Clinical Trial for Hemophilia B. | Pfizer

This study will evaluate the efficacy and safety of PF-06838435 (a gene therapy drug) in adult male participants with moderately severe to severe hemophilia B (participants that have a Factor IX circulating activity of 2% or less). The gene therapy is designed to introduce genetic material into cells to compensate for missing or non-functioning Factor IX. Eligible study participants will have completed a minimum 6 months of routine Factor IX prophylaxis therapy during the lead in study (C0371004). Participants will be dosed once (intravenously) and will be evaluated over the course of 6 years. The main objective of the study will evaluate the annualized bleeding rate \[ABR\] for participants treated with gene therapy versus standard of care (SOC) therapy (FIX prophylaxis replacement regimen).

Closest Location

To find study locations, use the location search box below.

Who may participate

Each clinical study has its own guidelines for who may participate, called eligibility criteria. These factors can include your age, sex, overall health, type and stage of disease, and personal treatment history. However, only the research study staff can determine if you qualify to enroll in the study.

Condition

Hemophilia B

Sex

Male

Age

18 - 65 years

View more eligibility criteria on ClinicalTrials.gov

Study Locations

Location

Distance

Center for Human Phenomic Science CHPS

Philadelphia, Pennsylvania, United States, 19104

Recruiting

80.5 mi

Center for Human Phenomic Science

Philadelphia, Pennsylvania, United States, 19104

Recruiting

80.5 mi

Investigational Drug Service

Philadelphia, Pennsylvania, United States, 19104

Recruiting

80.5 mi

Penn Blood Disorder Center

Philadelphia, Pennsylvania, United States, 19104

Recruiting

80.5 mi

St. Michael's Hospital

Toronto, Ontario, Canada, M5B 1W8

Recruiting

345.3 mi

McMaster University Medical Centre - Hamilton Health Sciences

Hamilton, Ontario, Canada, L8N 3Z5

Recruiting

347.5 mi

Juravinski Hospital - Hamilton Health Sciences

Hamilton, Ontario, Canada, L8V 1C3

Recruiting

347.5 mi

Indiana Hemophilia & Thrombosis Center, Inc.

Indianapolis, Indiana, United States, 46260

Recruiting

643.7 mi

Indiana Hemophilia and Thrombosis Center, Inc

Indianapolis, Indiana, United States, 46260

Recruiting

643.7 mi

St. Vincent Hospital & Health Care Center, Inc.

Indianapolis, Indiana, United States, 46260

Recruiting

643.7 mi

Madison Radiological Group

Madison, Mississippi, United States, 39110

Recruiting

1057.5 mi

Mississippi Center for Advanced Medicine

Madison, Mississippi, United States, 39110

Recruiting

1057.5 mi

Hemophilia and Thrombosis Center at the University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Recruiting

1619.4 mi

University of California, San Francisco - Clinical Research Center

San Francisco, California, United States, 94143

Recruiting

2565.9 mi

University of California, San Francisco - Outpatient Hematology Clinic

San Francisco, California, United States, 94143

Recruiting

2565.9 mi

Glasgow Royal Infirmary

Glasgow, United Kingdom, G4 0SF

Recruiting

3219.8 mi

Glasgow Royal Infirmary

Glasgow, United Kingdom, G4 0SF

Not yet recruiting

3219.8 mi

Newcastle upon Tyne Hospitals NHS FT

Newcastle Upon Tyne, Tyne & Wear, United Kingdom, NE1 4LP

Recruiting

3334.7 mi

Newcastle upon Tyne Hospitals NHS FT

Newcastle Upon Tyne, Tyne & Wear, United Kingdom, NE1 4LP

Not yet recruiting

3334.7 mi

Newcastle upon Tyne Hospitals NHS FT

Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE2 4HH

Recruiting

3334.7 mi

Newcastle upon Tyne Hospitals NHS FT

Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE2 4HH

Not yet recruiting

3334.7 mi

Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, United Kingdom, NE2 4HH

Not yet recruiting

3334.7 mi

Hopital Necker

Paris, France, 75015

Recruiting

3627.3 mi

Universitätsklinikum Bonn, Anstalt des öffentlichen Rechts

Bonn, Germany, 53127

Recruiting

3773.1 mi

Universitätsklinikum Bonn

Bonn, Germany, 53127

Recruiting

3773.1 mi

Hopital Cardiologique Louis Pradel - CRTH

Bron, France, 69677

Recruiting

3823.7 mi

Skåne University Hospital, Department of Hematology, Oncology and Radiation Physics

Malmö, Sweden, 205 02

Recruiting

3862.8 mi

ApoEx AB

Malmö, Sweden, 211 24

Recruiting

3862.8 mi

Vivantes Klinikum Friedrichshain

Berlin, Germany, 10249

Recruiting

3967.8 mi

Vivantes Klinikum im Friedrichshain

Berlin, Germany, 10249

Recruiting

3967.8 mi

Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP

Campinas, SÃO Paulo, Brazil, 13083-878

Recruiting

4724.5 mi

Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti - HEMORIO

Rio de Janeiro, Brazil, 20211-030

Recruiting

4820.4 mi

Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti- HEMORIO

Rio de Janeiro, Brazil, 20211-030

Recruiting

4820.4 mi

General Hospital of Athens "LAIKO", 2nd Regional Blood Transfusion Center

Athens, Greece, 11527

Recruiting

4924.6 mi

Istanbul University Oncology Institute

Istanbul, Turkey, 34093

Recruiting

5013.3 mi

Ege University Medical Faculty Hospital

Izmir, Turkey, 35040

Recruiting

5052 mi

Acibadem Adana Hospital

Adana, Turkey, 01130

Recruiting

5453.4 mi

Gaziantep University Sahinbey Training and Research Hospital

Gaziantep, Turkey, 27310

Recruiting

5532.5 mi

Sapporo Tokushukai Hospital

Sapporo, Hokkaido, Japan, 004-0041

Recruiting

6243.4 mi

King Faisal Specialist Hospital and Research Centre

Riyadh, Saudi Arabia

Recruiting

6533.7 mi

Saitama Medical University Hospital

Iruma-gun, Saitama, Japan, 350-0495

Recruiting

6735 mi

National Center for Child Health and Development

Setagaya-ku, Tokyo, Japan, 157-8535

Recruiting

6745 mi

Kyung Hee University Hospital at Gangdong

Seoul, Korea, Republic of, 05278

Not yet recruiting

6868.2 mi

National Taiwan University Hospital

Taipei, Taiwan, 10002

Recruiting

7785.4 mi

Chung Shan Medical University Hospital

Taichung City, Taiwan, 40201

Not yet recruiting

7857.6 mi

Chung Shan Medical University

Taichung City, Taiwan, 40201

Not yet recruiting

7857.6 mi

Taichung Veterans General Hospital

Taichung, Taiwan, 40705

Recruiting

7857.6 mi

Changhua Christian Hospital

Changhua, Taiwan, 500

Recruiting

7864.2 mi

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, 807

Recruiting

7965.9 mi

Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia, 4029

Not yet recruiting

9632 mi

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia, 2050

Recruiting

9937.9 mi

The Alfred Hospital

Melbourne, Victoria, Australia, 3004

Recruiting

10360.3 mi

Royal Adelaide Hospital

Adelaide, South Australia, Australia, 5000

Recruiting

10624.7 mi

Fiona Stanley Hospital

Murdoch, Western Australia, Australia, 6150

Recruiting

11628.4 mi