Hemophilia Clinical Trial
Official title:
A Phase 3, Single-arm, Multicenter, Multinational, Open-label, One-way Crossover Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged ≥ 12 Years With Severe Hemophilia A or B With or Without Inhibitory Antibodies to Factor VIII or IX
This is a multicenter, multinational, open-label, one-way cross-over, Phase 3, single-arm study for treatment of hemophilia. The purpose of this study is to measure the frequency of treated bleeding episodes with fitusiran in male adult and adolescent (≥12 years old) participants with hemophilia A or B, with or without inhibitory antibodies to factor VIII or IX who have switched from their prior standard of care treatment. The total study duration will be up to approximately 50 months (200 weeks, 1 study month is equivalent to 4 weeks) and will include: - A screening period up to approximately 60 days, - A standard of care (SOC) period of approximately 6 study months (24 weeks), - A fitusiran treatment period of approximately 36 study months (144 weeks), - An antithrombin (AT) follow-up period of approximately 6 study months (24 weeks) but may be shorter or longer depending on individual participants AT recovery. The frequency for telephone visits will be approximately every 2 weeks. For site visits the frequency will be approximately every 8 weeks during the SOC period and approximately every 4 weeks during the fitusiran treatment period. If applicable and if allowed by local regulation, home and/or remote visits may be conducted during the study
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05617209 -
In Vitro Correction of Thrombin Generation by Concizumab (Anti-TFPI) for Severe Hemophilia Patients
|
||
| Completed |
NCT05039008 -
Restricting Blood Flow in Improving Muscle Strength in Patients With Hemophilic Arthropathy
|
N/A | |
| Recruiting |
NCT04398628 -
ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
|
||
| Completed |
NCT02546622 -
ATHN 2: Factor Switching Study
|
||
| Completed |
NCT02165462 -
Bilateral Deficit Phenomenon in Patients With Haemophilic Arthropathy
|
N/A | |
| Unknown status |
NCT02165592 -
Assessment of Proprioceptive and Functional Characteristics in Patients With Hemophilia
|
N/A | |
| Unknown status |
NCT02433782 -
Myofascial Therapy in Patients With Hemophilic Arthropathy
|
N/A | |
| Terminated |
NCT02586012 -
Weight-based Dosing in Hemophilia A
|
Phase 2 | |
| Completed |
NCT01232634 -
Validation of Ultrasound as a Diagnostic Tool for Assessment of Hemophilic Arthropathy of Knees and Ankles
|
Phase 2 | |
| Completed |
NCT05104164 -
Self-myofascial Release in Hemophilic Ankle Arthropathy
|
N/A | |
| Terminated |
NCT01191372 -
First-in-Human and Proof-of-Mechanism Study of ARC19499 Administered to Hemophilia Patients
|
Phase 1 | |
| Completed |
NCT05173129 -
Posture Analysis for Patients With Haemophilia
|
N/A | |
| Completed |
NCT03818529 -
ATHN 8: Previously Untreated Patients (PUPs) Matter Study
|
||
| Withdrawn |
NCT03996486 -
Study to Test the Safety of an Investigational Drug Given Repeatedly to Adult Men With Severe Hemophilia
|
Phase 1 | |
| Completed |
NCT01708564 -
A Phase I Safety, Pharmacokinetics and Pharmacodynamics Study of Recombinant Factor VIIa in Adult Patients With Hemophilia A or B
|
Phase 1 | |
| Completed |
NCT03842605 -
Efficacy of Strength Training in Improving Elbow Range of Motion and Function in Adults With Hemophilia
|
N/A | |
| Completed |
NCT05549843 -
Manual Therapy in the Treatment of Hemophilic Arthropathy of the Ankle
|
N/A | |
| Recruiting |
NCT06010953 -
SS109 and NovoSeven ® PK / PD Profile, and Preliminary Efficacy and Safety of SS109 on Demand Treatment
|
Phase 1/Phase 2 | |
| Completed |
NCT05027230 -
A Safety and Efficacy Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT06014320 -
Alterations in Coagulation Factor Levels in Patients With End Stage Liver Disease
|