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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 28 days after last detection of rtx-134
Awards & highlights
Study Summary
This trial will test a new drug, RTX-134, to see if it is safe and tolerated by adults with PKU.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 28 days after last detection of rtx-134
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 28 days after last detection of rtx-134
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To correlate dose with percent reduction in serum phenylalanine levels relative to baseline
To determine a preliminary dose to achieve serum phenylalanine levels < 360 µmol/L
To determine a preliminary dose to achieve serum phenylalanine levels < 600 µmol/L
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: RTX-134Experimental Treatment1 Intervention
Escalating doses of RTX-134 will be administered by intravenous infusion one time
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Who is running the clinical trial?
Rubius TherapeuticsLead Sponsor
3 Previous Clinical Trials
85 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any unfilled spots still available in this trial?
"The information accessible on clinicaltrials.gov indicates that, despite being initially posted in January 2020 and edited as recently as October 2022, this trial is not presently recruiting participants. However, 19 other trials are actively enrolling right now."
Answered by AI
What are the demonstrated safety profiles of RTX-134?
"RTX-134, of which there is limited evidence regarding safety and efficacy, received a score of 1 on our scale for determining its perceived risk level."
Answered by AI
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