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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-22

Study Completion Date

2016-10-17

Brief Summary

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

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Detailed Description

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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.

Conditions

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Severe Pulmonary Arterial Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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QTI571

Participants will receive QTI571 during 3 years.

Group Type EXPERIMENTAL

QTI571

Intervention Type DRUG

QTI571 200mg up to 400mg (depending on tolerability) taken orally, once a day.

Interventions

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QTI571

QTI571 200mg up to 400mg (depending on tolerability) taken orally, once a day.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No