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

• Status: Recruiting
• Trial end date: 2022-07-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital
• Collaborators: Henan Cancer Hospital; North China University of Technology Affiliated Hospital; Novartis; Qilu Hospital of Shandong University; Second Affiliated Hospital of Guangzhou Medical University; The Affiliated Hospital of Qingdao University; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; The First Affiliated Hospital of University of Science and Technology of China; The Second Affiliated Hospital of Kunming Medical University; The Second Hospital of Hebei Medical University; Tianjin First Central Hospital; Tianjin Medical University Second Hospital

Criteria

Inclusion Criteria:

• Signed written informed consent.

• Subject is ≥18 years old.

• Diagnosis of HBV-infection duration for at least 6 months prior to the study and have a platelet count of <30 ×109/L on Day 1 (or within 48 hours prior to dosing on Day 1).

• Complete blood count results: white blood cells, absolute neutrophils count and hemoglobin are within the laboratory normal range, but abnormalities caused by HBV infection can be accepted.

• Subject is practicing an acceptable method of contraception. Women of childbearing potential must have a negative serum pregnancy test in the whole study.

Exclusion Criteria:

• Liver cirrhosis (LC) defined as any of the following:

1. Any symptom or sign typical of hepatic decompensation: including but not limited to ascites, splenomegaly, dilation of periumbilical collateral veins, hepatic encephalopathy

2. Child-Pugh class B to C Biopsies are not required either for confirmation or for exclusion of LC, considering the high bleeding risk in these patients.

• Positive serology for HIV, hepatitis C virus (HCV), and/or hepatitis D virus (HDV).

• Pregnancy or lactation period.

• History of alcohol/drug abuse or dependence within 12 months of the study.

• History of thrombosis.

• The serum chemistry results exceed the upper laboratory normal range by more than 20%; except AST, ALT, GGT, ALP of CTCAE grade 1.

• Bone marrow examination conducted within 4 weeks prior to first dose reported an abnormal result, which in the opinion of the investigator makes the subject unsuitable for participation in the study.

• Pre-existing cardiac disease, including congestive heart failure of New York Heart Association [NYHA] Grade III/IV, arrhythmia requiring treatment or myocardial infarction within the last 6 months. No arrhythmia known to increase the risk of thrombotic events (e.g. atrial fibrillation), or patients with a QT >450msec or QTc > 480 for patients with a Bundle Branch Block.

• Subject has consumed aspirin, aspirin-containing compounds, salicylates, anticoagulants, quinine or non-steroidal anti-inflammatories (NSAIDs) for >3 consecutive days within 2 weeks prior to the study start and until the end of the study.

• Non-compliant patient

• Reluctance to take effective contraceptive measures during the trial

• History of solid organ or bone marrow transplant.