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NCT02093741
ADVATE 2 mL Post-Authorization Safety Surveillance (PASS)
trial testing Octocog alfa (recombinant human coagulation factor VIII) [ADVATE] in Hemophilia A in 65 participants. Completed in 20 January 2016.
20 January 2016
Quick facts
| Lead sponsor | Baxalta now part of Shire |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 65 |
| Start date | 20 September 2013 |
| Primary completion | 20 January 2016 |
| Estimated completion | 20 January 2016 |
| Sites | 17 locations across France, United Kingdom, Germany, Hungary |
Drugs / interventions tested
- Octocog alfa (recombinant human coagulation factor VIII) [ADVATE] — full drug profile →
Conditions studied
- Hemophilia A — all drugs for Hemophilia A →
- Congenital Factor VIII (FVIII) Deficiency — all drugs for Congenital Factor VIII (FVIII) Deficiency →
Sponsor
Baxalta now part of Shire — full company profile →
Who can join
Under 12, any sex, with Hemophilia A or Congenital Factor VIII (FVIII) Deficiency. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Post-Authorization Safety Surveillance (PASS) study designed to collect data on the safety and effectiveness of ADVATE reconstituted in 2 mL Sterile water for injection (SWFI) during routine clinical practice in children until 12 years of age. This surveillance study is a post-licensure commitment for ADVATE reconstituted in 2 mL SWFI.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Postauthorization safety surveillance study of antihaemophilic factor (recombinant) reconstituted in 2 mL sterile water for injection in children with haemophilia A.
Motwani J, Guillet B, Blatny J, Schilling FH, et al · · 2020 · cited 1× · PMID 32338433 · DOI 10.1111/hae.13997
Verify or expand the search:
- PubMed search for NCT02093741
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Octocog alfa (recombinant human coagulation factor VIII) [ADVATE]
Trials testing the same drug.
- NCT00916032 — Pharmacokinetic Study of ADVATE 3000 IU in Previously Treated Patients With Severe Hemophilia A · Phase 4 · completed
Other recruiting trials for Hemophilia A
Currently open trials in the same condition.
- NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
- NCT07416604 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A · Phase 3 · recruiting
- NCT07523399 — Joint Health, Balance and Quality of Life in Adults With Hemophilia A · recruiting
- NCT06833983 — To Evaluate the Clinical Study of GS1191-0445 Injection in the Treatment of Hemophilia A · Phase 3 · recruiting
- NCT06579144 — Pharmacokinetic Comparison of Efanesoctocog Alfa vs Other EHL-rFVIII Products in Participants With Severe Haemophilia A · Phase 1 · 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 NCT02093741 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 17 March 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/NCT02093741.
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