Protein C DeficiencyNCT06590974
A Study of Freeze-dried Human Protein C Concentrate (TAK-662) in Participants With Congenital Protein C Deficiency
An observational study of Protein C Deficiency, run by Takeda at 1 site in Japan.
Trial summary
This study is conducted in Japan of Freeze-dried Human Protein C Concentrate (TAK-662) used to treat participants with congenital protein C deficiency. The main aim of the study is to evaluate for adverse events and effectiveness of congenital protein C deficiency (TAK-662). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Protein C Deficiency
- What is being tested?
- Freeze-dried Human Protein C Concentrate
- Type of treatment
- Injection or infusion
- How many people
- 7 participants
- Where
- 1 siteJapan
- Study dates
- 6 Sep 2024to 30 Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The population of this study are all participants who meet the inclusion/exclusion criteria.
Who may be able to join
- All participants with congenital protein C deficiency who are administered with Freeze-dried Human Protein C Concentrate (TAK-662).
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Special Drug Use Surveillance Study of Ceprotin for Intravenous Injection 1000IU (All-Case Surveillance)
This study is conducted in Japan of Freeze-dried Human Protein C Concentrate (TAK-662) used to treat participants with congenital protein C deficiency.
The main aim of the study is to evaluate for adverse events and effectiveness of congenital protein C deficiency (TAK-662).
During the study, participants with congenital protein C deficiency will be administered with TAK-662 intravenous injection in under routine normal practice. The investigators will evaluate adverse events due to TAK-662 for 12 months. For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, the investigator will evaluate for 24 months as a maximum. The study sponsor will not be involved in how the participants are administered but will be recorded what happens during the study.
- Conditions
- Protein C Deficiency
- Being tested
- Freeze-dried Human Protein C Concentrate
- Keywords
- Ceprotin/Protein C Deficiency
- Medical subject headings
- Protein C Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze-dried Human Protein C ConcentrateDrug
Freeze-dried Human Protein C Concentrate (TAK-662) intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| Freeze-dried Human Protein C Concentrate (TAK-662) | Participants will be administered Freeze-dried Human Protein C Concentrate (TAK-662) intravenous injection. Receives: Drug: Freeze-dried Human Protein C Concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE)
Measured: Up to 12 months (For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, up to 24 months as a maximum)
Secondary outcomes (2)
Number of Participants who Experience at Least One TEAE of Venous Thromboembolism
Measured: Up to 12 months (For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, up to 24 months as a maximum)
Number of Participants who Experience at Least One TEAE of Purpura Fulminans
Measured: Up to 12 months (For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, up to 24 months as a maximum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start6 Sep 2024
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein C DeficiencyStudies 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
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590974
- Sponsor's protocol ID
- TAK-662-4002
- Other IDs
- jRCT2031240322
- Status last verified
- Jul 2026
- First submitted
- 5 Sep 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites).
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Surveillance Study of Ceprotin for Intravenous Injection 1000IU (All-Case Surveillance)
- ClinicalTrials.gov ID
- NCT06590974
- Acronym / sponsor ID
- TAK-662-4002
- Conditions
- Protein C Deficiency
- Keywords
- Ceprotin/Protein C Deficiency
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2024 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
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 conducted in Japan of Freeze-dried Human Protein C Concentrate (TAK-662) used to treat participants with congenital protein C deficiency.
The main aim of the study is to evaluate for adverse events and effectiveness of congenital protein C deficiency (TAK-662).
During the study, participants with congenital protein C deficiency will be administered with TAK-662 intravenous injection in under routine normal practice. The investigators will evaluate adverse events due to TAK-662 for 12 months. For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, the investigator will evaluate for 24 months as a maximum. The study sponsor will not be involved in how the participants are administered but will be recorded what happens during the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Freeze-dried Human Protein C Concentrate (TAK-662) | – | Drug: Freeze-dried Human Protein C ConcentrateParticipants will be administered Freeze-dried Human Protein C Concentrate (TAK-662) intravenous injection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population of this study are all participants who meet the inclusion/exclusion criteria.
Key inclusion criteria (1 listed)
- All participants with congenital protein C deficiency who are administered with Freeze-dried Human Protein C Concentrate (TAK-662).
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 |
|---|---|---|
| Freeze-dried Human Protein C ConcentrateFreeze-dried Human Protein C Concentrate (TAK-662) intravenous injection | Drug | Freeze-dried Human Protein C Concentrate (TAK-662) |
Primary outcome
Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE)
Time frame: Up to 12 months (For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, up to 24 months as a maximum)
2 secondary outcomes
Number of Participants who Experience at Least One TEAE of Venous Thromboembolism
Time frame: Up to 12 months (For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, up to 24 months as a maximum)
Number of Participants who Experience at Least One TEAE of Purpura Fulminans
Time frame: Up to 12 months (For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, up to 24 months as a maximum)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Click here for more information about this trial in easy-tounderstand language, including a Plain Language Summary of the results if the trial has been completed.Link provided by the sponsor.
- Individual participant dataSharing planned: No. De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites).
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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.
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 Protein C Deficiency, 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: looking for participants now, as of the sponsor's last update on 31 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE) (time frame: Up to 12 months (For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, up to 24 months as a maximum)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2026.