Study identification

PURI

https://redirect.ema.europa.eu/resource/18675

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 institution and networks

Institutions

Multiple centres: 100 centers are involved in the study

Contact details

Clinical Disclosure Officer Clinical Disclosure Officer

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Novartis
Study protocol
Initial protocol

Epi-Prot-WEUSKOP7135-protocol-redact

English (679.16 KB - PDF)View document
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)