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COMPLETED
NCT03938792
PHASE3

Study of the Efficacy and Safety PF-06741086 in Adult and Teenage Participants With Severe Hemophilia A or Moderately Severe to Severe Hemophilia B

Sponsor: Pfizer

View on ClinicalTrials.gov

Summary

Treatment with PF-06741086 is anticipated to demonstrate a clinically relevant advantage and/or a major contribution to patient care in comparison to current methods of treatment for hemophilia A or B because it works differently than factor replacement products and will work in the presence of inhibitors. The potential for once weekly (QW) subcutaneous (SC) administration provides for treatment options in the absence of reliable vascular access, increased convenience and may enable better compliance. Combined, these qualities should result in a reduction of bleeding episodes.

Official title: An Open-Label Study in Adolescent and Adult Severe (Coagulation Factor Activity <1%) Hemophilia A Participants With or Without Inhibitors or Moderately Severe to Severe Hemophilia B Participants (Coagulation Factor Activity ≤2%) With or Without Inhibitors Comparing Standard Treatment to PF-06741086 Prophylaxis

Key Details

Gender

MALE

Age Range

12 Years - 74 Years

Study Type

INTERVENTIONAL

Enrollment

188

Start Date

2020-03-09

Completion Date

2025-04-29

Last Updated

2026-08-14

Healthy Volunteers

No

Interventions

DRUG

PF-06741086

300 milligrams(mg) subcutaneous (sc) loading dose followed by 150 mg sq once weekly (qw). 300 mg sc qw is prescribed for participants who meet dose escalation criteria.

Locations (62)

USF Health Morsani Center For Advanced Healthcare

Tampa, Florida, United States

University of Iowa

Iowa City, Iowa, United States

Northwell Health HTC

New Hyde Park, New York, United States

Washington Institute for Coagulation

Seattle, Washington, United States

National Specialized Hospital for the Active Treatment of Hematological Diseases - EAD, Sofia

Sofia, Bulgaria

UMHAT "Prof.Dr. Stoyan Kirkovich"

Stara Zagora, Bulgaria

McMaster University Medical Centre - Hamilton Health Sciences

Hamilton, Ontario, Canada

McMaster Children's Hospital

Hamilton, Ontario, Canada

McMaster University

Hamilton, Ontario, Canada

The Hospital For Sick Children

Toronto, Ontario, Canada

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

Institute of Hematology, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Beijing Children's Hospital, Capital Medical University

Beijing, China

Klinicki bolnicki centar Zagreb

Zagreb, Croatia

Hôpital Necker Enfants Malades

Paris, France

Prince of Wales Hospital

Hong Kong, Hong Kong

Queen Mary Hospital

Hong Kong, Hong Kong

Nirmal Hospital Pvt, Ltd

Surat, Gujarat, India

Sahyadri Clinical Research and Development Center

Pune, Maharashtra, India

Sahyadri Super Speciality Hospital

Pune, Maharashtra, India

Christian Medical College

Vellore, Tamil Nadu, India

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Milan, Italy

Università degli Studi di Roma "Sapienza"-Policlinico Umberto I

Roma, RM, Italy

Università degli Studi di Perugia, Azienda Ospedaliera di Perugia, Ospedale Santa Maria della

Perugia, Italy

Nagoya University Hospital - Transfusion Medicine

Nagoya, Aichi-ken, Japan

Sapporo Tokushukai Hospital

Sapporo, Hokkaido, Japan

Saitama Medical University Hospital

Iruma-gun, Saitama, Japan

Hiroshima University Hospital

Hiroshima, Japan

Hospital Universitario "Dr Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, Mexico

Centro Multidisciplinario para el Desarrollo Especializado de la Inv. Clínica en Yucatán, S.C.P.

Mérida, Yucatán, Mexico

Sultan Qaboos University Hospital

Muscat, Oman

FGBOU VO "Samara State Medical University" of MoH of Russia

Samara, Russia

King Abdulaziz University Hospital

Jeddah, Saudi Arabia

King Faisal Specialist Hospital & Research Center

Riyadh, Saudi Arabia

Clinical Center of Serbia

Belgrade, Serbia

Institute for Mother and Child healthcare "Dr Vukan Cupic"

Belgrade, Serbia

Clinical Center Kragujevac

Kragujevac, Serbia

Clinical Center Nis

Niš, Serbia

Charlotte Maxeke Johannesburg Academic Hospital

Johannesburg, Gauteng, South Africa

Kyungpook National University Hospital

Daegu, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Kyung Hee University Hospital At Gangdong

Seoul, South Korea

Hospital Universitario A Coruna

A Coruña, Spain

Hospital Universitario Vall d´Hebron

Barcelona, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario de Salamanca

Salamanca, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

ChangHua Christian Hospital

Changhua, Changhua County, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Acibadem Adana Hospital

Adana, Turkey (Türkiye)

Hacettepe University Medical Faculty

Ankara, Turkey (Türkiye)

Gazi University Health Research and Practice Center Gazi Hospital

Ankara, Turkey (Türkiye)

Akdeniz University Medical Faculty

Antalya, Turkey (Türkiye)

Gaziantep University Sahinbey Research and Training Hospital

Gaziantep, Turkey (Türkiye)

Istanbul University Oncology Institute

Istanbul, Turkey (Türkiye)

Ege University Medical Faculty

Izmir, Turkey (Türkiye)

Dr. Behcet Uz Child Diseases Surgery Education and Research Hospital

Izmir, Turkey (Türkiye)

Erciyes University Medical Faculty

Kayseri, Turkey (Türkiye)

Ondokuz Mayıs University Medical Faculty

Samsun, Turkey (Türkiye)

Karadeniz Technical University Medical Faculty

Trabzon, Turkey (Türkiye)