Phase II Study of Orelabrutinib in Combination With Romiplostim N01 in Patients With Primary Immune Thrombocytopenia (ITP) Who Have Received At Least One Prior Line of Therapy

What Was Tested

This registered phase 2 trial tested Romiplostim.

It had 1 arm (groups): Orelabrutinib combined with Romiplostim N01 (experimental).

The registry classes the interventions as drug.

More on the Plan

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.

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).

Who Took Part

28 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Subjects voluntarily participate in this study and provide written informed consent；. Age 18-80 years, inclusive, regardless of gender；. ECOG score 0 to 2；. Documented diagnosis of chronic primary Immune Thrombocytopenia (ITP) with a disease duration \>12 months；. A history of response to prior standard ITP therapy (defined as achieving a platelet count ≥50×10⁹/L)；.

The full record lists 8 inclusion and 14 exclusion criteria; among the exclusions: subjects suffer from severe itp at screening;; subjects have other diseases which mention in protocol;; subjects develop intracranial hemorrhage within 6 months prior to screening;.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Romiplostim study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2026-04-01 with completion listed for 2026-10-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 24-Week Sustained Platelet Response Rate (time frame: Up to 24 weeks).

It also tracked 11 secondary outcomes, for example The sustained remission off-treatment (SROT), The cumulative number of weeks of platelet response, The time to first achievement of a platelet count ≥ 50×10⁹/L, Cumulative response time, Complete response rate and Time to First Rescue Therapy(TFRT).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Romiplostim in 28 people.

Its size is small, so on its own it can only give an early look.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Romiplostim compound page, all human trials.