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Monoclonal Antibodies
NXT007 Dose Escalation for Hemophilia A
Phase 1 & 2
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline until study completion or discontinuation (up to 7.5 years)
Awards & highlights
Study Summary
This trial is looking at the safety and effectiveness of giving multiple doses of NXT007 to men and boys with severe or moderate hemophilia A. The study will include participants from around the world and will investigate
Who is the study for?
This trial is for males with severe or moderate Hemophilia A, weighing over 40 kg. They must have a history of bleeding episodes and be willing to follow the study's procedures. Participants can't join if they have poor kidney, liver, or blood function.Check my eligibility
What is being tested?
The trial tests NXT007 in adults and teens with Hemophilia A to see how safe it is and how well it works at different doses. It's an early-stage (Phase I/II) global study where everyone gets the drug; there's no comparison group.See study design
What are the potential side effects?
Since this is an early-phase trial for NXT007, specific side effects are being studied but may include reactions related to immune response, infusion site reactions, and potential impacts on liver or kidney functions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline until study completion or discontinuation (up to 7.5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline until study completion or discontinuation (up to 7.5 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Grading Scale
Number of Participants with at Least One Abnormality on Electrocardiogram (ECG) Recordings
Number of Participants with at Least One Clinical Laboratory Test Abnormality for Blood Chemistry Parameters
+2 moreSecondary outcome measures
Area Under the Plasma Concentration-Time Curve (AUC) of NXT007 After the First Dose
Maximum Observed Plasma Concentration (Cmax) of NXT007 After the First Dose
Mean Calculated Annualized Bleeding Rate for All Bleeds
+15 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: NXT007 Dose EscalationExperimental Treatment1 Intervention
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Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,434 Previous Clinical Trials
1,091,352 Total Patients Enrolled
13 Trials studying Hemophilia A
1,336 Patients Enrolled for Hemophilia A
Clinical TrialsStudy DirectorHoffmann-La Roche
2,202 Previous Clinical Trials
889,996 Total Patients Enrolled
14 Trials studying Hemophilia A
1,303 Patients Enrolled for Hemophilia A
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