A Study of PTR-01 in Recessive Dystrophic Epidermolysis Bullosa
NCT04599881 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2021-09-16
Summary
Protocol PTR-01-002 is a 3-part Phase 2, open-label study of PTR-01. While new patients will be enrolled, priority will be given to patients that satisfactorily completed study PTR-01-001.
Conditions
Interventions
- DRUG
-
PTR-01
IV recombinant collagen 7 at 3 mg/kg given weekly for 4 doses, followed by bi-weekly for 7 doses
Sponsors & Collaborators
-
Phoenix Tissue Repair, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-15
- Primary Completion
- 2021-08-28
- Completion
- 2021-09-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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