NCT07133659 Exploring the Efficacy, Safety of a Modified Starting Dosage of Avatrombopag in Immune Throbocytopenia (ITP) - a Pilot Study
| NCT ID | NCT07133659 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Al-Mustansiriyah University |
| Condition | ITP - Immune Thrombocytopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-06-08 |
| Primary Completion | 2026-07-08 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a single-center, open label pilot trial where patients with primary ITP who require second line treatment will be offered avatrombopag at a reduced starting dose, adjusted thereafter according to the response and continued for up to 24 weeks. The study aims to acquire experience on use of avatrombopag and explore the efficacy and safety of lower starting dose of avatrombopag
Eligibility Criteria
Inclusion Criteria: 1. Male or female aged ≥18 years. 2. Diagnosis of primary ITP and having a platelet count of \< 30 x109/L measured within two weeks prior to inclusion with failure to achieve response or relapse after at least one cycle of dexamethasone (20-40 mg daily for 4 days) or prednisone /prednisolone (1 mg/kg for at least two weeks). Shorter courses or lower doses are allowed if discontinued or modified due to side effects. 3. Clinical need for second (subsequent) line treatment with a platelet elevating therapy assessed by the physician in charge. 4. Signed and dated written informed consent. Exclusion Criteria: 1. Previous treatment with TPO-RA. 2. Pregnancy or lactation. 3. Patients with active serious bleeding or at high risk of bleeding as judged by physician in charge. 4. Females of child-bearing potential refusing to follow effective contraceptive methods (as described in SmPC) during treatment with Avatrombopag. 5. Secondary ITP defined as ITP secondary to lymphoma o