Back to resultsOpen-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan
Primary Purpose
Severe Pulmonary Arterial Hypertension
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
QTI571
Sponsored by
About this trial
This is an interventional treatment trial for Severe Pulmonary Arterial Hypertension focused on measuring Pulmonary arterial hypertension, QTI571, open label study
Eligibility Criteria
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.
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
QTI571
Arm Description
Participants will receive QTI571 during 3 years.
Outcomes
Primary Outcome Measures
Serious Adverse Events
All Serious Adverse Events were evaluated and reported for all participants receiving QTI571. 16 individual SAEs were observed in 5 subjects.
Secondary Outcome Measures
Full Information
NCT ID
NCT02042014
First Posted
January 17, 2014
Last Updated
June 17, 2019
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02042014
Brief Title
Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan
Official Title
An Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan and Are Judged by the Investigator to Benefit From Continued QTI571 Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 22, 2014 (Actual)
Primary Completion Date
October 17, 2016 (Actual)
Study Completion Date
October 17, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Pulmonary Arterial Hypertension
Keywords
Pulmonary arterial hypertension, QTI571, open label study
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model 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
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
QTI571
Arm Type
Experimental
Arm Description
Participants will receive QTI571 during 3 years.
Intervention Type
Drug
Intervention Name(s)
QTI571
Intervention Description
QTI571 200mg up to 400mg (depending on tolerability) taken orally, once a day.
Primary Outcome Measure Information:
Title
Serious Adverse Events
Description
All Serious Adverse Events were evaluated and reported for all participants receiving QTI571. 16 individual SAEs were observed in 5 subjects.
Time Frame
Approximately 2.9 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Novartis Investigative Site
City
Sendai-city
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Novartis Investigative Site
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
Facility Name
Novartis Investigative Site
City
Mitaka-city
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Learn more about this trial
Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan
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