drugset / Trial / NCT04110275

Injection of Recombinant Human Tissue-type Plasminogen Activator Derivative for Acute Pulmonary Embolism(rPA)

NCT04110275

Phase 2 Unknown 174 enrolled Angde Biotech Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this trial is to compare the efficacy and safety of Recombinant Human Tissue-Type Plasminogen Activator Derivative(rPA) and Recombinant Tissue-Type Plasminogen Activator(rt-PA) for the treatment of acute pulmonary embolism. This trial includes two stages, the first stage is to study the dosage of administration of the test drug(rPA), the second is to compare the efficacy and safety of rPA and rt-PA. Both of the two stages are randomized, open and parallel controlled.

Timeline

Start
2019-10
Primary completion
2021-05
Completion
2021-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Alteplase Protein / enzyme biologic 9 mg Intravenous
Subject reteplase Protein / enzyme biologic 18 mg Intravenous

Indications