A Phase 2 interventional study of Avatrombopag in Immune Thrombocytopenia, Autoantibodies and Evan Syndrome, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-24.
Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Phase 2, Interventional, and Treatment
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.
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.
521 studies on the registry are indexed under Purpura, Thrombocytopenic, Idiopathic; 158 are open to participants now.
This study's planned enrollment of 52 is below the median of 58 across 383 interventional studies indexed under Purpura, Thrombocytopenic, Idiopathic.
Browse Purpura, Thrombocytopenic, Idiopathic studies →Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 402 studies on the registry; 296 are open to participants now.
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Exclusion Criteria:
Fifty-two subjects will be enrolled with the indicated treatment dose of avatrombopag
Drug: Avatrombopag
The subjects will receive avatrombopag treatment with an initial dose of 40mg once a day. Platelet counts will be obtained weekly during the first 4 weeks and then every 2 weeks until week 12 after treatment. The dose adjustment range is 20 mg per week to 40 mg per day to maintain the platelet level between 30×10\^9/L and 200×10\^9/L. If the platelet count does not reach to 30×10\^9/L after taking avatrombopag 40mg once a day for 4 consecutive weeks, the treatment will be stopped.
Platelet response
Percentage of participants achieving a platelet count \>=30×10\^9/L and at least doubling of the baseline count within 12 weeks of treatment.
Time frame: From the start of study treatment (Day 1) up to the end of week 12.
Platelet response
Proportion of subjects who achieve response (R) within 1, 2, 4 and 8 weeks of treatment.
Time frame: From the start of study treatment (Day 1) up to the end of week 12.
Platelet response
Proportion of subjects who achieve complete response (CR) within 4, 8 and 12 weeks of treatment.
Time frame: From the start of study treatment (Day 1) up to the end of week 12.
Duration of platelet response
Proportion of subjects with a platelet count \>=30×10\^9/L for at least 4 consecutive weeks during the 12 week treatment period without remedial treatment.
Time frame: From the start of study treatment (Day 1) up to the end of week 12.
Platelet response
Percentage of participants achieving a platelet count \>=50×10\^9/L within 12 weeks of treatment.
Time frame: From the start of study treatment (Day 1) up to the end of week 12.
Time to platelet response
Time to response is defined as time from the start of treatment to the first time of achieving a platelet count \>= 30×10\^9/L and at least doubling of the baseline count during the whole 12 weeks.
Time frame: From the start of study treatment (Day 1) up to the end of week 12.
Duration of platelet response
Total duration of time a participant with a response of R.
Time frame: From the start of study treatment (Day 1) up to the end of week 12.
Proportion of patients receiving remedial treatment.
Proportion of patients receiving remedial treatment.
Time frame: From the start of study treatment (Day 1) up to the end of week 12.
Bleeding score
The incidence and grade of bleeding symptoms according to the World Health Organization Bleeding Scale.
Time frame: From the start of study treatment (Day 1) up to the end of week 12.
Changes of disease activity index in patients with systemic lupus erythematosus
The proportion of subjects with improvement of disease activity index in patients with systemic lupus erythematosus according to the SLEDAI standard.
Time frame: From the start of study treatment (Day 1) up to the end of week 12.
The improvement of symptoms
The proportion of subjects with improvement of symptoms including skin symptom, joint pain, dry mouth and dry eyes.
Time frame: From the start of study treatment (Day 1) up to the end of week 12.
Improvement in immune indexes
The proportion of subjects with improvement immune indexes including antinuclear antibody, extractable nuclear antigens spectrum and Coomb's test.
Time frame: From the start of study treatment (Day 1) up to the end of week 12.
Discontinuation rate of glucocorticoids
The proportion of subjects with discontinuation use of glucocorticoids.
Time frame: From the start of study treatment (Day 1) up to the end of week 12.
Functional assessment of chronic illness therapy-fatigue
In all participants, functional assessment of chronic illness therapy-fatigue questionnaire will be used to assess the health related quality of life before and after treatment.
Time frame: From the start of study treatment (Day 1) up to the end of week 12.
ITP-Patient Assessment Questionnaire
In all participants, ITP-Patient Assessment Questionnaire will be used to assess the health related quality of life before and after treatment.
Time frame: From the start of study treatment (Day 1) up to the end of week 12.
Incidence of Toxicity
The proportion of subjects with specific pre-defined toxicity, including headache, fever, nausea and abdominal pain, and unpredictable toxicity.
Time frame: From the start of study treatment (Day 1) up to the end of week 12.
Ran from Sep 2021 to primary completion in Jul 2024, 34 months.
Of 67 phase 2 interventional studies under Purpura, Thrombocytopenic, Idiopathic, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 41. This study's 34 months is close to that.
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