Atorvastatin Combined With NAC Plus Romiplostim for Management of ITP

What Was Tested

This registered not phased trial tested Romiplostim.

This is a prospective, single-arm, open-lable, single-center study and the researchers aimed to determine whether atorvastatin combined with N-acetyl-L-cysteine (NAC) plus romiplostim could induce sustained response off-treatment (SRoT) in adult patients with ITP following CS failure.

It had 1 arm (groups): combined therapy (experimental).

The registry classes the interventions as drug.

More on the Plan

This is a prospective, single-arm trial designed to investigate whether atorvastatin combined with N-acetyl-L-cysteine (NAC) plus romiplostim can induce a sustained response off-treatment (SRoT) in adult patients with immune thrombocytopenia (ITP) who experienced failure of first-line corticosteroid therapy.

In this study, SRoT is defined as an off-treatment period during which the platelet count remains above 30×10⁹/L in the absence of bleeding events or rescue therapy.

The primary endpoint was the proportion of patients who achieved SRoT by Week 24 after the discontinuation of romiplostim.

From Week 25 to Week 35, romiplostim was gradually tapered and discontinued, with the goal of maintaining a platelet count ≥30×10⁹/L and no less than twice the baseline level.

Who Took Part

The registry lists 50 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Diagnosed with primary ITP;. Aged ≥18 years;. Patients with treatment failure or relapse after first-line corticosteriod therapy for ITP;. Platelet count \<30×10⁹/L.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: pregnant or lactating women, and who were possibly pregnant, planning to become pregnant, or who had partners planning to become pregnant;; presence of active malignant tumors;; active hbv, hcv or hiv infection;.

How the Study Was Run

It was run as a single-group and open-label study.

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

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

It started in 2026-06-01 with completion listed for 2027-12-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 24-week SRoT rate (time frame: 24 weeks post-treatment cessation).

It also tracked 7 secondary outcomes, for example 24-week SCRoT rate, ORR, CR rate, TTR, Sustained response and Bleeding events.

What This Means in Plain Language

Put simply, this is a not phased trial of Romiplostim in 50 people.

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.