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Study of Recombinant Human Coagulation Factor VIIa for Injection (FⅦa) in Patients With Hemophilia.

NCT04768699 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-02-24

No results posted yet for this study

Summary

Aim of this trial is to assess the pharmacokinetics and pharmacodynamics (PK/PD) of recombinant human coagulation factor VIIa for injection (FⅦa) in patients with hemophilia.

Conditions

  • Hemophilia A With Inhibitor
  • Hemophilia B With Inhibitor

Interventions

DRUG

TQG203

TQG203,30µg/kg body weight, will be administered as intravenous (i.v.) administration over a period about 2minutes (min) on Study Day 1 once.

DRUG

TQG203/NovoSeven®

In each of the two study periods (separated by a washout about two days),a single dose of TQG203 or NovoSeven® will be administered.TQG203 or NovoSeven®,90µg/kg body weight, will be administered as intravenous (i.v.) administration over a period about 2minutes (min) on Study Day 1.

DRUG

TQG203

TQG203,180µg/kg body weight, will be administered as intravenous (i.v.) administration over a period about 2minutes (min) on Study Day 1 once.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2021-12-01
Completion
2021-12-01

Countries

  • China

Study Locations

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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 NCT04768699 on ClinicalTrials.gov