BEGEDINA versus ’Conventional Treatment’ for treating Acute GvHD
Research type
Research Study
Full title
Prospective, phase II/III, randomised clinical study to compare BEGEDINA® versus “conventional treatment” for treating steroid resistant acute graft-versus host disease
IRAS ID
183217
Contact name
Nicola Turvey
Contact email
Sponsor organisation
ADIENNE SA
Eudract number
2015-001360-19
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND Number, 117373
Duration of Study in the UK
2 years, 5 months, 1 days
Research summary
Acute graft versus host disease (GvHD)is a condition that occurs commonly following a bone marrow or stem cell transplant. The transplanted cells (known as “graft cells”) see the recipient’s cells as being “foreign” and try to attack them. Acute GvHD affects the skin, liver, and gastrointestinal (stomach and intestines) tissues, and infrequently the eyes and mouth may also be affected. \nGvHD is usually treated first with a medication known as a steroid. In cases where the GvHD does not respond well to steroid treatment (known as “steroid resistance”), patients are offered further medications (known as “second-line therapies”). However, the medications currently available to patients with steroid-resistant GvHD often do not work well. Survival in this group of participants is poor and new treatment options are urgently needed. Very few studies have evaluated the efficacy and safety of second-line therapy for acute GvHD.\nBEGEDINA (the study drug) has been known to bind to T cells which play a part in the GvHD development. The objectives of this study is to investigate the feasibility, efficacy and safety or BEGEDINA in participants with steroid-resistant acute GvHD. \nThis is a multicentre, randomised (like the tossing of a coin), open label (clinician and participant will know what treatment they have been assigned to) clinical study in which participants will be randomly assigned to receive the study drug or the best conventional treatment. This study will be conducted at approx. 30 bone marrow transplantation units in Europe, US and Canada. It is planned to enrol approximately 184 participants. \n\n
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0771
Date of REC Opinion
23 Nov 2015
REC opinion
Further Information Favourable Opinion