that MOD-4023 is prescribed?
"MOD-4023 is frequently used to treat patients with general surgery. This medication is also effective at treating short stature, open epiphyses, and antiretroviral therapy."
With how many different organizations is this research being conducted?
"In addition to Albert Einstein College of Medicine at Yeshiva University in Mineola, New york, Goryeb Children's Hospital in Morristown, New jersey, and Mary Bridge Children's Hospital & Health Center in Tacoma, Washington; this clinical trial is also running out of 19 other locations."
Does this research project allow elderly patients to enroll?
"To be eligible for this trial, children must aged between 3 and 11 years old."
Does this research represent a new method for testing treatments?
"Since 2005, MOD-4023 has been the focus of various medical studies. The first study was sponsored by BioPartners GmbH and took place in 144 cities across 45 countries. After this initial research project, Phase 3 drug approval was granted in 2005. As of now, there are 36 active studies being conducted to explore different aspects of MOD-4023's impact."
Are there any other ongoing trials exploring the potential benefits of MOD-4023?
"The first study for MOD-4023 was completed in 2005 by the Children's Hospital of Philadelphia. As of now, there are a total of 212 studies with 36 live clinical trials. The majority of these active trials are based in Mineola, New york."
Are there currently any open spots for participants in this trial?
"Unfortunately, this particular study is not recruiting any more participants. However, there are 21 other clinical trials searching for patients with childhood-onset growth hormone deficiency and 36 different trials for MOD-4023 that might be a match."
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