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Study Summary
This trial is an extension of a previous study to assess the long-term safety and efficacy of Recifercept, a drug used to treat people with a positive risk:benefit profile. Approximately 63 participants will be offered the chance to continue taking the drug for up to 24 months.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Frequently Asked Questions
Has the FDA approved of Recifercept for medicinal use?
"Our internal classification of recifercept's safety sits at 2 because, despite there being some information on its security profile, no studies have been conducted to prove the medication's efficacy."
Does this medical trial cater to individuals aged 55 and over?
"To participate in this trial, individuals must be between 15 months and 12 years of age. Additionally, there are a total of 12 clinical trials for minors and 3 studies aimed at those 65 or above."
What is the current enrollment count for this research study?
"That is correct. According to the clinicaltrials.gov page, this study which was initially posted on December 24th 2021 is currently enrolling participants from 6 different sites with a total goal of 63 patients."
Are there any restrictions on who can partake in this medical investigation?
"To be eligible for this clinical trial, individuals must have achondroplasia and fall between the ages of 15 Months and 12 Years old. A total of 63 applicants will receive admission into the study."
Are there ample sites in this city offering participation in the trial?
"There are 6 clinical trial centres currently recruiting participants for this study, including Nemours Children's Hospital in Wilmington, Long Beach Memorial Medical Center in Long Beach and Ocean Sleep Medicine in Irvine. Additionally, 3 other locations have been identified as potential sites."
What is the overall objective of this investigation?
"This trial's chief efficacy measure, evaluated from baseline to 24 months following the last dose, is the Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs). Additionally, Pharmacokinetics - Apparent Clearance (CL/F), Change from Baseline in Polysomnography, and Change from Baseline in Lower Leg Length will be observed as secondary objectives. The former measurement assesses a drug's rate of metabolic elimination while the latter two respectively consider SaO2 nadir and knee height:lower segment ratio."
Are there any openings for participants in this research?
"Data on clinicaltrials.gov reveals that this experiment is actively recruiting patients, having been posted in late December 2021 and most recently updated at the start of November 2022."
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