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Long-acting hGH for Human Growth Hormone Deficiency
Study Summary
This trial is for a long-term, open-label extension using a single patient, multi-dose, disposable pre-filled pen.
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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Who is running the clinical trial?
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- You have diabetes.You have a medical condition or a reason why you cannot receive the r-hGH treatment.You were born smaller than normal for the number of weeks you were in the womb (small for gestational age).You have a history of substance or alcohol abuse.You are allergic to any of the ingredients in the study medication.You do not have any other medical conditions that could cause short stature, such as celiac disease, hypothyroidism, or rickets.You cannot have participated in any other research study with an experimental drug for at least 30 days before screening.
- Group 1: MOD-4023
- 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
Is there an age restriction for participants of this experiment?
"The prerequisites for this experiment necessitates that the participants range between 3 and 11 years of age. There are 13 separate trials available to those aged under 18, and another three for senior citizens."
What is the current size of the population involved with this research?
"The recruitment period for this clinical trial has ended. It was initially posted on February 1, 2013 and updated most recently on April 18, 2022. There are currently 15 trials recruiting participants with human growth hormone deficiency as well as one study that is admitting patients to test MOD-4023."
Can you provide an outline of the other explorations into MOD-4023?
"Presently, only 1 trial is live and administering MOD-4023 with 0 trials in the final Phase 3. While Odessa, Florida houses a portion of these clinical studies, there are an additional 13 sites conducting experiments for this medication."
Is this research pioneering in its methodology?
"Presently, there is one active research trial for MOD-4023 that spans 6 countries and 1 cities. First recorded in 2013, OPKO Health Inc., sponsored the Phase 2 drug approval study which included 48 participants. Since then, 7 additional trials have been conducted."
What risks have been associated with MOD-4023 treatment?
"MOD-4023 is currently in Phase 2, meaning there's evidence of safety but no confirmation that it has the desired effect. Our team at Power assessed its safety to be a 2 on our scale of 1 to 3."
Who is eligible to enroll in this medical experiment?
"To be included in this trial, participants must have human growth hormone deficiency and they must fall within the age range of 3 to 11 years. The maximum number of patients that can join is 48."
Is this test currently open for enrollment?
"Unfortunately, the trial is currently not seeking any additional participants. Initially posted on February 1st 2013 and last updated April 18th 2022, it does not appear to be actively enrolling patients anymore. On the other hand, if you are looking for alternative research studies, 15 trials recruiting those with Human Growth Hormone deficiency as well as a single study searching for MOD-4023 test subjects are available now."
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