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

NCT04941898 | Completed Results

• 2 other identifiers: TAK-660-5002jRCT2031210173
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Hemophilia A

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Adverse Events

  An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

  Up to 30 Days

• Number of Participants With Serious Adverse Events

  A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.

  Up to 30 Days

• Number of Participants With Adverse Drug Reaction

  An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. Adverse drug reaction refers to AE related to administered drug.

  Up to 30 Days

• Number of Participants With Serious Adverse Drug Reaction

  A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Adverse drug reaction refers to AE related to administered drug.

  Up to 30 Days

• Number of Participants With Adverse Reactions Categorized as Inhibitor Development, Shock, or Anaphylaxis

  An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. Number of participants with adverse reactions categorized as inhibitor development, shock, or anaphylaxis was reported.

  Up to 30 Days

Secondary Outcomes (3)

• Intraoperative Hemostatic Efficacy of Recombinant FVIII PEGylated Intravenous Infusion

  Day 1 (date of surgery)

• Postoperative Hemostatic Efficacy of Recombinant FVIII PEGylated Intravenous Infusion 1 Day After Surgery

  1 Day post-surgery

• Postoperative Hemostatic Efficacy of Recombinant FVIII PEGylated Intravenous Infusion at Completion of Perioperative Management

  At completion of perioperative management (approximately 30 days after surgery)

Study Arms (1)

TAK-660 15-50 international units per kilograms (IU/kg)

Participants will receive TAK-660 15-50 IU/kg slow intravenous injection every 8- 24 hours until the bleeding is resolved or wound healing.

Biological: PEGylated Recombinant Factor VIII

Interventions

PEGylated Recombinant Factor VIII BIOLOGICAL

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

Also known as: TAK-660, BAX855, ADYNOVATE

TAK-660 15-50 international units per kilograms (IU/kg)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with blood coagulation factor VIII (FVIII) deficiency who received this drug during surgery or treatment after the start date of this survey.

You may qualify if:

• Participants with blood coagulation factor VIII (FVIII) deficiency who received this drug during surgery or treatment after the start date of this survey.

You may not qualify if:

• None

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Takeda Selected Site

Tokyo, Japan

Location

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Conditions

Hemophilia A

Interventions

BAX 855

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: June 28, 2021
• Study Start: June 30, 2021
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: November 15, 2024
• Results First Posted: November 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)