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Proposal 951

Title of the Proposed Research

Optimized Eltrombopag Treatment of Hepatitis C virus-related thrombocytopenia

Lead Researcher

Mohammad Saleh

Affiliation

The University of Jordan
Amman, JO

Funding Source

None

Potential Conflicts of Interest

None

Data Sharing Agreement Date

21 April 2014

Lay Summary

Globally, Hepatitis C virus (HCV) infection has an estimated prevalence of 2.35 per cent in 2011 (160 million chronically infected individuals). Thrombocytopenia is one of the most frequent hematological alterations in patients with chronic HCV. The usual protocol to treat HCV-related thrombocytopenia is to reduce the interferon dose if platelet count falls to < 30 × 109/L. Interferon therapy should be discontinued if platelet count falls to < 20 × 109/L. Recently, eltrombopag has been found to be effective mean to raise platelet counts in thrombocytopenic patients with chronic HCV infection allowing otherwise ineligible or marginal patients to begin and maintain antiviral therapy.

The objective of the present project is to develop an optimal dosing algorithm of eltrombopag. We will identify the pharmacokinetic/pharmacodynamic (PK/PD) and physiologic factors important in predicting and maximizing eltrombopag’s effect in the treatment of Hepatitis C virus-related thrombocytopenia. Hence, the identified factors can be used to develop a dosing algorithm of eltrombopag.

This project is expected to improve patient care by identifying proper treatment strategies and (sub)populations that may (or may not) benefit from eltrompobag, and hence avoid antiviral therapy discontinuation.

The experimental design involves two studies that are: multicentre two-part study, consisting of an open-label (OL), Pre-Antiviral Treatment Phase (Part 1) and a randomised, double-blind (DB), placebo controlled, Antiviral Treatment Phase (Part 2). The collected data will be used to build a model that describes the relation between the administered eltrombopag dose and the change in platelets count. The main finding will be communicated in the form of an eltrombopag dosing algorithm.

Study Data Provided

Study TPL103922: Randomised, placebo-controlled, multi-centre study to assess the efficacy and safety of eltrombopag in thrombocytopenic subjects with hepatitis C virus (HCV) infection who are otherwise eligible to initiate antiviral therapy (peginterferon alfa-2a plus ribavirin)
Study TPL108390: Randomised, placebo-controlled, multi-centre study to assess the efficacy and safety of eltrombopag in thrombocytopenic subjects with hepatitis C virus (HCV) infection who are otherwise eligible to initiate antiviral therapy (peginterferon alfa-2b plus ribavirin)

Statistical Analysis Plan

This will be added after the research is published.

Publication Citation