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Recombinant Factor VIIa BI (rFVIIa BI) Treatment of Acute Bleeding Episodes Per an On-demand Regimen

Information source: Baxalta US Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemophilia A; Hemophilia B

Intervention: Recombinant Factor VIIa BI (rFVIIa BI) (Biological); Recombinant Factor VIIa BI (rFVIIa BI) (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Baxalta US Inc.

Official(s) and/or principal investigator(s):
Heinrich Farin, MD, Study Director, Affiliation: Baxter Healthcare Corporation

Summary

The purpose of the study is to determine the efficacy and safety of rFVIIa BI as part of a six-month on-demand treatment regimen in hemophilia A or B subjects with inhibitors.

Clinical Details

Official title: A PHASE 3, PROSPECTIVE, OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE SAFETY AND EFFICACY OF RECOMBINANT ACTIVATED FVII BI (rFVIIa BI) IN THE TREATMENT OF ACUTE BLEEDING EPISODES PER AN ON-DEMAND REGIMEN IN PATIENTS WITH HEMOPHILIA A OR B WITH INHIBITORS

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Bleeding episode treatment success

Secondary outcome:

Treatment response for each bleeding episode

Percentage of clinical responders (sustained bleeding control) for all acute bleeding episodes

Safety and tolerability of treatment regimens by clinical assessment of adverse events (AEs)

Inhibitor development to FVII

Eligibility

Minimum age: 12 Years. Maximum age: 65 Years. Gender(s): Male.

Criteria:

Main Inclusion Criteria:

- Participant is male with hemophilia A or B with inhibitors, with a high titer (≥5

Bethesda unit (BU)) or a historical high anamnestic response.

- Participant is 12 to 65 years old at the time of screening.

- Participant is currently using or has used bypassing agents for treatment of bleeding

episodes.

- Participant has an annualized bleed rate of 5 or more bleeding episodes per year on

average over the 2 years prior to the Screening visit.

- Participant has a Karnofsky Performance Score ≥60.

- Participant is hepatitis C virus negative (HCV-) either by antibody testing or

polymerase chain reaction (PCR); or hepatitis C virus positive (HCV+) with stable hepatic disease.

- Participant is human immunodeficiency virus negative (HIV-) or HIV+ with stable

disease, CD4+ count ≥200 cells/mm^3 at screening.

- Participant is willing and able to comply with the requirements of the protocol.

Main Exclusion Criteria:

- Participant is not willing to go on an on-demand treatment scheme.

- Participant is positive for a FVII inhibitor at screening.

- Participant has clinically symptomatic liver disease.

- Participant has a platelet count <100,000/µL.

- The use of α-interferon with or without ribavirin is planned for an HCV-infected

participant or the use of a protease inhibitor is planned for an HIV-infected participant.

- Participants currently taking any of these medications for ≥30 days are

eligible.

- Participant has a known hypersensitivity to rFVIIa, hamster or murine proteins, or

Tween 80.

- Participant has a known history of being non-responsive to rFVIIa treatment of

bleeding episodes.

- Participant has a prior history of thromboembolic event or diagnosis of other

diseases that may increase the participant's risk of thromboembolic complications.

- Participant has participated in another clinical study involving an investigational

product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.

- Participant is a family member or employee of the investigator.

- Participant is scheduled for surgery during the study period.

Locations and Contacts

Nara Medical University Hospital, Nara-Ken 6348522, Japan

Tokyo Medical University Hospital, Tokyo 1600023, Japan

Kracow Medical Center, LLC, Krakow 31-501, Poland

Institute of Haematology and Transfusion Medicine, Clinic of Haemostatic Disorders and Internal Diseases, Warszawa 02-776, Poland

Louis Turcanu Emergency Clinical Children´s Hospital, Timisoara 300011, Romania

Kirov Hematology and Blood Transfusion Research Institute under the Federal Medical and Biological Agency of Russia, Kirov 610027, Russian Federation

Hematology Research Center under RAMS (State Institution), Department of Reconstructive Orthopedic Surgery for Hemophilia Patients, Moscow 125167, Russian Federation

St. Petersburg City Healthcare Institution Municipal Policlinic # 37, St. Petersburg 195213, Russian Federation

Clinic for Hematology of the Clinical Center of Serbia, Belgrade 11000, Serbia

Hospital Teresa Herrera Materno Infantil del C.H.U.Carretera del Pasajes/nlaboratorio de hematología, A Coruña 15006, Spain

University Hospital Virgen del Rocio, Sevilla 41013, Spain

Tri-Service General Hospital (TSGH), Taipei City 11490, Taiwan

V.K. Gusak Institute of Urgent and Reconstructive Surgery within the Ukrainian National Academy of Medical Sciences, Hematology Department, Donetsk 83045, Ukraine

Kyiv City Clinical Hospital #9, City Scientific-Practical Center for Diagnostics and Treatment of Patients with Hemostatic Pathlogies, Kiev 79044, Ukraine

State Institution "Institute of Blood Pathology and Transfusion Medicine within the Ukrainian National Academy of Medical Sciences", Hematology Department, Lviv, Ukraine

Health Point Medical Group "St Joseph's Children's Hospital", Tampa, Florida 33607, United States

Additional Information

Starting date: February 2013
Last updated: June 26, 2015

Page last updated: August 23, 2015

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