Evaluating a new treatment for congenital protein C deficiency
Special Drug Use Surveillance Study of Ceprotin for Intravenous Injection 1000IU (All-Case Surveillance)
This study is testing a new treatment using a special protein to see if it helps people with congenital protein C deficiency feel better and stay safe over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 7 (estimated) |
| Sex | All |
| Sponsor | Takeda Industry-sponsored |
| Locations | 1 site (Tokyo, Tokyo) |
| Trial ID | NCT06590974 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the use of Freeze-dried Human Protein C Concentrate (TAK-662) to treat individuals with congenital protein C deficiency. Participants will receive intravenous injections of TAK-662 under routine clinical practice, and the study will monitor for any adverse events and the treatment's effectiveness over a period of up to 24 months. The study is conducted in Japan and aims to gather data on the safety and efficacy of this treatment in real-world settings.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with congenital protein C deficiency who are receiving TAK-662.
Not a fit: Patients who do not have congenital protein C deficiency will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve the management and outcomes for patients with congenital protein C deficiency.
How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in treating protein C deficiency with other therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- All participants with congenital protein C deficiency who are administered with Freeze-dried Human Protein C Concentrate (TAK-662). Exclusion Criteria: \- None
Where this trial is running
Tokyo, Tokyo
- Takeda selected site — Tokyo, Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.