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C-type natriuretic peptide analog

Vosoritide for Turner Syndrome

Phase 2

Recruiting

Research Sponsored by Roopa Kanakatti Shankar, MBBS, MS

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 12 months

Awards & highlights

Study Summary

This trial will study the safety and effectiveness of vosoritide, a CNP analog, to increase growth in pre-pubescent girls with Turner Syndrome, a condition caused by a missing or incomplete second sex chromosome.

Who is the study for?

This trial is for pre-pubertal girls under 11 years old with Turner Syndrome, either not treated with growth hormone or who had a poor response to it. They must be willing to follow study procedures and have a height significantly below average for their age. Girls with fused growth plates, Y-chromosome material without gonadectomy, significant unrelated health issues, allergies to the medication, or recent investigational drug use are excluded.Check my eligibility

What is being tested?

The trial tests Vosoritide's effectiveness in increasing growth velocity over 12 months in girls with Turner Syndrome who have short stature. It compares their growth rate on Vosoritide against historical data from before treatment. Responders can continue receiving the drug after the initial study period.See study design

What are the potential side effects?

While specific side effects of Vosoritide aren't listed here, similar treatments may cause reactions at injection sites, headaches, nausea, and potential long-term effects on bone development. Safety monitoring during the trial will track any adverse events.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in age-sex standardized height standard deviation score

Change from baseline in annualized growth velocity

Incidence of treatment-emergent adverse events

Secondary outcome measures

Change in Bone Age

Changes in arm span minus standing height

Changes in seated height ratio

Trial Design

1Treatment groups

Experimental Treatment

Group I: Vosoritide treatment armExperimental Treatment1 Intervention

Vosoritide will be administered daily via subcutaneous injection for 12 months using the FDA approved weight-based dosing band strategy for achondroplasia.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Roopa Kanakatti Shankar, MBBS, MSLead Sponsor

Roopa Kanakatti ShankarLead Sponsor

Media Library

Vosoritide (C-type natriuretic peptide analog) Clinical Trial Eligibility Overview. Trial Name: NCT05849389 — Phase 2

Turner Syndrome Research Study Groups: Vosoritide treatment arm

Turner Syndrome Clinical Trial 2023: Vosoritide Highlights & Side Effects. Trial Name: NCT05849389 — Phase 2

Vosoritide (C-type natriuretic peptide analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05849389 — Phase 2

Frequently Asked Questions

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

Could I potentially qualify for participation in this experiment?

"Eligible participants must have been diagnosed with Turner Syndrome and fall within the range of 3 to 11 years old. This medical trial is seeking approximately 20 volunteers."

Answered by AI

Does the trial accept geriatric patients?

"This medical research calls for participants aged between 3 and 11 years old. As a point of reference, there are 400 trials recruiting individuals under 18 and 1004 trials in search of volunteers over 65."

Answered by AI

Are there any risks to individuals who opt for Vosoritide treatment?

"The safety of the Vosoritide treatment arm was evaluated as a 2 on our team's 1-3 scale due to limited data concerning efficacy, but sufficient evidence supporting its general safety."

Answered by AI

Are individuals being enrolled in this research endeavor presently?

"Based on the information found online, this medical trial is no longer open to recruitment. Originally posted in September 1st 2023 and last updated April 28th of that same year, it seems as though 1453 other clinical trials are available for prospective participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vosoritide for Short Stature in Turner Syndrome

Roopa Kanakatti Shankar, MBBS, MS 2024. "Vosoritide for Short Stature in Turner Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05849389.

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