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NCT05987449
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Conditions: Hemophilia A
Sex: Male
Ages: 2 Years – 59 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 60
Sponsor: Hoffmann-La Roche
Location: UC Davis Cancer Center Sacramento California
Summary
WP44714 is a Phase I/II, open-label, non-randomized, global, multicenter trial consisting of two parts:
* Part 1 is a multiple-ascending dose (MAD) study in adult and adolescent male participants with severe or moderate hemophilia A with or without factor VIII (FVIII) inhibitors.
* Part 2 is a multiple-dose study in pediatric male participants with severe or moderate hemophilia A with or without FVIII inhibitors.
The overall aim of the study is to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of NXT007.
Eligibility Criteria
Inclusion Criteria:
* Diagnosis of severe (Factor VIII \[FVIII\] coagulant activity \30 minutes apart
* History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease (e.g., severe left ventricular systolic dysfunction, left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome
* Current treatment with medications that are well known to prolong the QT interval
Source: ClinicalTrials.gov (NCT05987449). StuddyBuddy aggregates publicly available trial information.
