Romiplostim for Oral TPO-RA Resistant ITP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, open-label, single-arm study evaluating the safety and effectiveness of romiplostim in adults with ITP who failed prior oral TPO-RA therapy. Participants stop their current oral TPO-RA and receive weekly subcutaneous romiplostim, starting at 3 mcg/kg with possible weekly dose adjustments up to 10 mcg/kg over a 24-week period. The trial focuses on patients with persistently low platelets and prior intolerance or loss of response to oral TPO-RAs, to see if romiplostim can raise platelet counts and reduce bleeding risk. Primary outcome details are not provided in the summary, but the study tracks safety and platelet response over treatment and follow-up. Conducted across multiple centers in Jiangsu province, the study is sponsored by a major university hospital with local affiliated sites.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Age ≥18 years Diagnosed with primary immune thrombocytopenia (ITP) according to current guidelines

Failed prior oral TPO-RA therapy (eltrombopag, hetrombopag, or avatrombopag), defined as:

Platelet count persistently \<30×10⁹/L after ≥4 weeks of treatment at the maximum recommended or tolerated dose, OR Prior achieved response (platelet ≥50×10⁹/L) then lost response with platelet count \<30×10⁹/L on two consecutive visits (≥1 week apart), OR Intolerance to oral TPO-RA leading to discontinuation (with documented reason) Baseline platelet count \<30×10⁹/L (at least two measurements, ≥5 days apart) ECOG performance status 0-2 Willing and able to receive weekly subcutaneous injections and comply with study procedures For women of childbearing potential: negative pregnancy test at screening and agreement to use effective contraception during the study and for 3 months after the last dose Able to provide written informed consent

Exclusion Criteria:

Secondary ITP (e.g., associated with autoimmune diseases, lymphoproliferative disorders, drug-induced, or infections such as HIV/HCV/HBV) Known hypersensitivity to romiplostim or any of its excipients Prior treatment with romiplostim Received rituximab or other B-cell depleting therapy within 6 months prior to screening Received immunosuppressants (e.g., cyclosporine, mycophenolate mofetil, azathioprine, danazol) within 4 weeks prior to screening Splenectomy within 8 weeks prior to screening Use of corticosteroids (prednisone \>10 mg/day or equivalent) or IVIG within 2 weeks prior to screening History of bone marrow fibrosis (MF grade ≥2) or known reticulin fibrosis History of arterial or venous thromboembolic event (e.g., myocardial infarction, stroke, deep vein thrombosis, pulmonary embolism) within 6 months prior to screening Known thrombophilic conditions (e.g., antiphospholipid syndrome, protein C/S deficiency, ATIII deficiency) Severe hepatic impairment (ALT or AST \>3×ULN, or total bilirubin \>1.5×ULN) Severe renal impairment (creatinine clearance \<30 mL/min) New York Heart Association (NYHA) functional class III or IV heart failure Malignancy within 5 years prior to screening (except non-melanoma skin cancer, cervical carcinoma in situ, or ductal carcinoma in situ of the breast) Pregnancy or breastfeeding Participation in another interventional clinical trial within 30 days prior to screening Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study

Where it's running

• The First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: The First Affiliated Hospital of Soochow University
• Email: tianhong0718@163.com
• Phone: 86-0512-67781521

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.