Actively Recruiting
Exploring the Efficacy, Safety of a Modified Starting Dosage of Avatrombopag in Immune Throbocytopenia (ITP) - a Pilot Study
Led by Al-Mustansiriyah University · Updated on 2025-08-21
25
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Exploring the Efficacy, Safety of a Modified Starting Dosage of Avatrombopag in Immune Throbocytopenia (ITP) - a Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 6518 years
- Diagnosis of primary ITP with platelet count below 30 x10^9/L within two weeks before joining
- Failure to respond or relapse after at least one cycle of dexamethasone or prednisone/prednisolone treatment
- Clinical need for second or later line platelet-elevating treatment as determined by physician
- Signed and dated informed consent
You will not qualify if you...
- Previous treatment with thrombopoietin receptor agonists (TPO-RA)
- Pregnancy or breastfeeding
- Active serious bleeding or high bleeding risk as judged by physician
- Females of child-bearing potential not using effective contraception during avatrombopag treatment
- Secondary ITP caused by lymphoma, chronic lymphocytic leukemia, certain autoimmune disorders, immune deficiency, or specific viral infections
- Coexisting autoimmune hemolytic anemia or Evans syndrome
- Serious other medical conditions that may worsen with study drug
- Active cancer unless considered cured; certain low-risk skin, cervical, breast, or prostate cancers allowed
- History of poor compliance, alcohol/drug abuse, or psychiatric illness interfering with study participation or consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
hematology center / Medical City
Baghdad, Iraq, 10016
Actively Recruiting
Research Team
A
Alaa Alwan, MD
CONTACT
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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