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

Acute Pulmonary Embolism Clinical Trial

Official title:
A Phase II Clinical Study to Evaluate the Efficacy and Safety of Thrombolytic Therapy With Recombinant Human Tissue-type Plasminogen Activator Derivative for Acute Pulmonary Embolism

Clinical Trial 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.

Clinical Trial Description

This trial is a multicenter, randomized, open and parallel controlled project designed for patients with acute pulmonary embolism requiring thrombolysis after anticoagulant therapy in high-risk and middle-high risk populations.

For the first stage: Subjects who are qualified for the screening criteria according to the inclusion and exclusion criteria will be randomly assigned to low-dose test drugs, high-dose test drugs or reference drugs for thrombolytic therapy at a ratio of 1:1:1.

For the second stage: Subjects who are qualified for the screening criteria according to the inclusion and exclusion criteria will be randomly assigned to rPA(test group)or rt-PA(control group) for thrombolytic therapy at a ratio of 1:1. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04110275
Study type Interventional
Source Angde Biotech Pharmaceutical Co., Ltd.
Contact yongbiao xu, Manager
Phone 008615163577213
Email xuyongbiao2@crbiopharm.com
Status Not yet recruiting
Phase Phase 2
Start date October 2019
Completion date August 2021
View Details
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