WEUSKOP7135: A prospective, observational cohort study nested within the HCV TARGET study to evaluate real-world use (201110)

Study identification

• EU PAS number:
  EUPAS7309
• Study ID:
  18675
• Official title and acronym:
  WEUSKOP7135: A prospective, observational cohort study nested within the HCV TARGET study to evaluate real-world use (201110)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  France

  Germany

  Israel

  Puerto Rico

  Spain

  United Kingdom

  United States
• 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 TARGET 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

Novartis Pharmaceuticals

Multiple centres: 100 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:31/07/2018

Actual:25/08/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis

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)