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NOT YET RECRUITING
NCT07838194
PHASE3

Clinical Trial of NXT007 for the Prophylactic Treatment of Hemophilia A in Infants and Children

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of NXT007 prophylaxis in pediatric patients aged 0 to 11 years with severe or moderate congenital hemophilia A without factor VIII inhibitors or congenital hemophilia A of any severity (severe, moderate, and mild) with inhibitors (emicizumab-naïve and treated). Patients with hemophilia A aged ≥12 to \<18 years old with a body weight of \<40 kilograms (kg) are also able to participate.

Official title: A Multicenter, Open-Label, Single-Arm, Phase III Clinical Trial to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of NXT007 Prophylaxis in Pediatric Patients With Hemophilia A

Key Details

Gender

All

Age Range

0 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-11-30

Completion Date

2031-09-30

Last Updated

2026-10-19

Healthy Volunteers

No

Conditions

Interventions

DRUG

NXT007

NXT007 will be administered subcutaneously (SC) according to the schedule in the protocol.