Pura-HHT RCT: Evaluating PuraBond® for mild-moderate Epistaxis in HHT
Research type
Research Study
Full title
Pura-HHT trial: A Double-blind Randomised Placebo-controlled trial with a crossover design to evaluate the efficacy of intranasal application of a Self-Assembling Peptide (SAP) RADA16, available commercially as PuraBond®, for mild-moderate epistaxis in Patients with Hereditary Hemorrhagic Telangiectasia (HHT)
IRAS ID
351257
Contact name
Sarah Pountain
Contact email
Sponsor organisation
University Hospitals Birmingham NHS Foundation Trust
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
Hereditary Haemorrhagic Telangiectasia(HHT) is a rare genetic blood vessel disorder that affects approximately 1 in every 5,000 to 10,000 people globally.This condition causes abnormal blood vessel formations such as telangiectasias or small dilated vessels and arteriovenous malformations or abnormal connections between arteries and veins,which can cause bleeding into the lungs,liver,gut,and the brain.One of the most common and distressing symptoms of HHT is sudden,frequent nosebleeds that severely affect daily quality of life and can lead to life-threatening complications.Although there is currently no cure for HHT, treatments aim to minimise the frequency and severity of these nosebleeds.Recent research has highlighted the potential of PuraBond:a self-assembling peptide made up of four amino acid repeats,which promotes instant gelation to stop bleeding during surgeries and aids in healing.Unlike traditional treatments, PuraBond does not swell or need mixing, is biodegradable,and comes in ready-to-use syringes,making it a promising solution for managing nosebleeds.
The Pura-HHT trial will assess the efficacy of PuraBond in reducing the severity of nosebleeds,measured by the Epistaxis Severity Score(ESS),in comparison to a placebo (KY jelly).This study will utilise a double-blind,randomised,placebo-controlled design involving 12 patients over two six-week treatment phases(P1 P2),with a four-week washout period between them.Participants will visit the hospital each week, where the two products PuraBond and KY jelly in identical syringes labelled X and Y will be administered,e.g X in the right nostril and Y in the left for 6 weeks(P1). After a four-week break with no treatment or visits, the treatments will be swapped between the nostrils for another 6 weeks(P2) followed by a 4week maintenance phase with no treatments or visits.
People with HHT have helped design this study to ensure it addresses patient needs.The findings could reduce nose bleed severity improving the quality of life, reduce hospital visits, easing pressure on NHS services.Results will be shared through scientific journals and conferences.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
26/LO/0271
Date of REC Opinion
28 May 2026
REC opinion
Further Information Favourable Opinion