A Study of Prometic Plasminogen IV Infusion in Subjects With Hypoplasminogenemia

Summary

This is a Phase 2/3 pivotal study to evaluate pharmacokinetics (PK), efficacy, and safety of Prometic Plasminogen (Human) Intravenous Lyophilized Solution, the investigational medicinal product (IMP), in pediatric and adult subjects with hypoplasminogenemia.

Timeline

Start

2016-05-04

Primary completion

2017-12-17

Completion

2018-10-08

Outcome

Met primary endpoint

paper The primary efficacy endpoint was achieved, as 100% of subjects (n = 11) with visible and assessable non-visible lesions at baseline demonstrated ≥ 50% improvement after 48 weeks PMID 37674358 ↗

paper All subjects achieved the targeted ≥ 10% increase in trough plasminogen activity above baseline through Week 12. PMID 37674358 ↗

Publications

• Background Shapiro AD, Nakar C, Parker JM, Albert GR, Moran JE, Thibaudeau K, Thukral N, Hardesty BM, Laurin P, Sandset PM. Plasminogen replacement therapy for the treatment of children and adults with congenital plasminogen deficiency. Blood. 2018 Mar 22;131(12):1301-1310. doi: 10.1182/blood-2017-09-806729. Epub 2018 Jan 10.
• Shapiro AD, Nakar C, Parker JM, Thibaudeau K, Crea R, Sandset PM. Plain language summary: a phase 2/3 study of plasminogen, human-tvmh for the treatment of children and adults with type 1 plasminogen deficiency. Expert Rev Hematol. 2026 Jul;19(7):669-680. doi: 10.1080/17474086.2026.2678346. Epub 2026 Jun 1.
• Shapiro AD, Nakar C, Parker JM, Thibaudeau K, Crea R, Sandset PM. Plasminogen, human-tvmh for the treatment of children and adults with plasminogen deficiency type 1. Haemophilia. 2023 Nov;29(6):1556-1564. doi: 10.1111/hae.14849. Epub 2023 Sep 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Plasminogen	Unknown	6.6 mg/kg	Intravenous

Indications