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Weekly Growth Hormone for Growth Hormone Deficiency in Children
Study Summary
This trial will test if ALTU-238 is a safe and effective treatment for growth hormone deficiency in children who have not yet reached puberty.
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 2017 Phase 4 trial • 82 Patients • NCT02311894Trial Design
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- My thyroid medication dose has been stable for 6 weeks and my thyroid and cortisol levels are normal.I have been diagnosed with growth hormone deficiency based on specific tests.You have had CT or MRI scans of your head after being diagnosed with GHD.I am a boy aged 3-13 or a girl aged 3-12.You have had an autoimmune disease in the past.My growth rate is at or below the average for my age and sex.My growth is significantly below average for my age and sex, or I have a brain condition affecting growth.I have a severe condition affecting my growth, like malnutrition or bone issues.I have or had increased pressure in my brain not caused by a tumor.I haven't taken high doses of steroids by mouth or injection in the last 3 months.I have not participated in another clinical trial or taken any experimental drugs within the last 30 days to 6 weeks.I haven't had brain tumor treatment in the last year.I have had cancer that did not affect my brain.I have not started puberty yet.My growth hormone levels are lower than normal for my age and sex.I have not had a severe illness in the last 6 months.I have taken medications that could affect growth.I have previously been treated with growth hormones or sex steroids.Your liver enzymes (ALT or AST) are higher than 1.5 times the normal level.I have a condition like Turner, Noonan, or Prader-Willi syndrome that affects growth.I have a history of a condition like diabetes or chronic kidney disease that could affect growth.I have active brain cancer confirmed by recent scans.My child's bone age is 11 years or less if they are a boy, and 10 years or less if they are a girl.
- Group 1: 3
- Group 2: 4
- Group 3: 1
- Group 4: 2
- 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 are some of the risks associated with taking Somatropin?
"Somatropin received a safety score of 2. This is due to the lack of data affirming its efficacy, although there are studies that suggest it may be safe for human use."
What are the most popular conditions that Somatropin is used to alleviate?
"Although general surgery is the most common use for Somatropin, this medication can also help patients with short stature, open epiphyses, and antiretroviral therapy."
If a person is younger than 70 years old, can they participate in this research project?
"3-year-old children who have not yet reached their 13th birthday are eligible to enroll in this study."
If a patient were interested in enrolling in this trial, how many different sites would they have to choose from?
"There are 11 sites where this trial is taking place. Some notable locations include Seattle, Little Rock and Worcester. If you choose to participate in this study, it would be advantageous to select the site that is most convenient for you to limit travel."
Are people with the specific illness still being recruited for this trial?
"This particular clinical trial, as indicated on clinicaltrials.gov, is not currently looking for candidates; however, it was last edited on 5/6/2009. There are 89 other trials that are presently recruiting patients."
Are there any restrictions for subjects in this research?
"This trial is for 36 patients between the ages of 3 and 13 who have hypophysial dwarfism. In order to be eligible, participants must also meet the following criteria: Bone age at Screening of ≤ 11 years for boys and ≤ 10 years for girls, Pre-pubertal at Screening (Tanner stage 1 for both breast/genitalia and pubic hair, Pre-treatment annualized height velocity ≤ median (50th percentile) for chronologic age and sex (based on values for delayed maturers provided in Appendix 4), utilizing Screening height and height obtained 52 ± 13 weeks (i.e"
How many individuals are being monitored during this research project?
"This study is no longer recruiting new patients. The study was originally posted on March 1st, 2009 and edited for the last time on May 6th, 2009. However, there are 54 other trials for hypophysial dwarf and 35 trials for Somatropin that are still looking for participants."
Has a trial like this been conducted before?
"Somatropin has undergone 35 different clinical trials since 2005, with the most recent one still underway. Somatropin's first trial involved 144 patients and was sponsored by BioPartners GmbH; it completed Phase 3 in 2005. In total, 209 trials have been completed for this medication as of now."
What other studies have there been with Somatropin?
"Somatropin is being actively researched in 35 different clinical trials, 14 of which are in Phase 3. The largest concentration of these research studies are located in Philadelphia, Pennsylvania; however, there are a total of 646 clinical trial sites for Somatropin across the globe."
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