N/A
Completed N=16
A Study of TAK-660 in Surgical Procedures for People With Hemophilia A.
Source: ClinicalTrials.gov NCT04941898 ↗Enrolled (actual)
16
Serious AEs
6.7%
Results posted
Nov 2024
Primary outcomePrimary: Number of Participants With Adverse Events — 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
2 | — |
| PRIMARY Number of Participants With Serious Adverse Events |
1 | — |
| PRIMARY Number of Participants With Adverse Drug Reaction |
— | — |
| PRIMARY Number of Participants With Serious Adverse Drug Reaction |
— | — |
| PRIMARY Number of Participants With Adverse Reactions Categorized as Inhibitor Development, Shock, or Anaphylaxis |
— | — |
| SECONDARY Intraoperative Hemostatic Efficacy of Recombinant FVIII PEGylated Intravenous Infusion |
93.3; 6.7; 0; 0 | — |
| SECONDARY Postoperative Hemostatic Efficacy of Recombinant FVIII PEGylated Intravenous Infusion 1 Day After Surgery |
56.3; 37.5; 6.3; 0 | — |
| SECONDARY Postoperative Hemostatic Efficacy of Recombinant FVIII PEGylated Intravenous Infusion at Completion of Perioperative Management |
50.0; 43.8; 6.3; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with blood coagulation factor VIII (FVIII) deficiency who received this drug during surgery or treatment after the start date of this survey.
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT04941898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.