You are here

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

Last updated on August 15, 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.
Show details

1. Evidence of a personally signed and dated informed consent document indicating that
the subject has been informed of all pertinent aspects of the study.

2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests,
and other study procedures.

3. Subjects who met the C0371005 eligibility criteria, have received a single
administration of SPK-9001, and completed the required assessments in the C0371005
clinical study.

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

1. Investigator site staff members directly involved in the conduct of the study and
their family members, site staff members otherwise supervised by the investigator, or
subjects who are Pfizer employees, including their family members, directly involved
in the conduct of the study.

2. Participation in other studies involving investigational drug(s) within the last 12
weeks prior to study entry, excluding participation in C0371005, and/or during study
participation.

3. Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the subject inappropriate for entry into this
study.

4. Fertile male subjects who are unwilling or unable to use a condom as outlined in this
protocol until 3 consecutive semen samples are negative in the vector shedding
analysis after the last dose of investigational product.

5. Subjects who will not consent for up to 5 years of safety follow-up.

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

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

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

NEED INFO?

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

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

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