Hemophilia B Clinical Trial
Official title:
An Open-label, Non-comparative, Single Dose-Escalation Study of the Safety, Pharmacodynamics and Efficacy of ANB-002 in Patients With Hemophilia B
The goal of this multicenter, two-stage, open-label study is to investigate the safety, immunogenicity, and efficacy of ANB-002 in subjects with hemophilia В. The study will have a dose-escalation design with elements of phase I/II seamless adaptive design.
The study design includes ANB-002 dose escalation in at least two cohorts. In Cohort 1, the subject treated with a single dose of ANB-002 administered as an intravenous infusion. Follow-up for the assessment of dose-limiting toxicity (DLT) will be carried out for 28 days. If no DLT events are observed in the subject of Cohort 1, the following subjects will be included in Cohort 1. The decision to continue enrolling in Cohort 1 or dosing in Cohort 2 subjects will be made at the Independent Data Monitoring Committee (IDMC) meeting. After the IDMC makes a decision regarding the dosing in Cohort 2 subjects, further enrolment to the cohort will be carried out according to the following principles described above. Based on the data from the follow-up period of subjects included in Сohorts 1 and 2, a potential therapeutic dose for further study will be determined. The total duration of participation of one subjects in the study will be 5 years. ;
| 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 | |
| Active, not recruiting |
NCT04135300 -
Gene Therapy for Chinese Hemophilia B
|
N/A | |
| Enrolling by invitation |
NCT03655223 -
Early Check: Expanded Screening in Newborns
|
||
| Terminated |
NCT00947193 -
Study of Ataluren (PTC124) in Hemophilia A and B
|
Phase 2 |