PASS Safety Study for Delamanid in Routine Medical Practise for MDRTB
Research type
Research Study
Full title
A Multicentre, EU-wide, Non-Interventional Post-Authorisation Study to Assess the Safety and Usage of Delamanid in Routine Medical Practice in Multidrug-Resistant Tuberculosis Patients
IRAS ID
159954
Contact name
Barbara Eschenbach
Contact email
Sponsor organisation
Otsuka Novel Products GmbH
Clinicaltrials.gov Identifier
ENCEPP/SDPP/10618, EU PAS register number
Duration of Study in the UK
6 years, 5 months, 1 days
Research summary
Summary of Research
The purpose of this study is to test the safety and usage of Delamanid prescribed to male and female patients with multidrug-resistant tuberculosis in routine medical practise. This non-interventional, EU-wide, multicentre, post authorisation study is part of the Risk Management Plan by the EMA and will capture data on treatment and management of patients prescribed Delamanid. The total duration of the study per patient is up to 30 months (24 weeks Delamanid with an appropriate combination regimen (ACR), and up to 24 months follow-up with ACR only). The total duration of the whole study is planned to be 6.5 years (4 years enrolment). An apropriate combination regimen will be designed by the treating physician. According to the summary of product characteristics, Delamanid is indicated for use as part of an appropriate combination regimen, when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. The decision to prescribe Delamanid to a patient as part of MDR TB treatment is taken by the physician prior to study entry,
as part of routine care.
Treatment will be performed according to the existing practises and/ treatment centre's national tuberculosis program. By the nature of this study the source of the data collected will be patient records or documentation used for the national tuberculosis program, depending on local circumstances. The study is sponsored by Otsuka Novel Products GmbH (ONPG).Summary of Results
Otsuka have decided not to submit a Lay summary.REC name
London - Queen Square Research Ethics Committee
REC reference
16/LO/1565
Date of REC Opinion
19 Oct 2016
REC opinion
Further Information Favourable Opinion