Study to Evaluate the Efficacy and Safety of PF-07055480 / Giroctocogene Fitelparvovec Gene Therapy in Moderately Severe to Severe Hemophilia A Adults

Study Identifier:
C3731003
ClinicalTrials.gov Identifier:
EudraCT Identifier:
Sponsor:
Pfizer
Collaborator:
N/A
Study Contact Information:
N/A
Unmapped

Study Details

Medical Condition
  • Hemophilia A
Study Drug
  • Biological: PF-07055480 (giroctocogene fitelparovec): Recombinant AAV2/6 Human Factor VIII Gene Therapy
Date
Aug 2020 - Jun 2024
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Male
Age: 18 - 64 Years years
Requirements Information

Protocol Summary

This study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected under the skin using a pen-injector either once every week, once every two weeks or once every month. The participants will be trained in using the pen injector. The participants can choose themselves, in collaboration with the study doctor how often they get Mim8 in this study. When the participant will get their first Mim8 injection depends on their current treatment with emicizumab. The participants will get their first Mim8 injection at Visit 2. Participants will have between 6 and 27 Mim8 injections. The total number of injections participants will have depends on their dosing frequency. The study will last for about 6-12 months. While taking part in this study, there are some restrictions about what medicine participant can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.

Trial Locations

Location
Status
Location
NOW Physical Therapy
Mountain View, California, United States, 94040
Status
N/A
Location
Clinical and Translational Research Unit (CTRU)
Palo Alto, California, United States, 94304
Status
N/A
Location
Lucile Packard Childrens Hospital
Palo Alto, California, United States, 94304
Status
N/A
Location
Imaging Clinic at Stanford Medicine Outpatient Center in Redwood City
Redwood City, California, United States, 94063
Status
N/A
Location
UCSF IDS Pharmacy
San Francisco, California, United States, 94143
Status
N/A
Location
University of California, San Francisco - Clinical Research Center
San Francisco, California, United States, 94143
Status
N/A