drugset / Trial / NCT02888223

Pharmacokinetic Study of SCT800 in Previously Treated Patients With Hemophilia A

NCT02888223

Phase 1 Unknown 16 enrolled Sinocelltech Ltd.
RandomizedCrossoverOpen-labelTreatment

Summary

Participants will be assigned to A or B groups with a scale of 1:1 based on a prospectively randomized treatment-sequence assignment, i.e. infuse SCT800 followed by Xyntha (group A), or the alternate sequence (group B). All participants who completed the SCT800HA1 study will enter the efficacy and safety study (Protocol No.: SCT800HA3).

Timeline

Start
2016-09
Primary completion
2017-02
Completion
2017-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Moroctocog alfa Protein / enzyme biologic 50 iu/kg
Subject SCT800 Protein / enzyme biologic 50 iu/kg

Indications