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A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B

Last updated on July 16, 2019

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Study Location
Mississippi Center for Advanced Medicine
Madison, Mississippi, 39110 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia B
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Males who completed 6 months of routine Factor IX prophylaxis therapy during the lead
in study (C0371004) and have > = 50 documented exposure days to a FIX protein product
such as recombinant, plasma-derived or extended half-life FIX product

- Moderately severe to severe hemophilia B (Factor IX activity

- Suspension of prophylaxis therapy for hemophilia B after administration of the study
drug

- Laboratory values (hemoglobin, platelets and creatinine) within study specified limits

- Agree to contraception until components of the drug are eliminated from their body

- Capable of giving signed informed consent

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Anti-AAV Spark100 neutralizing antibodies (nAb) titer, above the established threshold
of 1:1

- History of inhibitor to Factor IX or inhibitor detected during screening.

- Clinical signs or symptoms of decreased response to Factor IX

- Hypersensitivity to Factor IX replacement product or intravenous immunoglobulin
administration

- History of chronic infection or other chronic disease

- Any concurrent clinically significant major disease or condition

- Laboratory values at screening visit that are abnormal or outside acceptable study
limits

- Significant and/or unstable liver disease, biliary disease, significant liver fibrosis

- Planned surgical procedure requiring Factor IX surgical prophylactic factor treatment
12 months from screening visit

- Use of restricted therapies (e.g., blood products, acetylsalicylic acid [aspirin] or
ibuprofen, other investigational therapy, and by-passing agents)

- Participation in a gene therapy research trial at any time or in an interventional
clinical study within 12 weeks of screening visit

- Active hepatitis B or C; hepatitis B surface antigen (HBsAg), hepatitis B virus (HBV)
deoxyribonucleic acid (DNA) positivity, or hepatitis C virus (HCV) ribonucleic acid
(RNA) positivity

- Serological evidence of human immunodeficiency virus HIV-1 or HIV-2 with Cluster of
Differentiation 4 positive (CD4+) cell count ?200 mm3 and/or viral load >20 copies/mL

- Study and sponsor staff and their families involved in the conduct of the study

- Unable to comply with study procedures

- Sensitivity to heparin or heparin induced thrombocytopenia

- Sensitivity to any of the study interventions, or components thereof, or drug or other
allergy

NCT03861273
Pfizer
Not yet recruiting
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B

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Pfizer Clinical Trials Contact Center

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[email protected]

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