A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed Thelin (PROSE)

This study has been terminated.
(The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury.")
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00995566
First received: September 17, 2009
Last updated: February 6, 2012
Last verified: May 2011
  Purpose

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).


Condition Intervention
Pulmonary Arterial Hypertension
Drug: Sitaxentan sodium

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Elevated Liver Function Post-baseline [ Time Frame: Monthly up to 1 year ] [ Designated as safety issue: Yes ]
    Elevated liver function: greater than 3 times the upper limit of normal (>3 x ULN) alanine aminotransferase (ALT) and aspartase aminotransferase (AST) levels. Laboratory data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analyses.

  • Percentage of Participants With a Decrease in Hemoglobin Post-baseline [ Time Frame: Monthly up to 1 year ] [ Designated as safety issue: Yes ]
    Laboratory data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analyses.

  • Percentage of Participants With Increases in Total, Conjugated and Non-conjugated Bilirubin Post-baseline [ Time Frame: Monthly up to 1 year ] [ Designated as safety issue: Yes ]
    Total and conjugated bilirubin levels measured from blood, but indirect bilirubin calculated. Indirect bilirubin=Total bilirubin - Conjugated bilirubin. Laboratory data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analyses.

  • Duration of Exposure to Thelin [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
    Time between the first and last dose of Thelin. For participants who continued Thelin from TOPS (another study), the initial TOPS' Thelin start date was used.

  • Adverse Events (AEs) by Seriousness and Relationship to Treatment [ Time Frame: Baseline up to year 1 ] [ Designated as safety issue: Yes ]
    Counts of participants who had AEs or treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Serious adverse events (SAEs) were reported from the time of informed consent. Relatedness to Thelin was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

  • Clinical Status Since Last Visit [ Time Frame: Monthly up to 1 year ] [ Designated as safety issue: Yes ]
    Clinical status determined by status of pulmonary arterial hypertension (PAH) since last visit, reported as PAH remained stable, improved or deteriorated.

  • Concomitant Medications [ Time Frame: Baseline, monthly up to 1 year ] [ Designated as safety issue: Yes ]
    Number of participants with concomitant medication usage reported by drug categories.

  • Bleeding AEs by Seriousness, Relationship to Treatment, Endothelin-A Receptor Antagonist (ERA) Usage, and International Normalized Ratio (INR) Results [ Time Frame: Baseline up to year 1 ] [ Designated as safety issue: Yes ]
    Counts of participants who had bleeding events or treatment-emergent bleeding events, defined as newly occurring or worsening after first dose. Serious bleeding events reported from time of informed consent. Relatedness to Thelin assessed by investigator (Yes/No). ERA usage: was participant taking Vitamin K antagonist? (Yes/No). INR: participant's prothrombin time (PT) ratio. Participants with multiple occurrences of an AE within a category were counted once within the category.

  • Percentage of Participants Who Experienced Pulmonary Edema With the Presence of Veno-occlusive Disease [ Time Frame: Baseline up to year 1 ] [ Designated as safety issue: Yes ]
    The criteria used to determine whether participants had both pulmonary edema and veno-occlusive disease was at the discretion of the Investigator.


Enrollment: 54
Study Start Date: April 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Thelin Registry Patients Drug: Sitaxentan sodium
Please note that this is a non-interventional study and no drug is actually given as an intervention. Instead, patients prescribed THELIN are being followed under real world circumstances. However at the request of the QA group at CT.gov, we were instructed to add sitaxentan sodium as the intervention type, regardless of the fact that this is a non-interventional study.

Detailed Description:

Non-probability sample

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00995566

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Pfizer Investigational Site
Leuven, Belgium, 3000
France
Pfizer Investigational Site
Nice, France, 06000
Germany
Pfizer Investigational Site
Hannover, Germany, 30625
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00995566     History of Changes
Other Study ID Numbers: B1321045
Study First Received: September 17, 2009
Results First Received: December 27, 2011
Last Updated: February 6, 2012
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014