Phase 3
Completed N=8
Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan
Severe Pulmonary Arterial Hypertension
Source: ClinicalTrials.gov NCT02042014 ↗
Enrolled (actual)
8
Serious AEs
62.5%
Results posted
Jun 2019
Primary outcomePrimary: Serious Adverse Events — 5; 3; 1; 1 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
To provide continued treatment to Pulmonary Arterial Hypertension (PAH) patients who are benefitting from treatment with QTI571.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serious Adverse Events |
5; 3; 1; 1; 0; 1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02042014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.