Phase
Condition
Immune Thrombocytopenia (Itp)
Thrombosis
Dysfunctional Uterine Bleeding
Treatment
The best available therapy
Combined use of TPO-RAs with low-dose anti-CD20 antibody
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The patients have provided written informed consent prior to enrollment.
18-65 years old.
Diagnosed as ITP secondary to connective tissue diseases (including but not limitedto systemic lupus erythematosus, Sjogren's syndrome and rheumatoid arthritis),primary ITP with positive antinuclear antibody but not up to the diagnostic criteriaof connective tissue diseases, primary Evans syndrome, Evans syndrome secondary toconnective tissue diseases, and primary ITP with positive Coomb's test but not up tothe diagnostic criteria of Evans syndrome.
Platelet count<30 ×10^9/L at screening.
Patients who have received at least one first-line treatment of ITP (glucocorticoidand / or intravenous immunoglobulin) in the past, failed (poor efficacy, or failureto maintain efficacy, or relapse), or had contraindications, intolerance, or refusalof first-line treatment.
Treatment for ITP (including but not limited to glucocorticoids, recombinant humanthrombopoietin (rTPO)) must be completed before enrollment, or the dose must bestable or in a phase of reduction within 2 weeks before enrollment.Immunosuppressants (including but not limited to azathioprine, danazol, cyclosporineA, mycophenolate mofetil) must be finished before entering the group, or the dosemust be stable or in the reduction period within 3 months before entering the group.
Effective contraceptive measures will be taken during the clinical trial.
Exclusion
Exclusion Criteria:
Thrombocytopenia secondary to thyroid disease.
Patients with any prior history of arterial or venous thrombosis, and with any ofthe following risk factors: cancer, Factor V Leiden, ATIII deficiency, andantiphospholipid syndrome.
Those who had received anti-CD20 monoclonal antibody within 6 months or who hadpreviously failed to respond to low-dose anti-CD20 monoclonal antibody.
Patients who had failed to respond to the previous use of eltrombopag 75 mg once aday, hetrombopag 7.5mg once a day or avatrombopag 40mg once a day for more than 4weeks.
Patients who have received splenectomy within one year or have splenectomy planwithin one year.
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.
Patients with agranulocytosis (ANC <1× 10^9/L), or moderate and severe anemia (HGB < 90g/L). For patients with Evans syndrome, patients with HGB< 60g/L will be excluded.
Severe liver dysfunction (alanine aminotransferase or glutamic oxaloacetictransaminase > 3×ULN), or bilirubin level > 2×ULN except patients with Evanssyndrome.
Patients with severe cardiac or pulmonary dysfunction.
Severe renal damage (creatinine clearance < 50 ml/min).
There were 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 have participated in other experimental researches within one monthbefore enrollment.
Any other circumstances that the investigator considers that the patient is notsuitable to participate in the trial.
Study Design
Study Description
Connect with a study center
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin 300020
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.