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A Study to Evaluate the Pharmacokinetics of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection

NCT03747653 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2020-05-08

No results posted yet for this study

Summary

Primary objective: To assess the pharmacokinetics of Recombinant Human Coagulation Factor VIII-Fc fusion protein for Injection at two dose levels in patients with hemophilia A.

Secondary objectives: To assess Safety and Tolerability by monitoring FVIII recovery and adverse events in patients with hemophilia A.

Conditions

Interventions

DRUG

ADVATE

Patients will be administered a single dose of ADVATE.

DRUG

FRSW107

Patients will be administered a single dose of FRSW107 for Injection.

Sponsors & Collaborators

  • Beijing Furen Biomedical Research Institute Co., Ltd.

    collaborator UNKNOWN

  • Kaifeng Pharmaceutical (Group) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Renchi Yang, PhD · Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College

Eligibility

Min Age
12 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-08
Primary Completion
2020-05-31
Completion
2020-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT03747653 on ClinicalTrials.gov