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Weekly vs Daily Growth Hormone for Growth Hormone Deficiency
Study Summary
This trial is conducted to study the effectiveness and safety of a once-weekly hormone treatment compared to the daily growth hormone treatment in growth hormone naïve children before puberty. The trial has several phases and will follow participants for a long period of time.
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.Side effects data
From 2018 Phase 3 trial • 62 Patients • NCT03075644Trial Design
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- Boys must be between 2.5 and 10 years old and show early signs of puberty. Girls must be between 2.5 and 9 years old and also show early signs of puberty. They must have been diagnosed with growth hormone deficiency within the last 12 months, be shorter than most kids their age, and have a slow growth rate. They should not have received growth hormone or IGF-I treatment before.I am younger than 2 years and 6 months and weigh at least 5 kg.I have been diagnosed with growth hormone deficiency in the last year.I have never been treated with GH or IGF-I therapies.I am a child with growth hormone deficiency and have open growth plates.I am a boy under 10 years old with early puberty signs.I am a girl aged 2.5 to 9 years, with early puberty signs.My growth rate is slower than expected for my age and gender.I have a condition or history that could affect my growth measurements.I am under 2.5 years old, weigh at least 5 kg, have GHD without prior GH or IGF-I treatment, and my IGF-1 SDS is below -1.0.My growth hormone deficiency (GHD) has been confirmed by a doctor.My growth hormone levels are low, as shown by an IGF-1 SDS score below -1.0.I have never been treated with growth hormone or IGF-I.I am significantly shorter than average for my age and gender.
- Group 1: Blinded NNC0195-0092 (somapacitan) (0.08 mg/kg/week)
- Group 2: Open labelled daily Norditropin® (0.034 mg/kg/day)
- Group 3: Blinded NNC0195-0092 (somapacitan) (0.04 mg/kg/week)
- Group 4: Blinded NNC0195-0092 (somapacitan) (0.16 mg/kg/week)
- 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
Would somapacitan be considered a high-risk medication?
"Somapacitan has undergone some testing for safety, but not yet for efficacy. It received a score of 2."
Could I join the ranks of this clinical trial's participants?
"In order to be eligible for this research, participants must have growth hormone excess and be between 30 months and 10 years old. Up to 74 individuals will be accepted into the clinical trial."
To what extent is this clinical trial populated?
"That is correct, the online information portal clinicaltrials.gov has listed this trial as currently looking for participants. This particular study was posted on March 23rd, 2016 with the most recent update happening on November 8th, 2022. They are hoping to enroll 74 individuals from 5 different medical sites."
In how many places is this trial being conducted?
"This study is looking for willing participants from 5 different enrolment sites, which are located in New Brunswick, Cincinnati and Wilmington. There are also other locations in 5 additional cities. If you enroll in this trial, be sure to choose the location nearest to you so that travel isn't too demanding."
Has this research been conducted before?
"Somapacitan has a long clinical history, with the first trials occurring in 2005. After an initial Phase 3 study involving 144 people, somapacitan was approved for general use. Currently, there are 35 open trials being conducted in 170 different cities and 45 countries around the world."
What other research studies have included somapacitan as a variable?
"The first study involving somapacitan was completed in 2005 by the Children's Hospital of Philadelphia's Division of Endocrinology. Since then, a total of 214 clinical trials have used this medication. As of now, there are 35 live trials being conducted; many of these studies are based out of New Brunswick, New jersey."
By what metric will the success of this research be measured?
"The primary outcome of this clinical trial, which will be assessed over a time frame of 208 weeks, is Cohort I's height velocity (HV) during the first 26 weeks of treatment. Secondary outcomes include changes in emotional well-being score, physical health score, social well-being score and total score in Treatment Related Impact Measure - Child Growth Hormone Deficiency- Observer (TRIM-CGHD-O), as well as serum NNC0195-0092 (somapacitan) concentrations."
Is this research project still recruiting participants?
"Currently, this study is looking for volunteers as noted on clinicaltrials.gov. The listing was first created on March 23rd, 2016 and the most recent update was November 8th, 2022."
Does this clinical trial have an age limit?
"The age limit for this clinical trial are participants who are over 30 months old, but younger than 10 years of age."
Why is somapacitan generally prescribed to patients?
"Somapacitan has shown to be an effective medical intervention for general surgery, short stature, and open epiphyses."
Who else is applying?
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