Clinical Trials Logo

Clinical Trial Summary

This is a multi-center, single-arm, open-label, single-dose treatment clinical study to evaluate the safety, tolerability and efficacy of BBM-H901 injection in Hemophilia B subjects with ≤2 International unit per deciliter (IU/dl) residual factor IX (FIX) levels. BBM-H901 is an adeno-associated virus (AAV) vector derived from recombinant DNA techniques to contain an expression cassette of the human factor IX (hFIX) transgene and raises circulating levels of endogenous FIX.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05203679
Study type Interventional
Source Shanghai Belief-Delivery BioMed Co., Ltd
Status Active, not recruiting
Phase Phase 3
Start date December 30, 2021
Completion date June 30, 2028

See also
  Status Clinical Trial Phase
Completed NCT04072237 - Study of Coagulation Faction VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia Phase 1
Completed NCT02199717 - An Institutional Pilot Study to Investigate Physical Activity Patterns in Boys With Hemophilia N/A
Completed NCT01662531 - A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B Phase 3
Completed NCT01335061 - Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of BeneFIX In Subjects With Moderately Severe to Severe Hemophilia B Phase 3
Completed NCT01217255 - Comparing the Burden of Illness of Hemophilia in the Developing and the Developed World
Completed NCT00037557 - Study Evaluating rFIX; BeneFIX in Severe Hemophilia B Phase 3
Completed NCT02554773 - An Open-label Extension Study of an Investigational Drug, Fitusiran, in Patients With Moderate or Severe Hemophilia A or B Phase 1/Phase 2
Terminated NCT02807753 - The Hemophilia Ultrasound Project
Active, not recruiting NCT03901755 - An International Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B
Not yet recruiting NCT05980377 - Patterns of Hemophilia Care in Assiut Children Patients
Recruiting NCT05687474 - Baby Detect : Genomic Newborn Screening
Terminated NCT03248141 - Understanding Hemophilia A and B Drug Dosage Administration Patterns
Terminated NCT01460147 - Osteoporosis and MRI Study in Hemophilia N/A
Completed NCT03818529 - ATHN 8: Previously Untreated Patients (PUPs) Matter Study
Completed NCT02571569 - A Single Escalating Dose and Multiple Dose Study of BAY 1093884 in Subjects With Severe Hemophilia Types A or B, With or Without Inhibitors Phase 1
Terminated NCT01620801 - Hemophilia B Gene Therapy With AAV8 Vector Phase 1
Completed NCT01233440 - Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein in Subjects With Hemophilia B Phase 1
Recruiting NCT06003387 - 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) Phase 3
Active, not recruiting NCT04135300 - Gene Therapy for Chinese Hemophilia B N/A
Enrolling by invitation NCT03655223 - Early Check: Expanded Screening in Newborns