Hemophilia B clinical trials
The registry lists 292 studies for Hemophilia B across more than 10 countries. 51 are recruiting or about to start. 127 of them are mainly about Hemophilia B (how this is decided). Per ClinicalTrials.gov, last updated 2026-11-09.
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Status
Who runs them
Novo Nordisk A/S (55) · Pfizer (22) · CSL Behring (18) · Baxalta now part of Shire (17) · Wyeth is now a wholly owned subsidiary of Pfizer (11) · Institute of Hematology & Blood Diseases Hospital, China (7) · Swedish Orphan Biovitrum (7) · Bio Products Laboratory (5)
What is being tested here
Drugs under test in Hemophilia B studies, those with the most open studies first. Medicines only given beside them are not counted. How drugs are counted
Coming up
Studies recruiting or running, from their records. “Main data collection” ends at the primary completion date, the sponsor’s own estimate, which often moves.
All 8, phase 3 first
- Apr 2027An Open-Label, Comparative Study of the Efficacy, Safety and Pharmacodynamics of Single Dose of ANB-002 in Patients With Hemophilia B · Phase 3 · Biocad
- Sep 2027A Phase III Clinical Trial Evaluating SR604 Injection for Prophylactic Treatment in Patients With Hemophilia · Phase 3 · Shanghai RAAS Blood Products Co., Ltd.
- Nov 2026A Trial That Evaluates Disease Characteristics in Hemophilia B Adult Male Participants Receiving Prophylaxis With Standard of Care Factor IX Protein (FIX) Replacement Therapy · Regeneron Pharmaceuticals
- Nov 2026Early Check: Expanded Screening in Newborns · RTI International
- Dec 2026An Open-label, Multicenter Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetic/Pharmacodynamic (PK/PD) Characteristics of SR604 Injection in Patients With Hemophilia A/B and Congenital Factor VII Deficiency · Shanghai RAAS Blood Products Co., Ltd.
- May 2027Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders · Assistance Publique - Hôpitaux de Paris
- Jul 2027Safety of Intraosseous Anaesthesia in Children With Haemophilia · Ankara Yildirim Beyazıt University
- Oct 2027Adverse Event Data Collection From External Registries on Nonacog Beta Pegol · Novo Nordisk A/S
Who these studies take
Of the 30 Hemophilia B studies recruiting now, 17 (57%) set no upper age limit and 11 (37%) stop at 75 or younger. 16 (53%) take children under 18. 1 (3%) are for women only and 13 (43%) for men only; 3 (10%) take healthy volunteers.
| Age | Women | Men |
|---|---|---|
| 10 | 8 (27%) | 11 (37%) |
| 18 | 16 (53%) | 26 (87%) |
| 30 | 16 (53%) | 25 (83%) |
| 40 | 16 (53%) | 25 (83%) |
| 50 | 16 (53%) | 25 (83%) |
| 65 | 15 (50%) | 24 (80%) |
| 75 | 13 (43%) | 20 (67%) |
| 85 | 12 (40%) | 17 (57%) |
Across all 292 studies, recruiting or not: 40% stop at 75 or younger and 34% at 65; 62% take children; 2% are for women only and 54% for men only; 9% take healthy volunteers. From each study’s registry entry; the criteria on its page decide.
How long Hemophilia B studies take
Of 35 phase 3 interventional studies under Hemophilia B, half reached primary completion within 38 months of starting, counting those still running.
| Start to primary completion | Every sponsor | Industry | Non-industry |
|---|---|---|---|
| Phase 1 | 22 mo7–42 · 15 studies | — | — |
| Phase 2 | 12 mo9–18 · 10 studies | — | — |
| Phase 3 | 38 mo23–70 · 35 studies | 38 mo23–70 · 35 studies | — |
| Observational | 45 mo33–105 · 42 studies | — | — |
Each figure is the month by which half the studies had reached primary completion, with the range in which the middle half did. Studies still running count until their last registry update; studies that stopped early are left out. Phase 1 includes early phase 1; observational means prospective or not stated, as retrospective and cross-sectional studies date a window of data rather than a study. How these figures are worked out
What changed recently
From the registry's own updates since Oct 14, 2026.
