KN057 Multiple Dose Study in Moderately Severe to Severe Hemophilia

Status Recruiting

Clinical Trial Summary

This study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of multiple subcutaneous doses of KN057 in subjects with hemophilia A or B, with or without inhibitors to Factor VIII (FVIII) or Factor IX (FIX). 24 adult participants 18 to 70 years of age with moderately severe to severe hemophilia A or hemophilia B (defined as FVIII or FIX activity ≤2%, respectively) with or without inhibitors (including 18 HA/HB patients without inhibitors and 6 HA/HB patients with inhibitors) are expected to be enrolled in this study during which they will receive prophylaxis treatment (defined as treatment by SC injection once weekly of KN057).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05421429
Study type	Interventional
Source	Suzhou Alphamab Co., Ltd.
Contact	Yanrong Dong, Master
Phone	+86 18914005458
Email	yanrongdong@alphamab.com
Status	Recruiting
Phase	Phase 2
Start date	July 7, 2022
Completion date	June 30, 2024

View Details

See also
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	`NCT02165462` - Bilateral Deficit Phenomenon in Patients With Haemophilic Arthropathy	N/A
Unknown status	`NCT02433782` - Myofascial Therapy in Patients With Hemophilic Arthropathy	N/A
Unknown status	`NCT02165592` - Assessment of Proprioceptive and Functional Characteristics in Patients With Hemophilia	N/A
Completed	`NCT02546622` - ATHN 2: Factor Switching Study
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