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REFLECT (symptom-RElieF with Losartan – EB Clinical Trial): A dual-center prospective phase II trial to establish safety, tolerability and efficacy of losartan in children with recessive dystrophic EB

Ongoing
Project lead Prof Leena Bruckner-Tuderman
Organisation University of Freiburg Medical Center
Project budget EUR 498,670.00 + time only extension 18 months
Start date / Duration 01. Mar 2016 / 68 months
Funder(s) / Co-Funder(s) DEBRA Austria, MSAP/EBEP Recommended
Research area Symptom prevention & relief

Project details

Short lay summary

Recessive dystrophic EB (RDEB), caused by collagen VII deficiency, is a chronic, disabling disorder with urgent need for efficacious treatments. In order to find relief and to ameliorate symptoms, we have designed a clinical trial with losartan to limit scarring in people with RDEB. Losartan is a drug that is given orally and has already been approved by the regulatory authorities for the treatment of another disease, namely high blood pressure. It has been used world-wide to treat thousands of people (adults and children) and been found safe. - An important and interesting point for people with RDEB is a second effect of losartan: it can prevent excessive scarring and fibrosis in mouse models.

What did this project achieve?

In June 2017 we initiated the REFLECT-trial in Freiburg (A dual-center prospective phase II trial to establish safety, tolerability and efficacy of losartan in children with recessive dystrophic EB). The goal is to include 30 participants in the trial. In Freiburg we have already enrolled 25 patients. The patient visits were well-planned in advance and the trial runs well and without adverse effects or problems.
To ensure good communication and to discuss first results, we had two trial meetings in Freiburg with participants from the Dept. of Dermatology, the Dept. of Pediatric Cardiology and the Clinical Trial Unit (trial coordinator, monitors, trial assistant ect).
Altogether, in Freiburg we have already enrolled 25 patients in the trial, 15 patients being initially planned for our Center. So far, no concerns on safety and tolerability of the drug were raised by several monitoring visits and a meeting of the Data and Safety Monitoring Committee (DSMC), which held in December 2018 with scientists that do not participate in the trial. So far, losartan seems to be tolerable and safe for the trial population. The data of the first 12 patients, who have completed the trial, seem promising regarding efficacy of the drug.
We experience an unforeseen delay with the second trial Center in Salzburg, Austria. Signing of the contract between our Centers has been handled very slowly by the Legal Department of Salzburg. To date, the contract has not been signed and we have not been able to initiate the trial there. We have informed DEBRA International about this problem. To overcome this issue, we will continue recruiting in Freiburg, until all 30 patients are included in the trial.


Keywords

Bruckner-Tuderman
Freiburg
Losartan
RDEB
clinical trial
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