A Study of Romiplostim N01 as the First-line Treatment for Newly Diagnosed Adult Patients With ITP

What Was Tested

The trial (phase 2) is built around Romiplostim.

The subjects will be divided into the experimental group and the control group for treatment.

It had two arms (groups): romiplostim combined with glucocorticoids (experimental) and glucocorticoids (active comparator).

The registry classes the interventions as drug.

More on the Plan

This study is a multicenter interventional research, and it is planned to incorporate 129 newly diagnosed adult ITP patients who have not undergone treatment.

For patients meeting the inclusion criteria, after signing the informed consent and passing the screening, they will be randomly grouped.

Screening period: Assess the inclusion and exclusion criteria.

Those who fulfill the conditions can enter the treatment period.

Who Took Part

129 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Sign the written informed consent form before enrollment;. Age ranging from 18 to 75 years old;. Be clinically diagnosed with primary immune thrombocytopenia for less than 3 months before randomization;. Have not received romiplostim treatment;. ECOG PS score: 0 - 2;.

The full record lists 10 inclusion and 17 exclusion criteria; among the exclusions: being pregnant or lactating, or having a pregnancy plan;; having fertility and being judged by the researcher as not fully adopting contraceptive measures;; having a history of severe drug allergic reactions or being known to be allergic to glucocorticoids or nplate® (romiplostim) or the components of ql0911;.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Romiplostim study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Romiplostim group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Romiplostim study: the participants and staff both knew the treatment.

It started in 2024-06-01 with completion listed for 2025-06-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The proportion of patients with continuous remission (time frame: 6 months).

It also tracked 8 secondary outcomes, for example The maximum consecutive weeks of platelet response, The proportion of subjects receiving rescue treatment, According to the WHO bleeding score standard, the incidence and severity of bleeding symptoms and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Romiplostim in 129 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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