Ph 3 Efficacy and Safety of B-VEC for the Treatment of DEB (NCT04491604) | Clinical Trial Compass
CompletedPhase 3
Ph 3 Efficacy and Safety of B-VEC for the Treatment of DEB
United States31 participantsStarted 2020-08-17
Plain-language summary
To determine whether administration of topical B-VEC improves wound healing as compared to placebo, and to evaluate durability, repeat dosing (Primary Endpoint) and further obtain safety and tolerability data.
Who can participate
Age range
6 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The subject or legally appointed and authorized representative must have read, understood and signed an Institutional Review Board/Ethics Committee (IRB/EC) approved Informed Consent or Assent Form and must be able to and willing to follow study procedures and instructions.
. Age ≥ 6 months and older at the time of Informed Consent.
. Clinical diagnosis of the Dystrophic Epidermolysis Bullosa.
. Confirmation of DEB diagnosis (either DDEB or RDEB) by genetic testing including COL7A1.
. Two (2) cutaneous wounds meeting the following criteria:
. Location: similar in size, located in similar anatomical regions, and have similar appearance
. Appearance: clean with adequate granulation tissue, excellent vascularization, and do not appear infected.
. Subjects and caregivers who, in the opinion of the Investigator, are able to understand the study, co-operate with the study procedures and are willing to return to the clinic for all the required follow-up visits.
Exclusion criteria
. Medical instability limiting ability to travel to the Investigative Center.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary Wound With Complete Wound Healing (100% Wound Closure) on Weeks 22 and 24 or Weeks 24 and 26
. Diseases or conditions that could interfere with the assessment of safety and efficacy of the study treatment and compliance of the subject with study visits/procedures, as determined by the Investigator.
. Current evidence or a history of squamous cell carcinoma in the area that will undergo treatment.
. Subjects actively receiving chemotherapy or immunotherapy at Visit 1 (Week 1).
. Active drug or alcohol addiction as determined by the Investigator.
. Hypersensitivity to local anesthesia (lidocaine/prilocaine cream).
. Participation in an interventional clinical trial within the past three (3) months (not including BVEC administration).
. Receipt of a skin graft in the past three (3) months.