ArticleEJHaem2025
Multicenter Single-Blind Randomized Controlled Trial of the Romiplostim Biosimilar.
Article in EJHaem, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06497036 (Multicenter Randomized Controlled Study of Efficacy, Safety and Immunogenicity of GP40141), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Multicenter Randomized Controlled Study of Efficacy, Safety and Immunogenicity of GP40141 (GEROPHARM, Russia) Compared With Nplate® (Amgen, the Netherlands) in Patients With Persistent or Early Immune Thrombocytopenia
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: This was a randomized multicenter single-blinded active-controlled equivalence Phase III study evaluating the efficacy and safety of the biosimilar of romiplostim (GP40141) compared to the reference drug Nplate in patients with persistent or chronic immune thrombocytopenia (ITP). Methods: The study included 136 adult patients randomized 1:1 to receive either the biosimilar or reference drug for 26 weeks. The primary endpoint was the proportion of patients achieving a platelet response (≥ 50 × 10 Results: The proportion of patients with platelet response after 10 weeks of therapy was 78% in the test group and 85% in the comparison group. The absolute difference in proportion between groups was -0.06 (95% CI [-0.196, 0.068] and it falls within the equivalence limits [-0.225, 0.225]). The study demonstrated equivalence in the primary endpoint, with no significant differences between the biosimilar and reference drug groups in durable responses rate, bleeding events, or safety profiles. Conclusions: The results support the biosimilar romiplostim as an equivalent and comparable treatment option to the reference drug for patients with persistent or chronic ITP. Trial Registration: NCT06497036.
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Registered trials
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