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NCT02941783 Clinical Trial

Drug Use Investigation of Kovaltry in Hemophilia A Patients

Hemophilia A Clinical Trial

Official title:
Drug Use Investigation of Kovaltry in Hemophilia A Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02941783
Other study ID # 18706
Secondary ID 2015/01011
Status Active, not recruiting
Phase
First received
Last updated
Start date November 30, 2016
Est. completion date September 30, 2025

Study information
Verified date May 2024
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 231
Est. completion date September 30, 2025
Est. primary completion date March 23, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Male and female hemophilia A patients. - Patients for whom the decision to treat with Kovaltry was determined prior to enrollment in the study. Exclusion Criteria: - Patients participating in an investigational program with interventions outside of routine clinical practice. - Patients with an additional diagnosis of any bleeding/coagulation disorder other than hemophilia A

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)
Treatment parameters following the physician's decision based on the summary of product characteristics.

Locations
Country Name City State
Japan Many Locations Multiple Locations

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with adverse events as measure of safety and tolerability Up to 2 years
Primary Number of participants with serious adverse events as measure of safety and tolerability Up to 2 years
Secondary Number of annual bleeds Up to 2 years
Secondary Efficacy of controlling of bleeds The efficacy is evaluated by the investigator and given on a four point scale: Excellent, Good, Moderate and Poor. Up to 2 years
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