NCT03161626

Registry Study of COAGADEX® Patients With Moderate or Severe Hereditary Factor X Deficiency Undergoing Major Surgery

A Multicenter, Post-Marketing Registry Study of COAGADEX® in the Peri-operative Management of Patients With Moderate or Severe Hereditary Factor X Deficiency Undergoing Major Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3 (actual)
• Sponsor: Bio Products Laboratory · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a non-interventional, multicenter, post-marketing registry study in three patients with moderate or severe hereditary FX deficiency, to assess Coagadex administered peri-operatively for hemostatic cover in major surgery during routine post-marketing use.

Detailed description

The primary objective is to collect additional surgical data on the clinical effectiveness of Coagadex, in a post-marketing environment, for peri-operative hemostatic cover during major surgery in patients with moderate or severe hereditary factor X (FX) deficiency. The secondary objective is to review safety data on Coagadex through the collection of any Adverse Drug Reactions (ADRs) from the first dose of Coagadex in the hospital prior to the surgical procedure until the first follow-up after discharge (i.e., follow-up completed) and Serious ADRs up until the post-operative care follow-up has been completed. Data on any deaths and pregnancies reported within this time period will be collected.

Conditions

• Factor 10 Deficiency

Interventions

Type	Name	Description
DRUG	Coagadex	Plasma-driven blood coagulation factor X concentration

Timeline

• Start date: 2018-02-27
• Primary completion: 2021-10-13
• Completion: 2021-10-13
• First posted: 2017-05-22
• Last updated: 2021-11-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study