Biotest NIS real-world use of Cytotect after lung and heart transplant
Research type
Research Study
Full title
International documentation on the use of Cytotect CP® Biotest for patients after lung and heart transplantation
IRAS ID
316652
Contact name
Jasvir Parmar
Contact email
Sponsor organisation
Biotest AG
Duration of Study in the UK
4 years, 0 months, 3 days
Research summary
The Biotest NIS-021 study will evaluate patients with a lung or heart transplantation and who are receiving routine treatment with the medication Cytotect to prevent or treat cytomegalovirus (CMV) infection. The study will collect data about patients disease state and any side effects of the medication.
Cytomegalovirus (CMV) is a virus from the herpesvirus family (the virus that causes chicken pox and herpes simplex). Transmission can occur through body fluids, organ transplantation or during childbirth. When a primary CMV infections occurs, the body will begin to fight the infection by producing antibodies and immune cells.
After infection, the strain remains in an inactive state, however a secondary infection can occur by a reactivation of the latent virus or by super-infection with another strain. An intact immune system is usually capable of coping with a CMV infection, but CMV infection can be a fatal disease in people with immuno-suppression such as organ transplant recipients. CMV can be asymptomatic or can present with flulike symptoms
Anti-rejection medication is taken after organ transplantation to prevent rejection but this medication also inhibits part of the immune system which makes transplant patients more prone to infections and viruses. CMV can be caused be a reactivation of a strain acquired before transplantation or from receiving a CMV-positive donor organ
The study aims to collect data, which is so called “real world data” – this provides information about what is happening in routine medical treatment, rather than inside a controlled clinical trial.
The study does not require any additional visits to the hospital, or any additional tests beyond those, which would be the standard treatment for the patient, at their hospital. This kind of study is called a “non-interventional” study.
The doctors treating the patients will collect the “real-world” data over a period of 2 years for each patient. The data will be analysed by the pharmaceutical company in order to better understand how the medicine is working.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
22/NE/0165
Date of REC Opinion
8 Aug 2022
REC opinion
Favourable Opinion