Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02889315 |
| Other study ID # |
001 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 2013 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
August 2021 |
| Source |
Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med |
| Contact |
Marcin Kurzyna, MD,PhD |
| Phone |
+48-22-7103052 |
| Email |
marcin.kurzyna[@]ecz-otwock.pl |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Subcutaneous treprostinil is used to treat pulmonary arterial hypertension (PAH). Due to
local pain it causes a deterioration of quality of life or even abandonment of treatment. The
aim of this study was to evaluate the safety and quality of life (QoL) in patients treated
with treprostinil administration using an implantable Lenus Pro® pump. This is a
observational study involving patients with PAH treated with a subcutaneous infusion of
treprostinil with intolerable pain at the infusion site, who were therefore referred for pump
implantation. Clinical evaluation, including QoL assessment with SF-36 questionnaire was
performed at the time of initiating therapy with treprostinil, before and 2-9 months after
implantation.
Description:
Treprostinil is a prostacyclin analogue, a drug that is widely used to treat pulmonary
arterial hypertension (PAH). Its efficacy was confirmed in studies that compared it to
placebo and to epoprostenol. Due to stability of treprostinil sodium solution and its
relatively long (when compared to prostacyclin) half-life, the drug enabled PAH patients to
receive safe long-term treatment. It is administered as a continuous subcutaneous infusion
using an insulin pump. In the case of this route of administration, its half-life is about 3
hours. Unfortunately, due to reaction at the infusion site many patients report significant
deterioration of quality of life, and some of them (about 5-10%) even abandon treatment .
There are trials in progress to find a more convenient method of administration for this
drug. The efficacy of oral administration has been uncertain - reports are contradictory,
while inhalations remain a valid alternative for patients in a less advanced stage of the
disease. Therefore, for patients whose illness is more severe, only continuous parenteral
administration of the drug remains an option.
The Lenus Pro® implantable pump appears to be a promising alternative to an external pump. By
means of this method, treprostinil sodium is administered as a continuous intravenous
infusion, and the drug reservoir is refilled every 28 days. Thermal stability of treprostinil
at body temperature was confirmed during a 60-day observation; concentrations of the drug
administered intravenously are comparable to subcutaneous administration, and the only
differing parameter is a shorter half-life of less than 1 hour. The first experiences with
implantable pumps originate in Austria and Germany and present this method of treatment as a
milestone in PAH therapy. In Poland, the first implantation of a Lenus Pro® pump took place
in 2013 (18).
The aim of this study is an analysis of efficacy and safety of treatment with intravenous
treprostinil administered by means of the Lenus Pro® implantable pump.
Prior to pump implantation the subcutaneous dose of treprostinil is escalated up to the
highest dose tolerated by a particular patient. The procedure of pump implantation is carried
out under general anaesthesia Clinical and haemodynamic evaluation is performed at the time
of initiating PAH therapy with treprostinil. Right before and during 2-9 months after Lenus
Pro® pump implantation, non-invasive clinical evaluation was made, including: WHO functional
class, 6-minute walking test (6MWT), and concentration of NT-proBNP. Additionally patients
fill in the SF36 quality of life questionnaire before implantation and 2-9 months after
implantation.
