A post-authorization study to assess the safety and efficacy of Fanhdi (Double-inactivated human anti-hemophilic factor) in subjects with Von Willebrand disease (PostAuthorization Study with Fanhdi in VWD patient)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49679
• EU PAS number:
  EUPAS25809
• Study ID:
  49679
• Official title and acronym:
  A post-authorization study to assess the safety and efficacy of Fanhdi (Double-inactivated human anti-hemophilic factor) in subjects with Von Willebrand disease (PostAuthorization Study with Fanhdi in VWD patient)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Multicenter, observational, prospective, post-authorization cohort study done in subjects with von Willebrand disease.
• Study status:
  Finalised

Research institution and networks

Institutions

University Hospital Vall d’Hebron (HUVH)

Spain

Clinical Pharmacology, Vall d'Hebron Institut de Recerca (VHIR)

Spain

Hospital la Paz Madrid, Hospital Arnau de Vilanova Lleida, Hospital Carlos Haya Málaga, Hospital Virgen del Rocío Sevilla, Complejo Hospitalario de Jaén Jaén, Hospital de Guadalajara Guadalajara, Hospital Santa Creu i Sant Pau Barcelona

Study timelines

Date when funding contract was signed

Planned: 31/10/2018

Actual: 31/10/2018

Study start date

Planned: 15/02/2019

Actual: 20/03/2019

Data analysis start date

Planned: 26/05/2022

Date of final study report

Planned: 28/02/2023

Actual: 09/03/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Instituto Grifols, S.A.

Study protocol

Initial protocol

IG1403 Protocol V3.0 2018.05.18

Updated protocol

Protocolo v 4.0 (2021_01_20)_redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable