CompletedPhase 2

Extension Study to PTR-01-002 (A Study in Recessive Dystrophic Epidermolysis Bullosa (RDEB) Patients Previously Treated With PTR-01)

United States2 participantsStarted 2021-12-02

Plain-language summary

A sub-set of patients who participated in PTR-01-002 will be enrolled in an open-label study, if they meet the study eligibility criteria.

Age range12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Willing to provide informed consent form, or if 12 to \<18 years of age, legal guardian has provided informed consent form and the minor has signed an assent form acknowledging that they understand and agree to study procedures.
✓. Has satisfactorily completed participation in PTR-01-002.
✓. Agrees to use contraception as follows:
✓. Be willing and able to comply with this protocol.

✕. Has known systemic hypersensitivity to any of the inactive ingredients in PTR-01.
✕. Has previously had an anaphylactic reaction to PTR-01.
✕. Is pregnant or nursing.
✕. Has received in the last six months any investigational gene therapy product or in the last three months any non-gene therapy investigational products (other than PTR-01).
✕. Is anticipated to receive new regimens of antibiotics or other anti-infectives during the trial.
✕. Has any other medical or personal condition that, in the opinion of the Investigator, may potentially compromise the safety or compliance of the

Sustained wound healing

Timeframe: Up to 246 days

Incidence of treatment-emergent adverse events

Timeframe: Up to 246 days

NCT IDNCT05143190

SponsorPhoenix Tissue Repair, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-06-20