Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT07133659

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

hematology center / Medical City

Baghdad, Iraq, 10016

Actively Recruiting

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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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