WEUSKOP7134: A prospective, observational cohort study nested within the HCV Research UK National Registry to evaluate real-world use of eltrombopag in adult patients with chronic Hepatitis C Virus infection who are unable to initiate or maintain optimal interferon-based therapy due to thrombocytopenia (201109)

Study identification

• EU PAS number:
  EUPAS7305
• Study ID:
  17398
• Official title and acronym:
  WEUSKOP7134: A prospective, observational cohort study nested within the HCV Research UK National Registry to evaluate real-world use of eltrombopag in adult patients with chronic Hepatitis C Virus infection who are unable to initiate or maintain optimal interferon-based therapy due to thrombocytopenia (201109)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Eltrombopag is a 2nd generation oral thrombopoeitin receptor agonist developed by GlaxoSmithKline (GSK) and approved for the treatment of chronic immune (idiopathic) thrombocytopenia (ITP) and hepatitis C associated thrombocytopenia. The aim of this study is to report the incidence of hepatic decompensation among eltrombopag user with chronic hepatitis C virus infection who are unable to initiate or maintain optimal interferon-based therapy due to thrombocytopenia.This study is a multi-center, prospective, observational studynested within the HCV Research UK study, and conducted to evaluate patients treated with eltrombopag. Patients will be followed for a period of up to 3 years after initiating eltrombopag, based on routine care, patients will be assessed regularly during interferon-based therapy and thereafter according to local standard practice.
• Study status:
  Finalised

Research institutions and networks

Institutions

University of Glasgow

Multiple centres: 40 centers are involved in the study

Study timelines

Date when funding contract was signed

Planned:31/10/2013

Actual:31/10/2013

Study start date

Planned:31/10/2014

Actual:12/08/2014

Date of final study report

Planned:31/12/2018

Actual:25/06/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)