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Long-term Safety and Efficacy Study of SPK-9001 in Individuals With Hemophilia B

Last updated on February 16, 2019

FOR MORE INFORMATION
Study Location
UC Davis Midtown Clinic
Sacramento, California, 95816 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.
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1. Ability to understand the purpose and risks of the study, as well as provide signed
and dated informed consent and authorization to use protected health information (PHI)
in accordance with national and local study participant privacy regulations.

2. Subjects who have received a single administration of SPK-9001, and completed the
required assessments in the SPK-9001-101 clinical study.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. Subjects who will not consent for up to 5 years of safety follow-up.

2. Subjects who are unable or unwilling to comply with the study visits and requirements.

3. Subjects who have planned to participate in another interventional investigational
gene transfer study.

4. Subjects with any clinically significant medical condition that the Investigator
believes would pose as a safety risk or are not capable of the performing endpoints of
this study.

NCT03307980
Pfizer
Recruiting
Long-term Safety and Efficacy Study of SPK-9001 in Individuals With Hemophilia B

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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