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

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ClinicalTrials.gov Identifier: NCT00995566
Recruitment Status : Terminated (The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury.")
First Posted : October 15, 2009
Results First Posted : February 1, 2012
Last Update Posted : February 7, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date September 17, 2009
First Posted Date October 15, 2009
Results First Submitted Date December 27, 2011
Results First Posted Date February 1, 2012
Last Update Posted Date February 7, 2012
Study Start Date April 2010
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 6, 2012)
  • Percentage of Participants With Elevated Liver Function Post-baseline [ Time Frame: Monthly up to 1 year ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    The criteria used to determine whether participants had both pulmonary edema and veno-occlusive disease was at the discretion of the Investigator.
Original Primary Outcome Measures
 (submitted: October 14, 2009)
liver function tests, haemoglobin, bilirubin, clinical status, duration of exposure, concomitant medications, adverse events and serious adverse events, pulmonary oedema and veno-occlusive disease [ Time Frame: monthly ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Pulmonary Arterial Hypertension
Intervention 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.
Study Groups/Cohorts Thelin Registry Patients
Intervention: Drug: Sitaxentan sodium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: April 26, 2011)
54
Original Estimated Enrollment
 (submitted: October 14, 2009)
5000
Actual Study Completion Date February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium,   France,   Germany
Removed Location Countries Sweden
 
Administrative Information
NCT Number NCT00995566
Other Study ID Numbers B1321045
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2011