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Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America | Clinical Trials | Clareo Health

COMPLETED

Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America

NCT00969319•Bayer

View on ClinicalTrials.gov

Summary

The aim of this international prospective post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer/FS in treatment of patients with haemophilia A under daily-life treatment conditions.

Eligibility

Age

All ages

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Patients with diagnosis of hemophilia A, independent of age, treated with KOGENATE® FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE® FS. For pretreated patients with more than 100 exposure days an inhibitor assessment within three months prior to enrollment should be available; for pretreated patients with less than 100 exposure days an inhibitor assessment at baseline should be available.

Locations (2)

Many Locations, Mexico

Many Locations, Venezuela

Key Dates

Start Date

September 1, 2009

Primary Completion Date

February 1, 2013

Completion Date

February 1, 2014

Last Updated

January 19, 2015

Enrollment

105

ACTUAL participants

Conditions

Blood Coagulation DisordersHemophilia A

Interventions

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

BIOLOGICAL

A Gene Therapy Study of SPK-8011QQ in Adults With Severe or Moderately Severe Hemophilia A

NCT07226206

Hemophilia A

View study

RECRUITINGPHASE1/PHASE2

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A

NCT05987449

Hemophilia A

View study

RECRUITING

National Longitudinal Cohort of Hematological Diseases

NCT04645199

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 19, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America

Inclusion Criteria

A Gene Therapy Study of SPK-8011QQ in Adults With Severe or Moderately Severe Hemophilia A

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A

National Longitudinal Cohort of Hematological Diseases

A Study to Learn About How Changing Therapy From Emicizumab to Marstacimab Affects People With the Severe Hemophilia A.

Evaluation of Hemostasis in Bleeding and Thrombotic Disorders

Home Monitoring in Hemophilia a