MedTrace Logo

A Long-term Treatment With B-VEC for Dystrophic Epidermolysis Bullosa

NCT04917874 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2024-04-09

No results posted yet for this study

Summary

This is a 112-week (approximately two-year) open-label extension study of Beremagene Geperpavec (B-VEC), for participants aged 2 months and older, who have been diagnosed with Dystrophic Epidermolysis Bullosa (DEB). Participants will be dosed weekly with the topical B-VEC therapy. The primary endpoint will be to assess long term safety and tolerability of the topical gene therapy. The study is for those who participated in Phase 3 study, as well as, new participants who were unable to participate in the Phase 3 study, who meet all enrollment criteria.

Conditions

Interventions

BIOLOGICAL

Open Label Topical Beremagene Geperpavec (B-VEC)

Topical gel of non-integrating, replication-incompetent HSV-1 expressing the human collagen VII protein

Sponsors & Collaborators

  • Krystal Biotech, Inc.

    lead INDUSTRY

Principal Investigators

  • David Chien, MD · Senior Vice President of Clinical Development

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-25
Primary Completion
2023-07-31
Completion
2023-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04917874 on ClinicalTrials.gov