NCT02941783

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

November 30, 2016

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2022

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2025

Completed
Last Updated

October 23, 2025

Status Verified

October 1, 2025

Enrollment Period

5.3 years

First QC Date

October 20, 2016

Last Update Submit

October 22, 2025

Conditions

Hemophilia A

Keywords

Kovaltryhemophilia AJapanPost-marketing surveillance

Outcome Measures

Primary Outcomes (2)

  • Number of participants with adverse events as measure of safety and tolerability

    Up to 2 years

  • Number of participants with serious adverse events as measure of safety and tolerability

    Up to 2 years

Secondary Outcomes (2)

  • Number of annual bleeds

    Up to 2 years

  • Efficacy of controlling of bleeds

    Up to 2 years

Study Arms (1)

BAY81-8973

Hemophilia A patients who require Factor VIII replacement therapy

Drug: Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)

Interventions

Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)DRUG

Treatment parameters following the physician's decision based on the summary of product characteristics.

BAY81-8973

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male and female hemophilia A patients are registered after the decision for treatment with Kovaltry has been made by the investigator. Both 'on demand' and 'prophylaxis' treatment are included.

You may qualify if:

  • Male and female hemophilia A patients.
  • Patients for whom the decision to treat with Kovaltry was determined prior to enrollment in the study.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Many Locations

Multiple Locations, Japan

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

F8 protein, humanFactor VIII

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBiological Factors

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2016

First Posted

October 21, 2016

Study Start

November 30, 2016

Primary Completion

March 23, 2022

Study Completion

September 16, 2025

Last Updated

October 23, 2025

Record last verified: 2025-10

Locations

JP(1)