Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan
- Registration Number
- NCT02042014
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
To provide continued treatment to Pulmonary Arterial Hypertension (PAH) patients who are benefitting from treatment with QTI571.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description QTI571 QTI571 Participants will receive QTI571 during 3 years.
- Primary Outcome Measures
Name Time Method Serious Adverse Events Approximately 2.9 years All Serious Adverse Events were evaluated and reported for all participants receiving QTI571. 16 individual SAEs were observed in 5 subjects.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Novartis Investigative Site
🇯🇵Mitaka-city, Tokyo, Japan