NXT007
Sponsors
F. Hoffmann-La Roche AG, Hoffmann-La Roche
Conditions
Healthy Male ParticipantsHemophilia AHemophilia A Without InhibitorsSevere or Moderate Hemophilia A with or without factor VIII inhibitors
Phase 1
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
RecruitingNCT05987449
Start: 2023-09-21End: 2033-12-11Target: 60Updated: 2026-07-06
A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons with Severe or Moderate Hemophilia A
RecruitingCTIS2023-503906-35-00
Start: 2023-10-11Target: 16Updated: 2025-11-26
A Study to Evaluate Single Subcutaneous Doses of NXT007 Among Injection Sites Abdomen, Upper Arm, and Thigh in Healthy Male Participants
CompletedNCT06189508
Start: 2024-02-14End: 2024-12-22Updated: 2025-01-15
Phase 3
A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A
RecruitingNCT07416526
Start: 2026-05-15End: 2031-09-23Target: 126Updated: 2026-07-07
A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A
RecruitingNCT07416604
Start: 2026-04-27End: 2032-01-29Target: 360Updated: 2026-07-07
A MULTICENTER, RANDOMIZED, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF NXT007 PROPHYLAXIS VERSUS EMICIZUMAB PROPHYLAXIS IN PEOPLE WITH HEMOPHILIA A
Not yet recruitingCTIS2025-522435-33-00
Target: 43Updated: 2026-06-02
A MULTICENTER, RANDOMIZED, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF NXT007 PROPHYLAXIS VERSUS FACTOR VIII PROPHYLAXIS IN PEOPLE WITH HEMOPHILIA A WITHOUT INHIBITORS
Not yet recruitingCTIS2025-522434-32-00
Target: 4Updated: 2026-06-02