Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan

Novartis

Status and phase: Completed; Phase 3

Conditions: Severe Pulmonary Arterial Hypertension

Treatments: Drug: QTI571

Study type: Interventional

Funder types: Industry

Identifiers

NCT02042014

CQTI571AJP01

Details and patient eligibility

About

To provide continued treatment to Pulmonary Arterial Hypertension (PAH) patients who are benefitting from treatment with QTI571.

Full description

This was a multi-center open label study to provide continued supply of QTI571 to patients in Japan who were treated in the extension study (A2301E1) and were judged by the investigator to benefit from continued QTI571 treatment.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patient is receiving QTI571 for the treatment of Pulmonary Arterial Hypertension (PAH) and is currectly enrolled in a long-term extension study (CQTI571A2301E1) in Japan.
• Patient is currently benifitting form the treatment with QTI571 in the opinion of the investigator.

Exclusion criteria

• Patient has been permanently discontinued from QTI571 study treatment in the parent study.
• Concomitant use of oral vitamin K antagonist medication.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

QTI571

Experimental group

Description:

Participants will receive QTI571 during 3 years.

Treatment:

Drug: QTI571