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A Study of Recombinant AAV2/6 Human Factor 8 Gene Therapy SB-525 (PF-07055480) in Subjects With Severe Hemophilia A
A Study of Recombinant AAV2/6 Human Factor 8 Gene Therapy SB-525 (PF-07055480) in Subjects With Severe Hemophilia A

NCT03061201

CompletedPhase 2

Sponsor: Pfizer

Conditions: Hemophilia A

Interventions: SB-525 (PF-07055480)

Countries: United States

The purpose of the study is to evaluate the safety, tolerability and time-course profile of FVIII activity after dosing with SB-525 (PF-07055480)

Eligibility overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Male ≥18 years of age
* Severe hemophilia A (past evidence of circulating FVIII activity of \< 1% normal)
* Treated or exposed to FVIII concentrates or cryoprecipitate for at least 150 exposure days
* ≥12 bleeding episodes if receiving on-demand therapy over the preceding 12 months
* Agree to use double barrier contraceptive until at least 3 consecutive semen samples are negative for AAV 2/6 after SB-525 infusion

Exclusion Criteria:

* Presence of neutralizing antibodies
* Current inhibitor, or history of FVIII inhibitor (except for transient low titer inhibitor detected in childhood)
* History of hypersensitivity response to FVIII
* History of Hepatitis B or HIV-1/2 infection
* History of Hepatitis C, unless viral assays in two samples, collected at least 6 months apart, are negative
* Evidence of any bleeding disorder in addition to hemophilia A
* Markers of hepatic inflammation or overt or occult cirrhosis
* History of chronic renal disease or creatinine ≥ 1.5 mg/dL
* Presence of liver mass on magnetic resonance imaging (MRI), or, positive alpha fetoprotein
* Presence of \> grade 2 liver fibrosis on elastography for subjects with history of treated Hepatitis C or suspicion of chronic liver disease
Locations (22)
  • Little Rock, Arkansas, United States
  • Duarte, California, United States
  • Sacramento, California, United States
  • Sacramento, California, United States
  • Sacramento, California, United States
  • Sacramento, California, United States
  • Sacramento, California, United States
  • Sacramento, California, United States
  • Sacramento, California, United States
  • San Francisco, California, United States
  • San Francisco, California, United States
  • San Francisco, California, United States
  • Miami, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Pittsburgh, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Nashville, Tennessee, United States
  • Nashville, Tennessee, United States
  • Nashville, Tennessee, United States
  • Seattle, Washington, United States