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A Study of TAK-660 in Surgical Procedures for People With Hemophilia A.

NCT04941898 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2024-11-15

Study results available
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Summary

This study is about a factor VIII medicine called Adynovate (TAK-660) used during surgery for people with hemophilia A who have low blood levels of factor VIII.

The aims of this study are as follows:

* To check for side effects from TAK-660.
* To check how well TAK-660 controls bleeding when used routinely during surgery and other invasive procedures such as tooth extractions.

The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

During the study, participants will receive infusions of TAK-660 during their hospital stay for surgery according to their clinic's standard practice. The study doctors will check for bleeds and side effects from TAK-660 from surgery until discharge.

Conditions

Interventions

BIOLOGICAL

PEGylated Recombinant Factor VIII

Polyethylene glycol (PEG)-ylated full-length recombinant FVIII (rFVIII)

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2024-03-15
Completion
2024-03-15

Countries

  • Japan

Study Locations

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Entities

Diseases
Companies

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 NCT04941898 on ClinicalTrials.gov