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TransCon CNP for Achondroplasia (ApproaCH Trial)
Phase 2 & 3
Waitlist Available
Research Sponsored by Ascendis Pharma Growth Disorders A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
ApproaCH Trial Summary
This trial tests a drug to help with growth in children 2-11 with Achondroplasia. It's a double-blind, placebo-controlled study with an Open Label Extension.
Who is the study for?
This trial is for children aged 2 to 11 with confirmed Achondroplasia who can stand without assistance. They must have a history of growth and disease from previous trials or medical records, and their parents must consent and be able to administer weekly injections. Children with chronic anemia, renal insufficiency, recent participation in other clinical trials, closed epiphysis, hypersensitivity to the drug components, other growth disorders or conditions affecting stature are excluded.Check my eligibility
What is being tested?
The trial tests TransCon CNP's effectiveness on improving annual growth velocity compared to placebo over one year in children with Achondroplasia. It's a double-blind study where neither participants nor researchers know who receives the real treatment until after the results are collected. Afterward, there's an open-label extension for another year.See study design
What are the potential side effects?
While specific side effects aren't listed here, common concerns may include reactions at injection sites such as pain or swelling, potential allergic reactions if sensitive to ingredients in TransCon CNP or placebo components. Other risks could involve how the body reacts overall to new treatments.
ApproaCH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Annualized Growth Velocity
Secondary outcome measures
Height Z-score
ApproaCH Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TransCon CNPExperimental Treatment1 Intervention
Once weekly double-blinded treatment with SC injection of 100 µg/kg of TransCon CNP for 52 weeks
Group II: Placebo for TransCon CNPPlacebo Group1 Intervention
Once weekly double-blinded treatment with SC injection of 100 µg/kg of Placebo for TransCon CNP for 52 weeks
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Who is running the clinical trial?
Ascendis Pharma Growth Disorders A/SLead Sponsor
2 Previous Clinical Trials
212 Total Patients Enrolled
2 Trials studying Achondroplasia
212 Patients Enrolled for Achondroplasia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I need urgent surgery due to severe neck spine compression.I can stand up on my own without help.My guardian can give me weekly shots and follow the study rules.My recent health checks and tests show I am fit for the trial.I have had surgery on my bones that could affect their growth.I have taken medication or had surgery to influence my growth or body shape.I am between 2 and 11 years old.My growth plates have closed.I don't need long-term or frequent steroid treatments during the trial.I have a condition affecting my bone growth, not including ACH.I have a condition causing short stature or abnormal growth.My parent or guardian has signed the consent form for me to participate.I have a clinical diagnosis of ACH with genetic proof.My vitamin D levels are within the acceptable range for the study, or I am willing to start vitamin D supplements if needed.My guardian can give me weekly shots and follow the study rules.I am between 2 and 11 years old.My parent or guardian has signed the consent form for me.I have a confirmed genetic diagnosis of ACH.I can stand up on my own without help.
Research Study Groups:
This trial has the following groups:- Group 1: TransCon CNP
- Group 2: Placebo for TransCon CNP
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could seniors aged 70 and above take part in this trial?
"For this research, individuals who are over the age of two and below eleven years old will be accepted as participants."
Answered by AI
Are additional participants needed for this experiment?
"Affirmative. Clinicaltrials.gov verifies that this research trial, which was first released on March 3rd 2023, is still actively recruiting patients. A total of 80 individuals are needed to be recruited from two distinct medical centres."
Answered by AI
To what extent are participants being included in this experiment?
"Affirmative. Clinicaltrials.gov's records confirm that the recruitment for this research trial is ongoing, having first been posted on March 3rd 2023 and recently updated on March 15th. The study looks to recruit 80 patients from two sites in total."
Answered by AI
Who else is applying?
What site did they apply to?
Ascendis Pharma Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
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