Clinical trial NCT00995566: A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed Thelin
Official title: Thelin (Sitaxentan Sodium) Patient Safety Registry A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed Thelin
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-10-15
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * All patients enrolled must meet the usual prescribing criteria for Thelin as per the Summary of Product Characteristics (SmPC) and are enrolled in the registry at the clinician's discretion.
* All prescribers are offered the opportunity to participate in the registry, assuming they have received appropriate educational materials

Brief summary: The Thelin Patient Safety Registry is a post-marketing program in the European Union (EU) that is designed to supplement the reporting of spontaneous adverse events (AE) and better characterize known and potential safety signals for Thelin. The registry is a secure, restricted access, electronic system which collects anonymous, pre-defined, patient-level data on demographic variables, safety monitoring measurements (i.e. liver function tests, haemoglobin and international normalized ratio (INR) measurements), concomitant medications, information on AEs and Thelin drug discontinuation. Regular review of the data is conducted to assess the frequency of identified safety risks and to monitor for the emergence of new safety signals at monthly pharmacovigilance meetings, quarterly signal detection meetings, and for each Periodic Safety Update Report (PSUR).

Detailed description: Non-probability sample

Eligibility criteria: Inclusion Criteria:

* Evidence of a personally signed and dated informed consent document by the patient indicating that he/she (or a legally acceptable representative) has been informed of all pertinent aspects of the study is a requirement for inclusion.
* Additional inclusion criteria reflect the approved label for Thelin as outlined in the SmPC.

Exclusion Criteria:

* There are no specific exclusion criteria for enrollment in the Thelin Patient Safety Registry, with the exception of those reflected in the approved label for Thelin as outlined in the SmPC.

Primary outcomes:
measure: Percentage of Participants With Elevated Liver Function Post-baseline
timeFrame: Monthly up to 1 year
measure: Percentage of Participants With a Decrease in Hemoglobin Post-baseline
timeFrame: Monthly up to 1 year
measure: Percentage of Participants With Increases in Total, Conjugated and Non-conjugated Bilirubin Post-baseline
timeFrame: Monthly up to 1 year
measure: Duration of Exposure to Thelin
timeFrame: 1 Year
measure: Adverse Events (AEs) by Seriousness and Relationship to Treatment
timeFrame: Baseline up to year 1
measure: Clinical Status Since Last Visit
timeFrame: Monthly up to 1 year
measure: Concomitant Medications
timeFrame: Baseline, monthly up to 1 year
measure: Bleeding AEs by Seriousness, Relationship to Treatment, Endothelin-A Receptor Antagonist (ERA) Usage, and International Normalized Ratio (INR) Results
timeFrame: Baseline up to year 1
measure: Percentage of Participants Who Experienced Pulmonary Edema With the Presence of Veno-occlusive Disease
timeFrame: Baseline up to year 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Nice
country: France
facility: Pfizer Investigational Site
city: Hannover
country: Germany
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: