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

NCT04110275 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2019-10-11

No results posted yet for this study

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.

Conditions

  • Acute Pulmonary Embolism

Interventions

DRUG

Recombinant human tissue-type plasminogen activator derivative

Recombinant human tissue-type plasminogen activator derivative(rPA,chemical name: Reteplase,brand name:Ruitongli) 18mg/10ml/stick, provided by AngDe Biotech Pharmaceutical Co.,LIMITED(LTD)

DRUG

Recombinant human tissue-type plasminogen activator

Recombinant human tissue-type plasminogen activator(rt-PA,chemical name:Alteplase,brand name: Actilyse)50mg/stick,provided by Boehringer Ingelheim Pharma Gesellschaft mit beschrankter Haftung(GmbH)\&Co,

Sponsors & Collaborators

  • Angde Biotech Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • zhenguo Zhai, Doctor · China-Japan Friendship Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-31
Primary Completion
2021-05-31
Completion
2021-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04110275 on ClinicalTrials.gov