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NCT04789954
Study on the Dose-response Relationship of Pharmacodynamic Parameters in Patients With Hemophilia With Inhibitors
EARLY_PHASE1 trial testing Eptacog alfa, activated in Hemophilia A With Inhibitor in 14 participants. Completed in 31 July 2022.
13 August 2021
Quick facts
| Lead sponsor | AryoGen Pharmed Co. |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 14 |
| Start date | 29 December 2020 |
| Primary completion | 13 August 2021 |
| Estimated completion | 31 July 2022 |
| Sites | 1 location across Iran |
Drugs / interventions tested
- Eptacog alfa, activated
Conditions studied
- Hemophilia A With Inhibitor — all drugs for Hemophilia A With Inhibitor →
- Hemophilia B With Inhibitor — all drugs for Hemophilia B With Inhibitor →
Sponsor
AryoGen Pharmed Co. — full company profile →
Who can join
12 and older, male only, with Hemophilia A With Inhibitor or Hemophilia B With Inhibitor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Randomized, double-blind, single-dose, 5 ways crossover, exploratory clinical trial evaluating four different doses of AryoSeven (eptacog alfa, activated) and NovoSeven on selected pharmacodynamic parameters in patients with hemophilia with inhibitors.
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 NCT04789954
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hemophilia A With Inhibitor
Currently open trials in the same condition.
- NCT06312475 — Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B With Inhibitors · Phase 3 · active not recruiting
- NCT05888870 — ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor · Phase 4 · recruiting
- NCT04647227 — SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors · Phase 4 · recruiting
Other AryoGen Pharmed Co. trials
Trials by the same sponsor.
- NCT06137092 — rFVIII-Fc (Produced by AryoGen Pharmed Co.) Pharmacokinetic Study · Phase 3 · completed
- NCT07273760 — VedAryo® (Vedolizumab) Effectiveness and Safety Evaluation · completed
- NCT03935334 — Clinical Trial Comparing a Biosimilar Eptacog Alfa With Novoseven, in Patients With Hemophilia With Inhibitors · Phase 3 · completed
- NCT03293108 — Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Denosumab 60 mg (Arylia) Versus Prolia® in Improvement of Bo · Phase 3 · unknown
- NCT03079063 — Study Comparing the Pharmacokinetic of Biosimilar Eptacog Alfa With Novoseven®, in Patients With Congenital Factor VII D · Phase 3 · completed
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 NCT04789954 (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 AryoGen Pharmed Co.
- Last refreshed: 10 September 2022
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/NCT04789954.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing