CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 16 enrolled
Drug / intervention
PEGylated Recombinant Factor VIIIbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04941898
NCT04941898N/ACompleted

Adynovate Special Drug Use Result Survey (Perioperative Administration)

Takeda·observational·Posted Jun 28, 2021·Updated Nov 15, 2024

In Brief

An observational study evaluating PEGylated Recombinant Factor VIII for Hemophilia A. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesJapan
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJun 28, 2021
Enrollment StartJun 30, 2021
Primary CompletionMar 15, 2024
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 5.0 years ago

Interventions

PEGylated Recombinant Factor VIIIbiological

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