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Growth Hormone

Weekly Growth Hormone for Growth Hormone Deficiency in Children

Phase 2
Waitlist Available
Research Sponsored by Altus Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

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.

Who is the study for?
This trial is for prepubertal children with growth hormone deficiency, aged 3-13 years for boys and 3-12 years for girls. They must have a low annualized height velocity and be diagnosed with GHD by specific tests. Children who've had prior growth hormone treatments or suffer from certain diseases like diabetes, genetic syndromes affecting growth, or severe liver/kidney disease cannot participate.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of ALTU-238 as a weekly treatment compared to daily Nutropin AQ in children who naturally produce insufficient growth hormone. It aims to determine if ALTU-238 can effectively treat their condition with less frequent dosing.See study design
What are the potential side effects?
Possible side effects of somatropin (the active ingredient in both ALTU-238 and Nutropin AQ) include injection site reactions, headaches, muscle pain, weakness, insulin resistance and could potentially contribute to hip problems in some cases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.
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I have not started puberty yet.
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I have been diagnosed with growth hormone deficiency based on specific tests.
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I am a boy aged 3-13 or a girl aged 3-12.
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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.
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I am in the earliest stage of puberty according to Tanner stage 1.
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My growth is significantly below average for my age and sex, or I have a brain condition affecting growth.
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My growth rate is at or below the average for my age and sex.
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My growth hormone levels are lower than normal for my age and sex.
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My thyroid medication dose has been stable for 6 weeks and my thyroid and cortisol levels are normal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change in annualized height velocity from pre-treatment to the first 26 weeks of treatment

Side effects data

From 2017 Phase 4 trial • 82 Patients • NCT02311894
21%
Headache
15%
Vomiting
10%
Upper respiratory tract infection
9%
Injection site bruising
7%
Pharyngitis streptococcal
7%
Rash
6%
Pyrexia
6%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Somatropin

Awards & Highlights

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.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: 3Experimental Treatment1 Intervention
ALTU-238
Group II: 2Experimental Treatment1 Intervention
ALTU-238
Group III: 1Experimental Treatment1 Intervention
ALTU-238
Group IV: 4Active Control1 Intervention
Nutropin AQ
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Somatotropin
FDA approved

Find a Location

Who is running the clinical trial?

Altus PharmaceuticalsLead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled

Media Library

Somatropin (Growth Hormone) Clinical Trial Eligibility Overview. Trial Name: NCT00837863 — Phase 2
Human Growth Hormone Deficiency Research Study Groups: 3, 4, 1, 2
Human Growth Hormone Deficiency Clinical Trial 2023: Somatropin Highlights & Side Effects. Trial Name: NCT00837863 — Phase 2
Somatropin (Growth Hormone) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00837863 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

How old are they?
< 18
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
New York
What site did they apply to?
Schneider Children's Hospital
~2 spots leftby Feb 2025