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NCT00161720
Retrospective Study to Capture Dosing and Treatment Outcome Data in Participants With Severe Congenital Protein C Deficiency Who Were Treated With Protein C Concentrate Under an Emergency Use IND
trial testing Protein C Concentrate (Human) Vapor Heated in Protein C Deficiency in 11 participants. Completed in 1 December 2005.
1 December 2005
Quick facts
| Lead sponsor | Baxalta now part of Shire |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 11 |
| Start date | 1 June 2005 |
| Primary completion | 1 December 2005 |
| Estimated completion | 1 December 2005 |
| Sites | 10 locations across United States |
Drugs / interventions tested
- Protein C Concentrate (Human) Vapor Heated — full drug profile →
Conditions studied
- Protein C Deficiency — all drugs for Protein C Deficiency →
Sponsor
Baxalta now part of Shire — full company profile →
Who can join
Eligibility, any sex, with Protein C Deficiency. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a data collection study with the purpose of capturing dosing and treatment outcome data in participants with severe congenital protein C deficiency who were treated with protein C concentrate under an Emergency Use Investigational New Drug Application (IND).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00161720
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Protein C Concentrate (Human) Vapor Heated
Trials testing the same drug.
- NCT00157118 — Efficacy and Safety Study of Protein C Concentrate in Subjects With Severe Congenital Protein C Deficiency · Phase 2, PHASE3 · completed
Other recruiting trials for Protein C Deficiency
Currently open trials in the same condition.
- NCT06590974 — A Study of Freeze-dried Human Protein C Concentrate (TAK-662) in Participants With Congenital Protein C Deficiency · recruiting
Other Baxalta now part of Shire trials
Trials by the same sponsor.
- NCT04985682 — A Study of ADVATE in People With Hemophilia A in India · Phase 4 · completed
- NCT04578535 — A Study to Assess the Tolerability, Safety, and Pharmacokinetics of Subcutaneous Immune Globulin Infusion 10% (Human) Wi · Phase 1 · completed
- NCT04346108 — A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunode · Phase 3 · completed
- NCT04158934 — A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A · active not recruiting
- NCT04394286 — A Phase 1/2 Study of SHP648, an Adeno-Associated Viral Vector for Gene Transfer in Hemophilia B Subjects · Phase 1, PHASE2 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00161720 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Baxalta now part of Shire
- Last refreshed: 8 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00161720.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing