Actively Recruiting
Efficacy and Safety of Avatrombopag in Adult Immune Thrombocytopenia Patients with Autoantibodies Who Failed Eltrombopag or Herombopag Treatment in a Single-Center Prospective Trial
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-02-24
52
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of avatrombopag in adult Chinese patients with Immune Thrombocytopenia (ITP) who have autoantibodies and have not responded well or cannot tolerate treatments with eltrombopag or herombopag. This is a phase 2, open-label, single-center, one-arm clinical trial focusing on patients with various forms of ITP, including those linked to connective tissue diseases and Evans syndrome variants. Participants will receive avatrombopag starting at 40 mg once daily. Platelet counts will be monitored weekly during the first four weeks and then every two weeks up to week 12. Doses may be adjusted between 20 mg and 40 mg daily to keep platelet levels within a target range. If platelet counts remain low after four weeks at the initial dose, treatment will be discontinued. Throughout the 12-week treatment period, researchers will assess platelet response, duration, and time to response. Additional measurements include bleeding scores, disease activity in systemic lupus erythematosus, symptom improvements, immune function, glucocorticoid discontinuation, fatigue, and patient-reported outcomes. Safety and efficacy will be closely monitored during this time to understand avatrombopag's impact on these patients.
CONDITIONS
Brief Title
Avatrombopag in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must provide written informed consent before joining.
- Men and women aged 18 years or older.
- Diagnosed with ITP secondary to connective tissue diseases (like lupus, Sjogren's syndrome, rheumatoid arthritis), primary ITP with positive antinuclear antibody not meeting connective tissue disease criteria, primary Evans syndrome, Evans syndrome secondary to connective tissue diseases, or primary ITP with positive Coomb's test not meeting Evans syndrome criteria.
- Platelet count less than 30 x 10^9/L at screening.
- Previous failure, intolerance, or contraindication to eltrombopag or herombopag treatment.
- Completed or stable treatment for ITP (excluding avatrombopag) within 2 weeks before enrollment.
- Use effective contraceptive methods during the trial.
You will not qualify if you...
- Active thyroid disease needing treatment.
- History of arterial or venous thrombosis within 3 months or risk factors like cancer, Factor V Leiden, ATIII deficiency, or use of anticoagulants or antiplatelet drugs at screening.
- Received rituximab within 3 months.
- Previously failed to respond to avatrombopag at 40 mg daily for more than 4 weeks.
- Allergy to avatrombopag or its ingredients.
- Splenectomy within 3 months or planned within 3 months.
- Lupus encephalopathy or lupus nephritis.
- Cataract.
- Infectious fever or active infection within 1 month.
- Active hepatitis B, hepatitis C replication, or HIV infection.
- Severe liver dysfunction (liver enzymes over 3 times normal).
- Severe heart or lung problems.
- Severe kidney damage (creatinine clearance below 30 ml/min).
- Planned surgery during the study.
- History of psychiatric disorder.
- Pregnant, breastfeeding, or planning pregnancy during the trial.
- History of drug or alcohol abuse within 2 years.
- Participation in other experimental studies within 1 month.
- Any other condition deemed unsuitable by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 weeks
Participants receive avatrombopag treatment with dose adjustments based on platelet count to maintain safe levels.
Weekly visits for the first 4 weeks, then visits every 2 weeks until week 12
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
R
Rongfeng Fu, M.D.
L
Lei Zhang, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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