A Study to Evaluate the Efficacy and Safety of Factor IX …

Posted: May 26, 2019 at 9:48 am

ClinicalTrials.gov Identifier: NCT03861273 Recruitment Status : Not yet recruiting

First Posted : March 4, 2019

Last Update Posted : April 4, 2019

Sponsor:

Information provided by (Responsible Party):

Pfizer

Brief Summary:

This study will evaluate the efficacy and safety of PF-06838435 (a gene therapy drug) in adult male participants with moderately severe to severe hemophilia B (participants that have a Factor IX circulating activity of 2% or less). The gene therapy is designed to introduce genetic material into cells to compensate for missing or non-functioning Factor IX. Eligible study participants will have completed a minimum 6 months of routine Factor IX prophylaxis therapy during the lead in study (C0371004). Participants will be dosed once (intravenously) and will be evaluated over the course of 6 years. The main objectives of the study are to compare the annualized bleeding rate [ABR] of the gene therapy to routine prophylaxis from the lead-in study and to evaluate the impact that it may have on participant's Factor IX circulating activity [FIX:C].

Gene Therapy

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Inclusion Criteria

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03861273

Pfizer

Read the original here:
A Study to Evaluate the Efficacy and Safety of Factor IX ...

Related Post

Comments are closed.

Archives