Comparative Study of Clinical Efficacy and Safety of GNR-069 and Nplate in Patients With ITP

What Was Tested

The trial (phase 3) is built around Romiplostim.

It had two arms (groups): GNR-069 (experimental) and Nplate (active comparator).

The registry classes the interventions as biological.

Who Took Part

160 actual participants took part.

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: Written Informed Consent Form to participate in the study;. Men and women aged 18-75 years inclusive at the time of signing the Informed Consent Form;. Documented diagnosis of ITP with a disease duration of more than 12 months from the moment of confirmation of the diagnosis by bone marrow aspirate or biopsy results;. A. For patients who have not had splenectomy:. Established absence/loss of response to therapy with at least one drug of fist-line treatment for ITP (which include GCs an IVIG); OR.

The full record lists 9 inclusion and 21 exclusion criteria; among the exclusions: hypersensitivity to the components of investigational or reference drug or e. coli proteins ;; unresolved severe hemorrhagic syndrome requiring emergency treatment at the time of initiation of study or reference drug therapy ;; fisher-evans syndrome;.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Romiplostim and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Romiplostim study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2021-09-09 with completion listed for 2023-08-22.

It ran at 18 sites in Russia (18).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Proportion of patients achieving sustained response to treatment (time frame: 26 weeks).

It also tracked 7 secondary outcomes, for example Proportion of patients who achieve stable platelet count during treatment with investigational or reference drug, Time from initiation of therapy with investigational or reference drug to reaching a stable platelet count, Change in ITP-specific bleeding assessment tool (ITP-BAT) scores at last visit from baseline at screening and Proportion of patients with no/loss of response to treatment with investigational or reference drug.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Romiplostim in 160 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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