Last updated: June 24, 2021
Sponsor: Shandong University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Dysfunctional Uterine Bleeding
Idiopathic Thrombocytopenic Purpura (Itp)
Immune (Idiopathic) Thrombocytopenic Purpura (Itp)
Treatment
N/AClinical Study ID
NCT04949009
SKX-2007
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Aged 18+ years, male or female;
- Ever been diagnosed as ITP patients. The diagnostic criteria comply with the "ChineseGuidelines for the Diagnosis and Treatment of Adult Primary Immune Thrombocytopenia (2020 Edition)"
- At least 2 consecutive blood tests showed a decrease in platelet count; noobvious abnormality in the morphology of blood cells by peripheral blood smearmicroscopy.
- Spleen is generally not enlarged.
- Bone marrow examination: the morphological characteristics of bone marrow cellsin ITP patients were increased or normal megakaryocytes with maturationdisorders.
- Other secondary thrombocytopenia must be excluded: autoimmune diseases, thyroiddisease, lymphoproliferative disorders, myelodysplastic syndrome (MDS), aplasticanemia (AA), various malignant hematologic diseases, tumor infiltration, Chronicliver disease, hypersplenism, common variant immunodeficiency disease (CVID),infection, vaccination causing secondary thrombocytopenia; Thrombocytopenia dueto depletion; Drug induced thrombocytopenia; Alloimmune thrombocytopenia;Thrombocytopenia during pregnancy; Congenital thrombocytopenia andpseudo-thrombocytopenia;
- ECOG general status score ≤ 2;
- Platelet count < 30×10^9/L;platelet count ≥< 30×10^9/L accompanied by active bleeding;If the platelet count is around 30×10^9/L and no active bleeding, a second examinationmust be performed to further confirm the platelet count.
- Voluntarily signed the informed consent.
- Any other circumstances that the investigator considers appropriate for the patient toparticipate in the study.
Exclusion
Exclusion Criteria:
- Patients with secondary thrombocytopenia.
- Currently receiving other TPO-RAs, rhIL-11 and rhTPO treatment, and subjects areunwilling to switch to avatrombopag treatment.
- Patients with severe insufficiency of heart, lung, liver and kidney.
- Pregnant or breast-feeding, or contraceptive measures cannot be taken during thetrial.
- Subjects participated in clinical studies of other investigational drugs or deviceswithin 30 days prior to screening.
- Having a history of psychotropic drug abuse and unable to quit or having mentaldisorders.
- Having significant factors that affect the absorption of oral drugs, such as inabilityto swallow, chronic diarrhea and intestinal obstruction, etc.
- Subject is allergic to avatrombopag or any of its excipients;
- Any other circumstances that the investigator considers inappropriate for the patientto participate in the study.
Study Design
Total Participants: 400
Study Start date:
March 01, 2021
Estimated Completion Date:
March 31, 2022
Study Description
Connect with a study center
Qilu Hospital, Shandong University
Jinan, Shandong
ChinaActive - Recruiting
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