A Low-Interventional Multicentre Post-Authorisation Safety Study for Voncento / Biostate / Aleviate for Routine Prophylaxis, Treatment of Bleeding Events and / or Surgery in Male Subjects with Haemophilia A (Biostate_4001)

Study identification

• EU PAS number:
  EUPAS19806
• Study ID:
  34657
• Official title and acronym:
  A Low-Interventional Multicentre Post-Authorisation Safety Study for Voncento / Biostate / Aleviate for Routine Prophylaxis, Treatment of Bleeding Events and / or Surgery in Male Subjects with Haemophilia A (Biostate_4001)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Hong Kong
• Study description:
  This is a multicentre, open-label, single-arm, phase 4, low-interventional PASS study. It is planned to evaluate the combined safety data from this post-marketing study during a 5-year accrual period, and from disease registries (EUHASS) to reach a target of approximately 100 patients. This is a prospective study in subjects with haemophilia A to investigate the safety of Voncento as used for the treatment of acute bleeding episodes, routine prophylaxis, and / or perioperative bleeding in these subjects. Eligible subjects will have haemophilia A and be known to have been exposed to FVIII-containing products for at least 150 exposure days. Enrolled subjects will be treated with Voncento at participating study centres at the discretion of the PI according to current local practice, and will be followed for approximately 100 EDs.This study was never activated and no subjects were enrolled.
• Study status:
  Finalised

Research institutions and networks

Institutions

CSL Behring

Moerfelden-Walldorf HZRM Moerfelden-Walldorf, Germany, Princess Margaret Hospital Hong Kong

Study timelines

Date when funding contract was signed

Planned:15/08/2016

Actual:15/08/2016

Study start date

Planned:03/02/2020

Actual:31/03/2020

Date of final study report

Planned:21/07/2023

Actual:31/03/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

CSL Behring

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)