Hemophilia Clinical Trial
Official title:
A Phase 1b, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous MG1113 in Patients With Severe Hemophilia
The purpose of this study is to assess the safety and tolerability, pharmacokinetics and pharmacodynamics of subcutaneous MG1113 in the multiple ascending dose study in patients with severe hemophilia.
This is a repeat-dose study that assign 5 subjects in each cohort to explore the safety, tolerability, PK, and PD of the study drug by sequentially increasing the study drug. The route of administration is subcutaneous (SC) injection. Dose escalation will be decided after checking the safety and tolerability at the previous dose to the extent not exceeding the criteria for discontinuation of dose escalation. The dose escalation will be decided by the Steering Committee and Data and Safety Monitoring Boards (DSMB) in the evaluation of the safety and tolerability data obtained from each cohort after repeated administration of MG1113. The subjects will be treated with 2.0 mg/kg once weekly for 8 weeks in cohort 1. Visit window of ±1 day (calculated from Day1) are allowed for the dosing schedule after first IP administration (Day 1). But next scheduled IP administration must be kept in mind to ensure subjects will not have more than 8 days in between IP dosing interval. The next dose level (Dose A and B) will be determined based on the safety, PK, and PD data obtained from previous dose level. If a criterion of discontinuation of dose escalation is fulfilled, discussion about dose escalation is available for next cohort. The dose selection and escalation will be finally determined from the Steering Committee and DSMB. The safety, tolerability, PK, and PD data obtained from all subjects up to Cohort 3 will be evaluated by the Steering Committee and Data and Safety Monitoring Boards (DSMB). ;
| 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
|
||
| Unknown status |
NCT02433782 -
Myofascial Therapy in Patients With Hemophilic Arthropathy
|
N/A | |
| Completed |
NCT02546622 -
ATHN 2: Factor Switching Study
|
||
| Terminated |
NCT02586012 -
Weight-based Dosing in Hemophilia A
|
Phase 2 | |
| Unknown status |
NCT02165592 -
Assessment of Proprioceptive and Functional Characteristics in Patients With Hemophilia
|
N/A | |
| Completed |
NCT02165462 -
Bilateral Deficit Phenomenon in Patients With Haemophilic Arthropathy
|
N/A | |
| 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
|