A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A

Part of paid clinical trials in Sacramento, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT05987449
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Hemophilia A

Eligibility Criteria

Sex
MALE
Age
2 Years - 59 Years
Healthy Volunteers
Not accepted

Interventions

  • NXT007 — DRUG
    Participants will receive NXT007 administered subcutaneously (SC), 2 loading doses once every two weeks (Q2W) followed by once every 4 weeks (Q4W) maintenance doses based on the schedule.

Study Details

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.

Key Dates

Start date
Sep 21, 2023
Status verified
Jun 2026
Primary completion
Jun 16, 2030
Completion
Jun 16, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Cohort 1 - NXT007 Dose Level 1 (Low)
  • Experimental: Part 1: Cohort 2 - NXT007 Dose Level 2
  • Experimental: Part 1: Cohort 3 - NXT007 Dose Level 3
  • Experimental: Part 1: Cohort 4 - NXT007 Dose Level 4
  • Experimental: Part 1: Cohort 5 - NXT007 Dose Level 5 (High)
  • Experimental: Part 2: Cohort A - NXT007

Primary Outcome Measure

Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Grading Scale [ Time Frame: From Baseline until study completion or discontinuation (up to 7.5 years) ]

Central Contacts

  • Reference Study ID Number: WP44714 https://forpatients.roche.com/
    888-662-6728 (U.S. Only)
    [email protected]
  • Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (4)

FacilityCityStateZIPSite coordinators
UC Davis Cancer CenterSacramentoCalifornia95817-
Georgetown Uni Medical CenterWashington D.C.District of Columbia20007-
Indiana Hemophilia & Thrombosis centerIndianapolisIndiana46260-
University of Iowa Hospitals and Clnics Dept of PediatricsIowa CityIowa52242-

Find similar trials in Sacramento, CA

By research site
UC Davis Cancer Center· Sacramento, CAGeorgetown Uni Medical Center· Washington D.C., DCIndiana Hemophilia & Thrombosis center· Indianapolis, INUniversity of Iowa Hospitals and Clnics Dept of Pediatrics· Iowa City, IA

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