Exploring the Efficacy, Safety of a Modified Starting Dosage of Avatrombopag in Immune Throbocytopenia (ITP) - a Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Iraq
hematology center / Medical City
RECRUITING
Baghdad
Contact Information
Primary
Alaa Alwan, MD
ala_sh73@yahoo.com
770 274 3114
Time Frame
Start Date: 2025-06-08
Estimated Completion Date: 2027-07-08
Participants
Target number of participants: 25
Treatments
Experimental: Avatrombopag
Description: Patients will start on avatrombopag 20 mg every other day for a week then the dose will be readjusted according to the platelet count.
Sponsors
Leads: Al-Mustansiriyah University

This content was sourced from clinicaltrials.gov