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Evaluate Real-World Use of Next Generation Infusion Pumps to Administer Remodulin

Sponsored by United Therapeutics

About this trial

Last updated 2 years ago

Study ID

REM-PH-417

Status

Recruiting

Type

Observational

Placebo

No

Accepting

18-75 Years
22+ Years
All
All

Trial Timing

Ended a year ago

What is this trial about?

To observe and assess drug administration activities, time spent on drug administration activities, and patient-reported outcomes (PROs) including quality of life, treatment satisfaction, and patient perception of devices related to use of United Therapeutics Corporation (UTC)-developed next-generation infusion pumps to administer Remodulin in patients with Pulmonary Arterial Hypertension (PAH).

What are the Participation Requirements?

Inclusion Criteria - De Novo Cohort:

1. The patient is greater than 22 years of age at time of providing informed consent.

2. The patient is willing and able to provide informed consent and has the ability to
answer surveys, questionnaires, and use the diary in English.

3. The patient has received a referral for SC Remodulin via Remunity Pump for Remodulin
(treprostinil) Injection or has started SC Remodulin via Remunity Pump for Remodulin
(treprostinil) Injection within 10 days prior to providing informed consent.

4. The patient has not been previously treated with a parenteral prostacyclin-class
therapy in the past 30 days prior to providing informed consent, except in cases where
patient initiates in patient parenteral prostacyclin-class therapy via another
infusion pump with orders to start SC Remodulin therapy with the Remunity Pump for
Remodulin (treprostinil) Injection upon discharge.

Inclusion Criteria - Transition Cohort:

1. The patient is greater than 22 years of age at time of providing informed consent.

2. The patient is willing and able to provide informed consent and has the ability to
answer surveys, questionnaires, and use the diary in English.

3. The patient has received a referral for SC Remodulin via Remunity Pump for Remodulin
(treprostinil) Injection or has started SC Remodulin via Remunity Pump for Remodulin
(treprostinil) Injection within 10 days prior to providing informed consent.

4. The patient had been receiving continuous infusion of SC treprostinil via an infusion
pump other than Remunity for at least 60 days prior to providing informed consent and
is at a dose of at least 10 ng/kg/min with no change in dose for at least 21 days
prior to providing informed consent.

Exclusion Criteria:

1. The patient is pregnant, trying to become pregnant, or lactating.

2. For those in the Transition Cohort: The patient has a history of adverse events
resulting from interruptions in their treprostinil infusions over relatively short
periods (such as less than 8 hours) as they may be at higher risk in the event of pump
failure, especially at night.

3. The patient is enrolled in, has participated within the last 30 days, or is planning
to participate in an interventional study. Note: co-enrollment in other observational
studies is permitted.

4. For those in the Transition Cohort: The patient is receiving parenteral treprostinil
via IV administration.

Locations

Location

Status

Recruiting