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PTR-01 for Dystrophic Epidermolysis Bullosa

Phase 2
Waitlist Available
Research Sponsored by Phoenix Tissue Repair, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 246 days
Awards & highlights

Study Summary

This trial will allow some patients to keep taking the drug if it's working for them, to see if it continues to be effective.

Eligible Conditions
  • Dystrophic Epidermolysis Bullosa

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 246 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 246 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of treatment-emergent adverse events
Sustained wound healing
Secondary outcome measures
Change in Investigator Global Impressions of Change (IGIC)
Change in Investigator Patient Impressions of Change (PGIC)
Change in amount of wound care
+31 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: PTR-01Experimental Treatment1 Intervention
All patients will receive a PTR-01 dose of 3.0 mg/kg once weekly every week for a total of 4 doses, followed by a dose of 3.0 mg/kg once monthly for a total of 5 doses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PTR-01
2021
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Phoenix Tissue Repair, a BridgeBio companyUNKNOWN
Phoenix Tissue Repair, Inc.Lead Sponsor
2 Previous Clinical Trials
18 Total Patients Enrolled
Dan Rudin, MDStudy DirectorPhoenix Tissue Repair
1 Previous Clinical Trials
106 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Extension Study to PTR-01-002 (A Study in Recessive Dystrophic Epidermolysis Bullosa (RDEB) Patients Previously Treated With PTR-01)
2021. "Extension Study to PTR-01-002 (A Study in Recessive Dystrophic Epidermolysis Bullosa (RDEB) Patients Previously Treated With PTR-01)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05143190.
~1 spots leftby Apr 2025
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