Stopped2
- SAFE Study: Safety of aPCC Following Emicizumab ProphylaxisWithdrawnNov 6, 2026NCT04563520
- Factor In the Initial Resuscitation of Severe Trauma 2 PatientsTerminatedOct 21, 2026NCT04534751
Newly registered3
- A Study to Assess the Safety of Marstacimab and How Well it Works in People With Mild to Moderate Hemophilia A or B Without InhibitorsNov 9, 2026NCT07923981
- Safety of Intraosseous Anaesthesia in Children With HaemophiliaNov 4, 2026NCT07916467
- A Phase III Clinical Trial Evaluating SR604 Injection for Prophylactic Treatment in Patients With HemophiliaOct 15, 2026NCT07876674
Studies
Recruiting first, then most recently updated. Showing 50 of 292. Browse all 292 → or search them.
- A Study to Assess the Safety of Marstacimab and How Well it Works in People With Mild to Moderate Hemophilia A or B Without InhibitorsRecruitingNCT07923981Phase 31 country
- Safety of Intraosseous Anaesthesia in Children With HaemophiliaNot yet recruitingNCT07916467Not applicable1 country
- Lentiviral FIX Gene TherapyNot yet recruitingNCT03961243Phase 11 country
- Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without InhibitorsRecruitingNCT05145127Phase 324 countries
- Liver Biopsy Following Gene Therapy For HemophiliaNot yet recruitingNCT059329141 country
- Development of Non-Invasive Prenatal Diagnosis for Single Gene DisordersRecruitingNCT061474141 country
- A Study to Investigate the Safety and Effectiveness of a Coagulation Factor IX Gene Insertion Therapy (REGV131-LNP1265) in Pediatric, Adolescent and Adult Participants With Hemophilia BRecruitingNCT06379789Phase 1/29 countries
- Phase 3, Open-label, Single-dose Study of CSL222 in Adolescent Male Subjects (≥ 12 to < 18 Years of Age) With Severe or Moderately Severe Hemophilia BRecruitingNCT07080905Phase 38 countries
- A Phase III Clinical Trial Evaluating SR604 Injection for Prophylactic Treatment in Patients With HemophiliaNot yet recruitingNCT07876674Phase 3
- A Clinical Trial of Study Medicine (Marstacimab) in Pediatric Patients With Hemophilia A or Hemophilia BRecruitingNCT05611801Phase 323 countries
- Adverse Event Data Collection From External Registries on Nonacog Beta PegolEnrolling by invitationNCT036903362 countries
- Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B RespectivelyRecruitingNCT05568719Phase 313 countries
- Multicomponent Pain Self-Management in Adults With Haemophilic ArthropathyNot yet recruitingNCT07860632Not applicable1 country
- A Study to Learn About the Study Medicine (Called Marstacimab) in People With Hemophilia A or BNot yet recruitingNCT07859527
- Efficacy and Safety of CSL222 (Etranacogene Dezaparvovec) Gene Therapy in Adults With Hemophilia B With Pretreatment Adeno-associated Virus Serotype 5 (AAV5) Neutralizing Antibodies (Nabs)RecruitingNCT06003387Phase 315 countries
- Ultrasound Assessment of Joint Health in Patients With Mild Hemophilia (Factor Levels 5-40%)Not yet recruitingNCT07719647Not applicable1 country
- ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic DisordersRecruitingNCT043986281 country
- CD19-B Cell Depletion in PAIS-ME/CFS PatientsNot yet recruitingNCT07724834Phase 21 country
- Post-acute Infectious Syndrome - Aripiprazole Symptom Evaluation (PAIS-AriSE)Not yet recruitingNCT07714213Phase 21 country
- A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SR604 in Two Participants Groups (Part A: Healthy Participants, and Part B: Participants With Hemophilia A or Hemophilia B or Factor VII Deficiency)RecruitingNCT06349473Phase 12 countries
