A Registry for Patients Taking Uptravi (SPHERE)

Actelion Pharmaceuticals

Status: Completed

Conditions: Pulmonary Arterial Hypertension

Study type: Observational

Funder types: Industry

Identifiers

NCT03278002

AC-065A402

Details and patient eligibility

About

This is a US multi-center, prospective, real world, observational drug registry enrolling patients actively treated with Uptravi. Participating patients will be followed prospectively for a maximum of 18 months from the date of enrollment into the registry.

Enrollment: 800 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed patient informed consent form (ICF).

• Patients ≥ 18 years of age at time of Uptravi initiation, and

• Patients who initiate Uptravi:

  • at enrollment, or
  • less than or equal to 60 days prior to enrollment and have a documented titration regimen (defined as all documented dose changes including, but not limited to: starting dose and dates and highest tolerated dose and dates)

Exclusion criteria

• Patients previously exposed to Uptravi treatment during a clinical trial.
• Patients that previously discontinued Uptravi for any reason, prior to study enrollment (discontinuation defined as an interruption of therapy greater than or equal to 30 days).
• Patients enrolled in a blinded clinical trial or in a clinical trial involving an unapproved drug.

Trial design

800 participants in 1 patient group

Group/Cohort Information

Description:

This is a US multi-center, prospective, real world, observational drug registry enrolling patients actively treated with Uptravi. Participating patients will be followed prospectively for a maximum of 18 months from the date of enrollment into the registry.