A Prospective, Non-interventional, Observational Post-authorisation Study to Assess the Late-effects of Patients who have received Unituxin (ALIVIO)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/17796
• EU PAS number:
  EUPAS14095
• Study ID:
  17796
• Official title and acronym:
  A Prospective, Non-interventional, Observational Post-authorisation Study to Assess the Late-effects of Patients who have received Unituxin (ALIVIO)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Netherlands

  Norway

  Spain

  United Kingdom
• Study description:
  Following assessment of the global availability of Unituxin, UTC has decided to terminate the trial due to significant short and intermediate-term drug supply shortages. The study has been terminated on 15 December 2016. Please also note, no data was collected as per section 3, only planned dates have been populated in the actual dates field due to restrictions on the form.
• Study status:
  Finalised

Research institution and networks

Institutions

United BioSource Corporation (UBC)

Switzerland

Multiple centres: 40 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 28/04/2016

Study start date

Planned: 02/01/2017

Actual: 15/12/2016

Date of final study report

Planned: 11/03/2030

Actual: 15/12/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

United Therapeutics Corporation (UTC)

Study protocol

Initial protocol

DIV-NB-402 Final Protocol Version 2.0_16Aug2016

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)