Hemophilia ANCT04941898

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

An observational study of Hemophilia A, run by Takeda at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Hemophilia A
What is being tested?: PEGylated Recombinant Factor VIII
Type of treatment: Injection or infusion
How many people: 16 participants
Where: 1 siteJapan
Study dates: 30 Jun 2021to 15 Mar 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

Japan1 site

Takeda Selected Site
Tokyo

Other trials in Japan

About this study

Official title: Adynovate Special Drug Use Result Survey (Perioperative Administration)

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
Being tested: PEGylated Recombinant Factor VIII
Medical subject headings: Hemophilia A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PEGylated Recombinant Factor VIIIBiological
Also called TAK-660, BAX855, ADYNOVATE
Polyethylene glycol (PEG)-ylated full-length recombinant FVIII (rFVIII)

Study groups in NCT04941898
Study group	Role	What they receive
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. Receives: Biological: PEGylated Recombinant Factor VIII

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 30 Days

Secondary outcomes (3)

Intraoperative Hemostatic Efficacy of Recombinant FVIII PEGylated Intravenous Infusion
The number of surgeries with each rating on hemostatic efficacy was counted and the percentage was reported. Intraoperative hemostatic efficacy was assessed by following four rating and criteria. Excellent: Intraoperative blood loss was less than or equal to that expected for the type of procedure performed in a non-hemophilic population (≤100%)), Good: Intraoperative blood loss was up to 50% more than expected for the type: of procedure performed in a non-hemophilic population (101-150%), Fair: Intraoperative blood loss was more than 50% of that expected for the type of procedure performed in a non-hemophilic population (>150%) None: Uncontrolled hemorrhage that was the result of inadequate therapeutic response despite proper dosing, necessitating rescue therapy with study drug or other replacement therapy.
Measured: Day 1 (date of surgery)
Postoperative Hemostatic Efficacy of Recombinant FVIII PEGylated Intravenous Infusion 1 Day After Surgery
The number of surgeries with each rating on hemostatic efficacy was counted and the percentage was reported. Postoperative hemostatic efficacy 1 day after surgery was assessed by following four rating and criteria. Excellent: Postoperative hemostasis achieved with study drug was as good or better than that expected for the type of surgical procedure performed in a nonhemophilic population, Good: Postoperative hemostasis achieved with study drug was probably as good as that expected for the type of surgical procedure performed in a nonhemophilic population, Fair: Postoperative hemostasis with study drug was clearly less than optimal for the type of procedure performed but was maintained without necessitating rescue therapy with study drug or other replacement therapy, None: Participant experienced uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating rescue therapy with study drug or other replacement therapy.
Measured: 1 Day post-surgery
Postoperative Hemostatic Efficacy of Recombinant FVIII PEGylated Intravenous Infusion at Completion of Perioperative Management
Postoperative hemostatic efficacy at completion of perioperative management was assessed by following four rating and criteria. Excellent: Postoperative hemostasis achieved after Day 1 with study drug was as good or better than that expected for the type of surgical procedure performed in a non-hemophilic population, Good: Postoperative hemostasis achieved after Day 1 with study drug was probably as good as that expected for the type of surgical procedure performed in a non-hemophilic population, Fair: Postoperative hemostasis with study drug after Day 1 was clearly less than optimal for the type of procedure performed but was maintained without necessitating rescue therapy with study drug or other replacement therapy, None: Participant experienced uncontrolled bleeding after Day 1 that was the result of inadequate therapeutic response despite proper dosing, necessitating rescue therapy with study drug or other replacement therapy.
Measured: At completion of perioperative management (approximately 30 days after surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 202115 Mar 2024

First posted28 Jun 2021
Study start30 Jun 2021
Primary completion15 Mar 2024
Study completion15 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hemophilia AStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04941898
Sponsor's protocol ID: TAK-660-5002
Other IDs: jRCT2031210173
Status last verified: Sep 2024
First submitted: 25 Jun 2021
Last updated: 15 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B

All Hemophilia A trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adynovate Special Drug Use Result Survey (Perioperative Administration)
ClinicalTrials.gov ID: NCT04941898
Acronym / sponsor ID: TAK-660-5002
Conditions: Hemophilia A
Study type: Observational
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 30 Jun 2021 (actual)
Primary completion: 15 Mar 2024 (actual)
Study completion: 15 Mar 2024 (actual)
First posted: 28 Jun 2021 (actual)
Results: Posted 15 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
TAK-660 15-50 international units per kilograms (IU/kg)	–	Biological: PEGylated Recombinant Factor VIIIParticipants will receive TAK-660 15-50 IU/kg slow intravenous injection every 8- 24 hours until the bleeding is resolved or wound healing.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PEGylated Recombinant Factor VIIIAlso: TAK-660, BAX855, ADYNOVATEPolyethylene glycol (PEG)-ylated full-length recombinant FVIII (rFVIII)	Biological	TAK-660 15-50 international units per kilograms (IU/kg)

Primary outcome

Number of Participants With Adverse Events
Time frame: Up to 30 Days
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.
Number of Participants With Serious Adverse Events
Time frame: Up to 30 Days
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.
Number of Participants With Adverse Drug Reaction
Time frame: Up to 30 Days
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.
Number of Participants With Serious Adverse Drug Reaction
Time frame: Up to 30 Days
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.
Number of Participants With Adverse Reactions Categorized as Inhibitor Development, Shock, or Anaphylaxis
Time frame: Up to 30 Days
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.

3 secondary outcomes

Intraoperative Hemostatic Efficacy of Recombinant FVIII PEGylated Intravenous Infusion
Time frame: Day 1 (date of surgery)
Postoperative Hemostatic Efficacy of Recombinant FVIII PEGylated Intravenous Infusion 1 Day After Surgery
Time frame: 1 Day post-surgery
Postoperative Hemostatic Efficacy of Recombinant FVIII PEGylated Intravenous Infusion at Completion of Perioperative Management
Time frame: At completion of perioperative management (approximately 30 days after surgery)

Results and safety

Results posted to the registry on 15 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Recombinant FVIII PEGylated Intravenous Infusion	16	15

Primary outcome: Number of Participants With Adverse Events

Time frame: Up to 30 Days. Count of participants. Unit: Participants

Measure	Recombinant FVIII PEGylated Intravenous Infusion n = 15
Value	2

Population analysed: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

Primary outcome: Number of Participants With Serious Adverse Events

Time frame: Up to 30 Days. Count of participants. Unit: Participants

Measure	Recombinant FVIII PEGylated Intravenous Infusion n = 15
Value	1

Population analysed: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

Primary outcome: Number of Participants With Adverse Drug Reaction

Time frame: Up to 30 Days. Count of participants. Unit: Participants

Measure	Recombinant FVIII PEGylated Intravenous Infusion n = 15
Value	0

Population analysed: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

Primary outcome: Number of Participants With Serious Adverse Drug Reaction

Time frame: Up to 30 Days. Count of participants. Unit: Participants

Measure	Recombinant FVIII PEGylated Intravenous Infusion n = 15
Value	0

Population analysed: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Recombinant FVIII PEGylated Intravenous Infusion	1 of 15 (6.7%)	1 of 15 (6.7%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain more information on the study, click here/on this linkLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Related trials for Hemophilia A

RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hemophilia A, run by Takeda at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (time frame: Up to 30 Days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04941898.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.