Prolonged response after TPO-RA discontinuation in primary ITP: results of a prospective multicenter study.
Stéphanie Guillet, Etienne Crickx, Imane Azzaoui...
https://pubmed.ncbi.nlm.nih.gov/36893453Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID07133659
Exploring the Efficacy and Safety of a Lower Starting Dose of Avatrombopag in Adults with Immune Thrombocytopenia (ITP) - A Pilot Study
Led by Al-Mustansiriyah University · Updated on 2025-08-21
25
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore the safety and effectiveness of a modified lower starting dose of avatrombopag in adults with primary immune thrombocytopenia (ITP) who need second-line treatment. Avatrombopag, an oral medication that stimulates platelet production, is usually started at 20 mg daily, but this study investigates starting at 20 mg every other day to reduce the common issue of platelet count overshoot. The study is an open-label, single-center pilot trial sponsored by Al-Mustansiriyah University. Participants will begin treatment with avatrombopag 20 mg every other day for one week, followed by dose adjustments based on platelet counts. The study includes three phases: dose adjustment, maintenance, and dose tapering with follow-up, lasting up to 24 weeks of treatment. The goal is to assess the response to this lower starting dose and monitor safety, including bleeding complications and quality of life changes. Throughout the study, participants will have platelet levels and other health measures monitored regularly. Researchers will evaluate how quickly and effectively platelet counts respond, the rates of overshoot and treatment failure, and sustained response after stopping treatment at week 52. Safety and quality of life will also be tracked over the year. Overall participation may last up to 52 weeks, including treatment and follow-up phases.
CONDITIONS
Brief 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
You may qualify if you...
- Male or female aged 18 years or older
- Diagnosis of primary ITP with platelet count below 30 x10⁹/L within two weeks before inclusion
- Failure to respond or relapse after at least one cycle of dexamethasone or prednisone/prednisolone
- Clinical need for second or subsequent line platelet elevating therapy
- 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 risk of bleeding
- Females of child-bearing potential not using effective contraception during treatment
- Secondary ITP due to lymphoma, chronic lymphocytic leukemia, autoimmune disorders, immune deficiency, or certain viral infections
- Concomitant autoimmune hemolytic anemia or Evans syndrome
- Serious comorbidities that may worsen with study drug
- Active malignancy unless considered cured (with exceptions like certain skin cancers and carcinoma in situ)
- History of poor compliance, substance abuse, or psychiatric illness that affects ability to comply or consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months
Participants start avatrombopag 20 mg every other day for one week, followed by dose adjustments based on platelet count, continuing treatment for a total of 6 months.
Regular visits for dose adjustment and monitoring during treatment
Follow-up
Duration - Up to 6 months after treatment
Participants are monitored for safety, bleeding complications, and sustained response off-treatment after completing avatrombopag treatment.
Periodic visits up to week 52
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
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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Published Research Related To This Trial
Avatrombopag in immune thrombocytopenia: A real-world study of the Spanish ITP Group (GEPTI).
Cristina Pascual-Izquierdo, Blanca Sánchez-González, Mariana-Isabel Canaro-Hirnyk...
https://pubmed.ncbi.nlm.nih.gov/39394928Avatrombopag for adults with early versus chronic immune thrombocytopenia.
Zain M Virk, Rebecca K Leaf, David J Kuter...
https://pubmed.ncbi.nlm.nih.gov/38063420A phase 3 study of the efficacy and safety of avatrombopag in Japanese adults with chronic immune thrombocytopenia.
Hiroki Yamaguchi, Masaki Iino, Shugo Kowata...
https://pubmed.ncbi.nlm.nih.gov/40392465A phase 3, randomized, double-blind, active-controlled trial evaluating efficacy and safety of avatrombopag versus eltrombopag in ITP.
Michael D Tarantino, James B Bussel, Eun-Ju Lee...
https://pubmed.ncbi.nlm.nih.gov/37339869Avatrombopag for adult chronic primary immune thrombocytopenia: a randomized phase 3 trial in China.
Heng Mei, Hu Zhou, Ming Hou...
https://pubmed.ncbi.nlm.nih.gov/37700877Phase 3 randomised study of avatrombopag, a novel thrombopoietin receptor agonist for the treatment of chronic immune thrombocytopenia.
Wojciech Jurczak, Krzysztof Chojnowski, Jiří Mayer...
https://pubmed.ncbi.nlm.nih.gov/30191972Expert Report on Immune Thrombocytopenia: Current Diagnostics and Treatment - Recommendations from an Expert Group from Austria, Germany, and Switzerland.
Axel Matzdorff, Sonja R Alesci, Johanna Gebhart...
https://pubmed.ncbi.nlm.nih.gov/36787705American Society of Hematology 2019 guidelines for immune thrombocytopenia.
Cindy Neunert, Deirdra R Terrell, Donald M Arnold...
https://pubmed.ncbi.nlm.nih.gov/31794604Updated international consensus report on the investigation and management of primary immune thrombocytopenia.
Drew Provan, Donald M Arnold, James B Bussel...
https://pubmed.ncbi.nlm.nih.gov/31770441