Avatrombopag in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Avatrombopag
Treatment groups
52 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov