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NCT02634723
Retrospective Chart Review to Evaluate Safety and Tolerability of ADVATE Among Previously Untreated Patients in China With Moderate to Severe Hemophilia A
trial testing Octocog alfa (recombinant human coagulation factor VIII) in Hemophilia A in 21 participants. Completed in 30 June 2016.
30 June 2016
Quick facts
| Lead sponsor | Baxalta now part of Shire |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 21 |
| Start date | 23 December 2015 |
| Primary completion | 30 June 2016 |
| Estimated completion | 30 June 2016 |
| Sites | 6 locations across China |
Drugs / interventions tested
- Octocog alfa (recombinant human coagulation factor VIII) — full drug profile →
Conditions studied
- Hemophilia A — all drugs for Hemophilia A →
Sponsor
Baxalta now part of Shire — full company profile →
Who can join
Eligibility, any sex, with Hemophilia A. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this post-marketing safety study is to evaluate the safety, immunogenicity, and effectiveness of ADVATE in previously untreated patients (PUPs) in China with moderate to severe hemophilia A.
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 NCT02634723
- 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)
Trials testing the same drug.
- NCT02170402 — China ADVATE PTP Study · 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 NCT02634723 (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: 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/NCT02634723.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing