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Lonapegsomatropin vs Somatropin for Turner Syndrome
Study Summary
This trial tests a long-acting growth hormone product given once/wk vs daily injections in kids with Turner Syndrome in the US. 48 kids (12/arm) will be randomized.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am not taking any drugs that affect growth hormone actions.Showing slow or abnormal growth based on at least one of the following:I have been diagnosed with diabetes.I have a history of cancer.I have been on stable hormone replacement therapy, except for growth hormone, for over 4 weeks.My child's height velocity is less than 6 cm/year or below the 25th percentile for their age.I am pregnant, planning to become pregnant, or am breastfeeding.I have Turner Syndrome with Y-chromosome material and no history of gonad removal.My thyroid function is normal, with or without medication.My eye exam showed no signs of high brain pressure or serious retina problems.I haven't had major surgery, serious injuries, or severe illness in the last 6 months.I have conditions like celiac or ADHD that could affect my growth.My high blood pressure is not well-managed.I have never been treated with growth hormone or growth hormone secretagogues.You have a heart problem that could affect your growth, as shown by a special heart ultrasound test.I have not taken any corticosteroids by mouth, IV, or muscle injection in the last 90 days.I have been diagnosed with TS through a genetic test.I have not yet gone through puberty.I can sign the consent form myself, or my guardian can.I am between 1 and 10 years old.My bone age matches my actual age, within a 20% range.I have had a brain tumor or cyst that has grown in the last year.Your liver enzymes (AST or ALT) are more than 3 times the normal level.I do not have major health issues or reasons I can't take human growth hormone.My kidney function is not normal.My height is below the 10th percentile for my age and sex.
- Group 1: Lonapegsomatropin at 0.24 mg hGH/kg/week
- Group 2: Lonapegsomatropin at 0.30 mg hGH/kg/week
- Group 3: Lonapegsomatropin at 0.36 mg hGH/kg/week
- Group 4: Somatropin at 0.05 mg/kg/day
- 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 the trial open to minors?
"This research project is looking for participants that are younger than 10 years of age and older than a year."
How many established healthcare facilities are conducting this research?
"Currently, 17 research sites are participating in this clinical trial. These locations stretch across the country from Palo Alto to Aurora and San Diego as well as 14 other cities. To minimize travel requirements, it is best to choose a site nearest you if you decide to join the study."
Is Lonapegsomatropin dosage of 0.24 mg hGH/kg/week safe for patients?
"Currently, Lonapegsomatropin administered in doses of 0.24 mg hGH/kg/week is evaluated to be relatively safe with a score of 2 due to Phase 2 trial data indicating some evidence for safety but no efficacy results yet."
Does this trial have vacancies for participants at present?
"Clinicaltrials.gov reports that this medical study, which initial posting was on January 1st 2023, is not actively enrolling participants at the moment. However, there are 1369 other clinical trials currently in progress and open to patient recruitment."
Could I register to participate in this clinical trial?
"This clinical trial is seeking 48 prepubertal children who have been diagnosed with Turner Syndrome and are between 1 - 10 years of age. Additional criteria must be met by participants, including having a height lower than the 10th percentile for sex/age according to 2000 CDC Growth Charts for America, bone age at no more than their chronological age on left wrist radiograph scans during screening, biochemically euthyroid without signs or symptoms of intracranial hypertension or proliferative retinopathy in fundoscopy screenings, and stable doses of hormone replacement therapies (other than growth hormones) taken four weeks prior to Screening onwards."
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