CompletedPhase 1/2

A Study of TAK-662 for Japanese Patients With Congenital Protein C Deficiency

Japan5 participantsStarted 2021-09-07

Plain-language summary

Pharmacokinetic Part: This study is for Japanese participants with congenital protein C deficiency. The main aim of this study is to check how much TAK-662 stays in their blood over time. This will help the study sponsor (Takeda) to work out the best dose to give patients in the future. Participants will receive 1 single infusion of TAK-662. They will stay at the clinic until 3 days after the infusion. Then, participants will return to their clinic 7 days after the infusion to check side effects from the study treatment. Extension Part: Participants who will complete the PK part will be given an opportunity to continue TAK-662 administration as 3 different treatment options (on-demand therapy, short-term prophylaxis, and long-term prophylaxis) in the Extension part, until the commercial protein C concentrate is available at each study site or study termination.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male and female participants with Japanese nationality.
. A diagnosis of congenital protein C deficiency (homozygous or compound heterozygous).
. Asymptomatic participant.
. Oral anticoagulants allowed to be received.
. Participants who participated in the PK part of this study (TAK-662-1501).
. Participant who are; a. Diagnosed with PF, CISN/WISN, and/or other acute thromboembolic episode for on-demand treatment only; b. Requiring treatment with TAK-662 for short-term prophylaxis for surgical procedures; c. Requiring treatment with TAK-662 for long-term prophylaxis.

Exclusion criteria

. Current or recurrent disease that could affect the action, or disposition of the investigational product (IP), or clinical or laboratory assessments.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PK Part: Protein C Activity Level of TAK-662

Timeframe: Pre-infusion, 0.5, 1, 2, 4, 8, 12, 24, and 36 hours post-infusion

PK Part: Terminal Phase Elimination Half-life (t1/2) of TAK-662

Timeframe: Pre-infusion, 0.5, 1, 2, 4, 8, 12, 24, and 36 hours post-infusion

PK Part: Incremental Recovery (IR) of TAK-662

Timeframe: Pre-infusion, 0.5, 1, 2, 4, 8, 12, 24, and 36 hours post-infusion

PK Part: Percentage of In-vivo Recovery (IVR) of TAK-662

Timeframe: Pre-infusion, 0.5, 1, 2, 4, 8, 12, 24, and 36 hours post-infusion

PK Part: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of TAK-662

Timeframe: Pre-infusion, 0.5, 1, 2, 4, 8, 12, 24, and 36 hours post-infusion

PK Part: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-infinity) of TAK-662

Timeframe: Pre-infusion, 0.5, 1, 2, 4, 8, 12, 24, and 36 hours post-infusion

Trial details

NCT IDNCT04984889

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-03-29

Results submitted2023-03-27

View on ClinicalTrials.gov More Congenital Protein C Deficiency trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male and female participants with Japanese nationality.
. A diagnosis of congenital protein C deficiency (homozygous or compound heterozygous).
. Asymptomatic participant.
. Oral anticoagulants allowed to be received.
. Participants who participated in the PK part of this study (TAK-662-1501).
. Participant who are; a. Diagnosed with PF, CISN/WISN, and/or other acute thromboembolic episode for on-demand treatment only; b. Requiring treatment with TAK-662 for short-term prophylaxis for surgical procedures; c. Requiring treatment with TAK-662 for long-term prophylaxis.

Exclusion criteria

. Current or recurrent disease that could affect the action, or disposition of the investigational product (IP), or clinical or laboratory assessments.

What they're measuring

PK Part: Protein C Activity Level of TAK-662

Timeframe: Pre-infusion, 0.5, 1, 2, 4, 8, 12, 24, and 36 hours post-infusion

PK Part: Terminal Phase Elimination Half-life (t1/2) of TAK-662

Timeframe: Pre-infusion, 0.5, 1, 2, 4, 8, 12, 24, and 36 hours post-infusion

PK Part: Incremental Recovery (IR) of TAK-662

Timeframe: Pre-infusion, 0.5, 1, 2, 4, 8, 12, 24, and 36 hours post-infusion

PK Part: Percentage of In-vivo Recovery (IVR) of TAK-662

Timeframe: Pre-infusion, 0.5, 1, 2, 4, 8, 12, 24, and 36 hours post-infusion

PK Part: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of TAK-662

Timeframe: Pre-infusion, 0.5, 1, 2, 4, 8, 12, 24, and 36 hours post-infusion

PK Part: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-infinity) of TAK-662

Timeframe: Pre-infusion, 0.5, 1, 2, 4, 8, 12, 24, and 36 hours post-infusion