- Effects of Anisodamine on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic ShockNot yet recruitingNCT07657702Not applicable1 country
- Effects of Dexmedetomidine on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic ShockNot yet recruitingNCT07657715Not applicable1 country
- Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Cardiac SurgeryRecruitingNCT06144125Phase 41 country
- Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With InhibitorsEnrolling by invitationNCT062850711 country
- Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With AlhemoEnrolling by invitationNCT068317341 country
- An Open-label, Multicenter Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetic/Pharmacodynamic (PK/PD) Characteristics of SR604 Injection in Patients With Hemophilia A/B and Congenital Factor VII DeficiencyRecruitingNCT07644832Phase 1/21 country
- A Study Following Males With Haemophilia B on Prophylaxis With Refixia/REBINYNEnrolling by invitationNCT0374592413 countries
- Synovial Proliferation on Routine Ultrasound: Active or Inactive?RecruitingNCT068099721 country
- ATHNdataset RegistryRecruitingNCT068205151 country
- An Observational Cohort Study to Characterize the Effectiveness and Safety of HEMGENIX® in Patients With Hemophilia BRecruitingNCT060089387 countries
- National Longitudinal Cohort of Hematological DiseasesRecruitingNCT046451991 country
- SEVENFACT® for Bleeding Events in Hemophilia With InhibitorsRecruitingNCT04647227Phase 41 country
- An Open-Label, Comparative Study of the Efficacy, Safety and Pharmacodynamics of Single Dose of ANB-002 in Patients With Hemophilia BRecruitingNCT06700096Phase 32 countries
- The European Paediatric Network for Haemophilia Management ( PedNet Registry)RecruitingNCT0297911919 countries
- Long-term Follow-up Study of Male Adults With Hemophilia B Previously Treated With Etranacogene Dezaparvovec (CSL222)Enrolling by invitationNCT059623988 countries
- Study of the Safety, Pharmacodynamics and Efficacy of ANB-002 in Patients With Hemophilia B (SAFRAN)RecruitingNCT06120582Phase 1/22 countries
- The Efficacy and Safety of ZS801 in Chinese Hemophilia B Patients.RecruitingNCT05630651Not applicable1 country
- A Study to Evaluate the Safety and Efficacy of ZS801 in Adult Hemophilia B PatientsRecruitingNCT05641610Phase 1/21 country
- Gene Therapy for Hemophilia B Patients Aged 12-18 Years OldRecruitingNCT05709288Phase 11 country
- Safety and Tolerability of VGB-R04 in Patients With Haemophilia BRecruitingNCT05152732Early Phase 11 country
- Measurement Properties in People with HemophiliaRecruitingNCT06565481Not applicable1 country
- Liver Biopsy In Haemophilia Gene TherapyRecruitingNCT04817462Not applicable1 country
- Longitudinal Cohort of Thrombosis and Hemostasis DiseasesRecruitingNCT067276691 country
- Study of Surgical Practices in Patients With Haemophilia A or B Treated With an Extended Half-life Recombinant Factor VIII-Fc or IX-Fc (ELOCTA®, ALPROLIX®)RecruitingNCT061583341 country
- Safety and Efficacy Clinical Study of Severe Hemophilia B Treatment With KL001Not yet recruitingNCT06125756Early Phase 1
- Safety and Efficacy Clinical Study of Severe Hemophilia B Treatment With KL001Not yet recruitingNCT06119659Early Phase 1
- Alterations in Coagulation Factor Levels in Patients With End Stage Liver DiseaseNot yet recruitingNCT060143201 country
- World Bleeding Disorders RegistryRecruitingNCT033277791 country
- Patterns of Hemophilia Care in Assiut Children PatientsNot yet recruitingNCT05980377
- Viscoelastic Properties of Lower Extremity Muscles in Patients With HemophiliaNot yet recruitingNCT059813131 country