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A Pharmacokinetic and Clotting Activity Study of FVIII-PEGLip

NCT04592692 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-10-21

No results posted yet for this study

Summary

The purpose of this study is to demonstrate that PEGylated liposomes (PEGLip) can shield FVIII from the immune system and inhibitors, and therefore provide a prophylactic FVIII replacement therapy for patients with inhibitors to FVIII.

Conditions

  • Hemophilia A With Inhibitor

Interventions

DRUG

PEGylated Liposome (PEGLip)

Intravenous co-administration of PEGLip with Simoctocog alfa

Sponsors & Collaborators

  • Ascension Healthcare Development Limited

    lead INDUSTRY

Principal Investigators

  • Sam Yurdakul · Ascension Healthcare

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-12-23
Primary Completion
2022-02-28
Completion
2022-05-31

Countries

  • Russia

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 NCT04592692 on ClinicalTrials.gov