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A Gene Therapy Study for Hemophilia B

Last updated on February 20, 2019

FOR MORE INFORMATION
Study Location
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817 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 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Able to provide informed consent and comply with requirements of the study

- Males ≥18 y.o. with confirmed diagnosis of hemophilia B (≤2 IU/dL or ≤2% endogenous
factor IX)

- Received ≥50 exposure days to factor IX products

- A minimum average of 4 bleeding events per year requiring episodic treatment of factor
IX infusions or prophylactic factor IX infusions

- No measurable factor IX inhibitor as assessed by the central laboratory and have no
prior history of inhibitors to factor IX protein

- Agree to use reliable barrier contraception until 3 consecutive samples are negative
for vector sequences

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

- Evidence of active hepatitis B or C

- Currently on antiviral therapy for hepatitis B or C

- Have significant underlying liver disease

- Have serological evidence* of HIV-1 or HIV-2 with CD4 counts ?200/mm3 (* subjects who
are HIV+ and stable with CD4 count >200/mm3 and undetectable viral load are eligible
to enroll)

- Have detectable antibodies reactive with AAV-Spark100

- Participated in a gene transfer trial within the last 52 weeks or in a clinical trial
with an investigational drug within the last 12 weeks

- Unable or unwilling to comply with study assessments

NCT02484092
Pfizer
Active, not recruiting
A Gene Therapy Study for Hemophilia B

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now