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

Last updated on December 8, 2018

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. 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.
Show details

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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Long-term Safety and Efficacy Study of SPK-9001 in Individuals With Hemophilia B
FIX-LONG Study: A Factor IX (FIX) Gene Transfer, Multi-center Evaluation of the LONG-term Safety and Efficacy Study of SPK-9001 (rAAV-Spark100-hFIX-Padua) in Individuals With Hemophilia B
Long-term safety follow-up for subjects with Hemophilia B and previously treated in the SPK-9001-101 protocol
Evaluation of the long term level of persistence and potential late or delayed adverse events associated with SPK-9001, assessment of the durability of the transgene expression, and determination of the effects of SPK-9001 on clinical outcomes in individuals who have previously received a single administration of SPK-9001
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Subjects with Hemophilia B and previously treated in the SPK-9001-101 protocol
Hemophilia B
Biological: SPK-9001
Observational long-term safety follow-up study of subjects previously treated in the SPK-9001-101 protocol
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
11
April 30, 2023
April 30, 2023   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  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:

  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.
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Genetic males
18 Years and older   (Adult, Older Adult)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Australia,   United States
 
 
NCT03307980
C0371003
SPK-9001-LTFU-101 ( Other Identifier: Sparks Therapeutics )
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2018

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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