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

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ClinicalTrials.gov Identifier: NCT03664518
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : March 5, 2019
Sponsor:
Collaborators:
Novartis
Qilu Hospital of Shandong University
The Second Affiliated Hospital of Kunming Medical University
Tianjin First Central Hospital
Tianjin Medical University Second Hospital
Henan Cancer Hospital
Information provided by (Responsible Party):
Zhang Lei, Institute of Hematology & Blood Diseases Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Thrombocytopenia Purpura Chronic HBV Infection Drug: Eltrombopag Phase 2

Detailed Description:

This is a single-arm phase II study to evaluate the efficacy and safety of Eltrombopag to treat thrombocytopenia associated with chronic hepatitis B virus infection.

This study includes two stages. In Stage 1 (Week 1 to Week 6), the short-term efficacy, safety and tolerability of Eltrombopag is evaluated. At the end of Stage 1, the subjects who can benefit from Eltrombopag treatment (platelet count ≥ 50×109/L) can enter a 16-week prolonged stage (Stage 2) to evaluate longer-term efficacy and safety.

The starting dose of Eltrombopag is 25 mg once daily, and the dose may be increased by 25 mg once daily every two weeks if the desired platelet response (>50×109/L) is not achieved. The daily dose should not exceed 75 mg.

In Stage 1, weekly visits are required during the first 6 weeks of the study. In Stage 2, platelet counts will be obtained weekly during dose adjustment and every 4 weeks following establishment of a stable dose of Eltrombopag (stable dose is defined as the dose which remains unchanged for at least 2 weeks).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Single-arm Study to Evaluate the Efficacy and Safety of Eltrombopag for Thrombocytopenia in Chinese Patients With Chronic HBV Infection
Actual Study Start Date : December 4, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Eltrombopag

Arm Intervention/treatment
Experimental: Eltrombopag
58 enrolled patients are picked up to take eltrombopag at the indicated dose.
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.




Primary Outcome Measures :
  1. Proportion of subjects with a platelet count ≥ 50×109/L at Day 43 [ Time Frame: 6 weeks ]
    The proportion of subjects with a platelet count ≥ 50×109/L at Day 43 after the first 6 weeks of Eltrombopag treatment (Stage 1)


Secondary Outcome Measures :
  1. Response rate of treatment [ Time Frame: 22 weeks ]
    Response rate including: a) the proportion of subjects achieving platelet counts ≥ 50×109/L at least once during the first 6 weeks (stage 1); b) the proportion of subjects whose platelet counts ≥ 30×109/L and at least two times of baseline platelet count at least once during the treatment.

  2. Bleeding in two stages [ Time Frame: 22 weeks ]
    according to the WHO bleeding grades to estimate the incidence and severity of bleeding symptoms during the treatment.

  3. The duration time with Platelet count ≥ 50×109/L [ Time Frame: 22 weeks ]
    Total duration of time a subject had a platelet count ≥ 50×109/L during treatment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664518


Contacts
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Contact: yueting huang, MD 13920284261 huangyueting@ihcams.ac.cn
Contact: lei zhang, MD 13502118379 zhanglei1@ihcams.ac.cn

Locations
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China, Tianjin
Ethics Committee of Blood disease hospital, Chinese Academy of Medical Sciences Recruiting
Tianjin, Tianjin, China, 300020
Contact: Lijun Liu, Master    +8613920927593    liulijun@ihcams.ac.cn   
Sponsors and Collaborators
Institute of Hematology & Blood Diseases Hospital
Novartis
Qilu Hospital of Shandong University
The Second Affiliated Hospital of Kunming Medical University
Tianjin First Central Hospital
Tianjin Medical University Second Hospital
Henan Cancer Hospital
Investigators
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Principal Investigator: lei zhang, MD Chinese Academy of Medical Science and Blood Disease Hospital

Publications of Results:
Other Publications:
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Responsible Party: Zhang Lei, vice Director of Thrombosis and Hemostasis Center, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT03664518     History of Changes
Other Study ID Numbers: IHBDH-IIT2018006
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Thrombocytopenia
Purpura
Purpura, Thrombocytopenic
Blood Platelet Disorders
Hematologic Diseases
Blood Coagulation Disorders
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Immune System Diseases