Drug Use Investigation of Kovaltry in Hemophilia A Patients

Status Active, not recruiting

Clinical Trial Summary

The objective in this study is collecting post-marketing information on the safety and efficacy of Kovaltry under the routine clinical practice.

Clinical Trial Description

This company-sponsored study is a single-arm, prospective, observational study in hemophilia A patients administered Kovaltry. 200 cases will be planned to be registered as safety analysis set in three-year period. Within 200 cases, 50 cases less than 12 years old will be planned to be registered. Target population are all hemophilia A patients. The treatment should be performed based on the product label in Japan. The standard observation period is two years. ;

Study Design

Related Conditions & MeSH terms

Hemophilia A

Clinical Trial Details

NCT number	NCT02941783
Study type	Observational
Source	Bayer
Contact
Status	Active, not recruiting
Phase
Start date	November 30, 2016
Completion date	September 30, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03834727` - Characterizing the Impact and Treatment of Reproductive Tract Bleeding on Women and Post-menarchal Girls With Bleeding Disorders
Completed	`NCT03191799` - A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors	Phase 3
Completed	`NCT01599819` - BAX 855 Dose-Escalation Safety Study	Phase 1
Terminated	`NCT04541628` - Safety & Efficacy of Encapsulated Allogeneic FVIII Cell Therapy in Haemophilia A	Phase 1/Phase 2
Completed	`NCT02847637` - A Clinical Trial to Evaluate Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants Without Inhibitors	Phase 3
Completed	`NCT04072237` - Study of Coagulation Faction VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia	Phase 1
Completed	`NCT04085458` - Study to Gain More Information on How Safe and Effective Jivi Works in Patients With Severe Hemophilia A (Post-marketing Investigation)	Phase 4
Completed	`NCT04565236` - A Post Approval Commitment Study to Gain More Information on How Safe and Effective KOVALTRY is in Chinese Children, Adolescents /Adults With Severe Hemophilia A	Phase 4
Recruiting	`NCT05987449` - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A	Phase 1/Phase 2
Active, not recruiting	`NCT04621916` - Preventing Inhibitor Recurrence Indefinitely	Phase 4
Not yet recruiting	`NCT02888223` - Pharmacokinetic Study of SCT800 in Previously Treated Patients With Hemophilia A	Phase 1
Completed	`NCT02528968` - National Study of a Pharmacokinetic-Focused Educational Package for Patients With Severe Haemophilia A	N/A
Completed	`NCT02225483` - Phenotypic Heterogeneity in Hemophilia A: An Investigation of the Role of Platelet Function	N/A
Completed	`NCT02199717` - An Institutional Pilot Study to Investigate Physical Activity Patterns in Boys With Hemophilia	N/A
Completed	`NCT01217255` - Comparing the Burden of Illness of Hemophilia in the Developing and the Developed World
Completed	`NCT00969319` - Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America	N/A
Terminated	`NCT00995046` - Individually Tailored Prophylaxis in Patients With Severe Hemophilia A	N/A
Completed	`NCT00868530` - Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects	Phase 3
Completed	`NCT00839202` - Activity and Content of Factor VIII (FVIII) in Human Plasma: The Assessment of a Novel Immunoassay	N/A
Completed	`NCT00629837` - Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980	Phase 1