Use, safety and Tolerability of IntraVenous epOprostenoL (Veletri®) in patients with severe pulmonary arterIal hypertension: A 6-month, open label, multicenter,observational, non-interventional study (TIVOLI)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45989
• EU PAS number:
  EUPAS32492
• Study ID:
  45989
• Official title and acronym:
  Use, safety and Tolerability of IntraVenous epOprostenoL (Veletri®) in patients with severe pulmonary arterIal hypertension: A 6-month, open label, multicenter,observational, non-interventional study (TIVOLI)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  This was a non-interventional, observational and prospective, multicenter study to evaluate the use, safety and tolerability of i.v. epoprostenol therapy (Veletri®) in routine practice according to the German Drug Law (AMG, §67(6)). Patients with invasively diagnosed PAH receiving targeted PAH combination treatment in need of treatment escalation with i.v. epoprostenol, according to medically indicated decision on treatment-escalation, were included in this non-interventional, observational study. This study was performed as a non-interventional trial using a prospective, open label, multicenter clinical study design with treatment according to current medical practice. Patients were assessed according to routine clinical examinations in their respective pulmonary hypertension expert center. According to the current guidelines, patients were seen in the expert center about every three months. This allowed to collect data within the first 6 months of treatment and compare changes between baseline, 3 and 6 months (~24 weeks). Routine medical examinations comprised of medical history, physical examination, electrocardiogram (ECG), laboratory testing (including NT-proBNP), echocardiography at rest, and right heart catheterization according to clinical practice of the PH center. When patients fulfilled the inclusion criteria they were invited to join the study. The prospective period of data collection comprised of a ~24-week study period and a follow-up phase of about 30±7 days. Outcome (survival and transplant-free survival) of all patients was assessed when the last patient terminated his/her ~24 week observation period.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Actual: 03/11/2017

Study start date

Actual: 27/03/2018

Data analysis start date

Planned: 01/04/2021

Actual: 01/04/2021

Date of final study report

Planned: 05/03/2022

Actual: 25/02/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Actelion / Johnson & Johnson

Study protocol

Initial protocol

2018-05-03 Observational trial Protocol Veletri_V 1.2

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

BfArM NIS 7185