WEUSKOP7136: A global, prospective cohort study to evaluate the 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 (201111)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/20455
• EU PAS number:
  EUPAS7201
• Study ID:
  20455
• Official title and acronym:
  WEUSKOP7136: A global, prospective cohort study to evaluate the 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 (201111)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  Greece

  Italy

  Russian Federation

  Spain

  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 assess the safety and effectiveness of eltrombopag in routine clinical practice in patients with HCV who are unable to initiate or maintain optimal interferon-based therapy due to thrombocytopenia.This study is a global, multi-center, prospective, observational studyconducted to evaluate clinical outcomes and treatment patterns in HCV patients treated with eltrombopag. Patients will be followed for a period of 3 years after initiating eltrombopag, based on routine care, patients will be assessed approximately every 3 months or according to routine practice during interferon-based therapy and then approximately every 6 months thereafter according to local standard practice.
• Study status:
  Finalised

Research institution and networks

Institutions

Novartis Pharmaceuticals

Multiple centres: 40 centres 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: 28/11/2014

Actual: 16/07/2014

Date of final study report

Planned: 30/11/2019

Actual: 09/06/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis

Study protocol

Initial protocol

Epi-WEUSKOP7136-protocol-redact

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)