Avatrombopag in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    52
  • sponsor
    Institute of Hematology & Blood Diseases Hospital
Updated on 12 August 2021
platelet count
glucocorticoids
thrombocytopenia
sjogren's syndrome
recombinant human thrombopoietin
eltrombopag
arthritis
lupus
evans syndrome
thrombopoietin receptor agonists
immune globulin
avatrombopag

Summary

This prospective, open-label, single-center, one-arm clinical trial aims at evaluating the efficacy and safety of avatrombopag in Chinese adult Immune Thrombocytopenia (ITP) patients with autoantibodies fail (due to intolerance or resistance) to eltrombopag or herombopag treatment.

Description

This prospective, open-label, single-center, one-arm clinical trial aims at evaluating the efficacy and safety of avatrombopag in Chinese adult ITP patients with autoantibodies fail (due to intolerance or resistance) to eltrombopag or herombopag treatment.

The subjects include ITP secondary to connective tissue diseases (including but not limited to systemic lupus erythematosus, Sjogren's syndrome and rheumatoid arthritis), primary ITP with positive antinuclear antibody but not up to the diagnostic criteria of connective tissue diseases, primary Evans syndrome, Evans syndrome secondary to connective tissue diseases, and primary ITP with positive Coomb's test but not up to the diagnostic criteria of Evans syndrome.

Fifty-two eligible subjects will be enrolled in this study. The dose will be adjusted according to the platelet count during the period from week 1 to week 12.

Details
Condition IDIOPATHIC THROMBOCYTOPENIC PURPURA, Autoimmune disease, Autoantibodies, CONNECTIVE TISSUE DISEASE, Immune Thrombocytopenia, Evan Syndrome, Connective Tissue Diseases, Evans Syndrome, autoimmune thrombocytopenia, connective tissue disorder
Treatment Avatrombopag
Clinical Study IdentifierNCT04993885
SponsorInstitute of Hematology & Blood Diseases Hospital
Last Modified on12 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

The patients have provided written informed consent prior to enrollment
Men and women greater than or equal to 18 years of age
Diagnosed as ITP secondary to connective tissue diseases (including but not limited to systemic lupus erythematosus, Sjogren's syndrome and rheumatoid arthritis), primary ITP with positive antinuclear antibody but not up to the diagnostic criteria of connective tissue diseases, primary Evans syndrome, Evans syndrome secondary to connective tissue diseases, and primary ITP with positive Coomb's test but not up to the diagnostic criteria of Evans syndrome
Platelet count<30 10^9/L at screening
Patients who have previously failed to receive Eltrombopag or Herombopag [poor efficacy (Eltrombopag 75 mg/d or Herombopag 7.5 mg/D, at least 4 weeks), or the efficacy cannot be maintained], or who have contraindications, can not tolerate or refuse Eltrombopag or Herombopag treatment
Treatment for ITP (including but not limited to glucocorticoids, recombinant human thrombopoietin, and other thrombopoietin receptor agonists other than Avatrombopag) must be completed before enrollment, or the dose must be stable or in a phase of reduction within 2 weeks before enrollment
Effective contraceptive measures will be taken during the clinical trial

Exclusion Criteria

Patients with active thyroid disease requiring treatment
Patients with any prior history of arterial or venous thrombosis within 3 months, and with any of the following risk factors: cancer, Factor V Leiden, ATIII deficiency, or patients who are using anticoagulants or antiplatelet drugs at the beginning of screening
Those who had received rituximab within 3 months
Patients who had failed to respond to the previous use of Avatrombopag (40mg once a day for more than 4 weeks)
Subjects known to be allergic to Avatrombopag or any of its excipients
Patients who had received splenectomy within 3 months or have splenectomy plan within 3 months
Patients with lupus encephalopathy or lupus nephritis
Patients with cataract
Patients with infectious fever (including but not limited to pulmonary infection) within 1 month or with active infection during screening
Existing hepatitis B virus, hepatitis C virus replication or HIV infection
Severe liver dysfunction (alanine aminotransferase or glutamic oxaloacetic transaminase > 3ULN)
Patients with severe cardiac or pulmonary dysfunction
Severe renal damage (creatinine clearance < 30 ml/min)
There are surgical planners during the study
History of psychiatric disorder
Pregnant or lactating women or those planning to be pregnant during the trial
Patients with a history of drug/alcohol abuse (within 2 years before the study)
Patients that had participated in other experimental researches within one month before enrollment
Any other circumstances that the investigator considers that the patient is not suitable to participate in the trial
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