Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07400250
Brief Summary:
To evaluate whether orelabrutinib combined with romiplostim N01 can improve the quality of remission, increase the probability of successful drug withdrawal, and prolong the time to treatment failure in patients with primary immune thrombocytopenia (ITP) who have received at least one line of prior therapy.
Detailed Description:
This is a prospective, single-arm, open-label Phase II study, enrolling adult patients with chronic primary immune thrombocytopenia (ITP) who failed first-line therapy. The study evaluates the efficacy and safety of orelabrutinib combined with romiplostim N01, focusing on the treatment regimen as follows:
* Core Treatment Phase (Weeks 1-24) Patients receive orelabrutinib 50mg orally once daily (fixed dose) and romiplostim N01 subcutaneously. Romiplostim N01 starts at 250ug/week (≈3ug/Kg) and is titrated within 1-10ug/Kg/week to maintain platelet count (PLT) at 50-200×10⁹/L. Dose adjustments: increase by 1-3ug/Kg/week if PLT \<50×10⁹/L; decrease by 1-3ug/Kg/week if PLT 200-400×10⁹/L; suspend if PLT \>400×10⁹/L. Patients with PLT \<50×10⁹/L after 28 days of maximum-dose romiplostim N01 withdraw.
* Romiplostim N01 Tapering Phase (Weeks 25-32) Patients with PLT ≥50×10⁹/L in the last two core phase visits discontinue orelabrutinib. Romiplostim N01 is tapered: doses \>3ug/Kg/week are reduced to 2-3ug/Kg/week, then dosing intervals extended (weekly→every 10 days→every 2 weeks). Patients with two consecutive PLT \<30×10⁹/L withdraw.
* Follow-up Phase (Weeks 33-56) Successfully tapered patients are followed up every 4 weeks to monitor PLT and adverse events (graded per NCI-CTC AE 5.0). Relevant events are reported to the sponsor's Pharmacovigilance Department.
Study:
NCT07400250
Study Brief:
Protocol Section:
NCT07400250