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

NCT03664518 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: IIT2018006
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with a platelet count ≥ 50×109/L at Day 43

  The proportion of subjects with a platelet count ≥ 50×109/L at Day 43 after the first 6 weeks of Eltrombopag treatment (Stage 1)

  6 weeks

Secondary Outcomes (3)

• Response rate of treatment

  22 weeks

• Bleeding in two stages

  22 weeks

• The duration time with Platelet count ≥ 50×109/L

  22 weeks

Study Arms (1)

Eltrombopag

EXPERIMENTAL

58 enrolled patients are picked up to take eltrombopag at the indicated dose.

Drug: Eltrombopag

Interventions

Eltrombopag DRUG

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.

Eltrombopag

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Liver cirrhosis (LC) defined as any of the following:
• Any symptom or sign typical of hepatic decompensation: including but not limited to ascites, splenomegaly, dilation of periumbilical collateral veins, hepatic encephalopathy
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Ethics Committee of Blood disease hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300020, China

Location

Related Publications (9)

• Ott JJ, Stevens GA, Groeger J, Wiersma ST. Global epidemiology of hepatitis B virus infection: new estimates of age-specific HBsAg seroprevalence and endemicity. Vaccine. 2012 Mar 9;30(12):2212-9. doi: 10.1016/j.vaccine.2011.12.116. Epub 2012 Jan 24.

  PMID: 22273662 BACKGROUND

• Zhang Y, Zhang H, Elizabeth A, Liu XQ. Epidemiology of hepatitis B and associated liver diseases in china. Chin Med Sci J. 2013 Jan;27(4):243-8. doi: 10.1016/s1001-9294(13)60009-7.

  PMID: 23294591 BACKGROUND

• Toghill PJ, Green S, Ferguson F. Platelet dynamics in chronic liver disease with special reference to the role of the spleen. J Clin Pathol. 1977 Apr;30(4):367-71. doi: 10.1136/jcp.30.4.367.

  PMID: 853132 BACKGROUND

• Aref S, Mabed M, Selim T, Goda T, Khafagy N. Thrombopoietin (TPO) levels in hepatic patients with thrombocytopenia. Hematology. 2004 Oct-Dec;9(5-6):351-6. doi: 10.1080/10245330400010620.

  PMID: 15763973 BACKGROUND

• Afdhal N, McHutchison J, Brown R, Jacobson I, Manns M, Poordad F, Weksler B, Esteban R. Thrombocytopenia associated with chronic liver disease. J Hepatol. 2008 Jun;48(6):1000-7. doi: 10.1016/j.jhep.2008.03.009. Epub 2008 Mar 31.

  PMID: 18433919 BACKGROUND

• Bussel JB, Marks KM. How effective is eltrombopag for the treatment of thrombocytopenia in patients with HCV infection? Nat Clin Pract Gastroenterol Hepatol. 2008 Aug;5(8):424-5. doi: 10.1038/ncpgasthep1185. Epub 2008 Jul 8. No abstract available.

  PMID: 18607406 BACKGROUND

• Yang R, Li J, Jin J, Huang M, Yu Z, Xu X, Zhang X, Hou M. Multicentre, randomised phase III study of the efficacy and safety of eltrombopag in Chinese patients with chronic immune thrombocytopenia. Br J Haematol. 2017 Jan;176(1):101-110. doi: 10.1111/bjh.14380. Epub 2016 Oct 13.

  PMID: 27734464 RESULT

• Bussel JB, Cheng G, Saleh MN, Psaila B, Kovaleva L, Meddeb B, Kloczko J, Hassani H, Mayer B, Stone NL, Arning M, Provan D, Jenkins JM. Eltrombopag for the treatment of chronic idiopathic thrombocytopenic purpura. N Engl J Med. 2007 Nov 29;357(22):2237-47. doi: 10.1056/NEJMoa073275.

  PMID: 18046028 RESULT

• Giannini EG, Afdhal NH. Eltrombopag in patients with chronic liver disease. Expert Opin Pharmacother. 2013 Apr;14(5):669-78. doi: 10.1517/14656566.2013.775249. Epub 2013 Mar 4.

  PMID: 23452139 RESULT

MeSH Terms

Conditions

Purpura, Thrombocytopenic

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• lei zhang, MD

  Chinese Academy of Medical Science and Blood Disease Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2018
• First Posted: September 10, 2018
• Study Start: December 4, 2018
• Primary Completion: June 30, 2022
• Study Completion: September 30, 2022
• Last Updated: February 11, 2026

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: From 12 months 36 months after study completion.
• Access Criteria: Upon request to PI.

Locations

CN (1)