Status:
RECRUITING
Exploring the Efficacy, Safety of a Modified Starting Dosage of Avatrombopag in Immune Throbocytopenia (ITP) - a Pilot Study
Lead Sponsor:
Al-Mustansiriyah University
Conditions:
ITP - Immune Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Detailed Description
Avatrombopag is an oral thrombopoietin receptor agonist that is licensed for chronic ITP. Avatrombopag is administered at a starting dose of 20 mg daily. Overshooting of platelet count is a frequent p...
Eligibility Criteria
Inclusion
- Male or female aged ≥18 years.
- 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.
- Clinical need for second (subsequent) line treatment with a platelet elevating therapy assessed by the physician in charge.
- Signed and dated written informed consent.
Exclusion
- Previous treatment with TPO-RA.
- Pregnancy or lactation.
- Patients with active serious bleeding or at high risk of bleeding as judged by physician in charge.
- Females of child-bearing potential refusing to follow effective contraceptive methods (as described in SmPC) during treatment with Avatrombopag.
- Secondary ITP defined as ITP secondary to lymphoma or chronic lymphocytic leukemia; ITP secondary to the following autoimmune disorders Systemic Lupus Erythematosus or Antiphospholipid Syndrome; ITP secondary to Common Variable Immune Deficiency; ITP secondary to the following viral infections eg Human Immunodeficiency Virus.
- Concomitant autoimmune hemolytic anemia, Evans syndrome.
- Presence of any serious comorbidity where the condition may worsen the study drugs.
- Presence of active malignancy unless deemed cured by adequate treatment. Participants with the following neoplastic conditions can be included:
- Monoclonal gammopathy of undetermined significance (MGUS) or monoclonal B lymphocytosis of undetermined significance (MBUS)
- Basal/squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix
- Carcinoma in situ of the breast
- Incidental histological finding of prostate cancer (TNM stage T1a or T1b)
- Patients with history of poor compliance or history of alcohol/drug abuse or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent.
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Key Trial Info
Start Date :
June 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 8 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT07133659
Start Date
June 8 2025
End Date
July 8 2027
Last Update
August 21 2025
Active Locations (1)
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1
hematology center / Medical City
Baghdad, Iraq, 10016