to Evaluate the Efficacy and Safety of Eltrombopag for Immune Thrombocytopenia With Chronic HBV Infection

Summary

Primary Objective: To evaluate the efficacy of 6-week Eltrombopag to treat immune thrombocytopenia with chronic hepatitis B virus infection. Secondary Objective: To evaluate the efficacy and safety of 6-week and 22-week Eltrombopag to treat immune thrombocytopenia with chronic hepatitis B virus infection.

Conditions

• Thrombocytopenia Purpura
• Chronic HBV Infection

Interventions

DRUG

Eltrombopag

subjects will initiate treatment with 25 mg eltrombopag. Platelet counts is obtained weekly and dose adjustment should be done according to platelet counts. and maximum dose should not exceed 75 mg daily. Subjects whose platelet count between 50\~150×109/L，the eltrombopag dose Maintain. platelet count between 150\~250×109/L, need to reduce the dose of eltrombopag to the next lower dose or lower frequency. Subjects whose platelet count exceeds 250×109/L at any point during the treatment period, must have eltrombopag interrupted and increase the frequency of platelet monitoring to twice weekly, until platelet counts fall below 100×109/L.

Sponsors & Collaborators

• Novartis

  collaborator INDUSTRY

• Qilu Hospital of Shandong University

  collaborator OTHER

• The Second Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Tianjin First Central Hospital

  collaborator OTHER

• Tianjin Medical University Second Hospital

  collaborator OTHER

• Henan Cancer Hospital

  collaborator OTHER_GOV

• The Second Hospital of Hebei Medical University

  collaborator OTHER

• North China University of Science and Technology

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• The First Affiliated Hospital of University of Science and Technology of China

  collaborator OTHER

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  collaborator OTHER

• Second Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Institute of Hematology & Blood Diseases Hospital, China

  lead OTHER

Principal Investigators

• lei zhang, MD · Chinese Academy of Medical Science and Blood Disease Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-12-04

Primary Completion

2022-06-30

Completion

2022-09-30

FDA Drug

Yes

Countries

• China

Study Locations