An observational study in Pulmonary Arterial Hypertension, sponsored by Pfizer. Terminated at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-07.
Sponsored by Pfizer · Observational
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).
Non-probability sample
761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.
This study's enrollment of 54 is below the median of 100 across 197 observational studies indexed under Pulmonary Arterial Hypertension.
Browse Pulmonary Arterial Hypertension studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Percentage of Participants With Elevated Liver Function Post-baseline
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.
Time frame: Monthly up to 1 year
Percentage of Participants With a Decrease in Hemoglobin Post-baseline
Laboratory data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analyses.
Time frame: Monthly up to 1 year
Percentage of Participants With Increases in Total, Conjugated and Non-conjugated Bilirubin Post-baseline
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.
Time frame: Monthly up to 1 year
Duration of Exposure to Thelin
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.
Time frame: 1 Year
Adverse Events (AEs) by Seriousness and Relationship to Treatment
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.
Time frame: Baseline up to year 1
Clinical Status Since Last Visit
Clinical status determined by status of pulmonary arterial hypertension (PAH) since last visit, reported as PAH remained stable, improved or deteriorated.
Time frame: Monthly up to 1 year
Concomitant Medications
Number of participants with concomitant medication usage reported by drug categories.
Time frame: Baseline, monthly up to 1 year
Bleeding AEs by Seriousness, Relationship to Treatment, Endothelin-A Receptor Antagonist (ERA) Usage, and International Normalized Ratio (INR) Results
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.
Time frame: Baseline up to year 1
Percentage of Participants Who Experienced Pulmonary Edema With the Presence of Veno-occlusive Disease
The criteria used to determine whether participants had both pulmonary edema and veno-occlusive disease was at the discretion of the Investigator.
Time frame: Baseline up to year 1
The Sitaxentan Sodium program was discontinued December 10, 2010.
| Milestone | Thelin Registry Patients |
|---|---|
| Started | 54 |
| Completed | 0 |
| Not completed | 54 |
| Withdrew: Adverse event | 2 |
| Withdrew: Early study termination | 52 |
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 | Thelin Registry Patients |
|---|---|
| ALT >3 xULN | 2.2 |
| AST >3 xULN | 2.2 |
Laboratory data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analyses.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
| months | Thelin Registry Patients |
|---|---|
| Duration of Exposure to Thelin | 21.5 ± 15.3 |
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.
| participants | Thelin Registry Patients |
|---|---|
| Any TEAE | 11 |
| TEAE related to Thelin | 1 |
| SAE | 6 |
| SAE related to Thelin | 1 |
Clinical status determined by status of pulmonary arterial hypertension (PAH) since last visit, reported as PAH remained stable, improved or deteriorated.
No measurements were reported for this outcome.
Number of participants with concomitant medication usage reported by drug categories.
No measurements were reported for this outcome.
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.
| participants | Thelin Registry Patients |
|---|---|
| Any bleeding event | 1 |
| Bleeding event related to Thelin | 0 |
| Serious bleeding event | 0 |
| Serious bleeding event related to Thelin | 0 |
| Bleeding event with ERA usage | 0 |
| Bleeding event with INR results | 0 |
The criteria used to determine whether participants had both pulmonary edema and veno-occlusive disease was at the discretion of the Investigator.
| percentage of participants | Thelin Registry Patients |
|---|---|
| Percentage of Participants Who Experienced Pulmonary Edema With the Presence of Veno-occlusive Disease | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Thelin Registry Patients | — | 6/54 (11.1%) | 6/54 (11.1%) |
| Event | Thelin Registry Patients |
|---|---|
| Cardiac failureCardiac disorders | 3/54 |
| Hyperparathyroidism primaryEndocrine disorders | 1/54 |
| OedemaGeneral disorders | 1/54 |
| Hepatitis toxicHepatobiliary disorders | 1/54 |
| Injection site infectionInfections and infestations | 1/54 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 1/54 |
| ParaesthesiaNervous system disorders | 1/54 |
| AgitationPsychiatric disorders | 1/54 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/54 |
| Pulmonary arterial hypertensionRespiratory, thoracic and mediastinal disorders | 1/54 |
| Event | Thelin Registry Patients |
|---|---|
| Atrial tachycardiaCardiac disorders | 1/54 |
| Anal haemorrhageGastrointestinal disorders | 1/54 |
| NauseaGastrointestinal disorders | 1/54 |
| VomitingGastrointestinal disorders | 1/54 |
| Chest painGeneral disorders | 1/54 |
| ArthritisMusculoskeletal and connective tissue disorders | 1/54 |
| HeadacheNervous system disorders | 1/54 |
| HypotensionVascular disorders | 1/54 |
| Age Continuous(years) | Thelin Registry Patients |
|---|---|
| Mean | 60.5 ± 18.1 |
| Sex: Female, Male(Participants) | Thelin Registry Patients |
|---|---|
| Female | 41 |
| Male | 13 |
This study is terminated, as verified in May 2011. You cannot join it, but the record below documents what was studied.
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Pulmonary Arterial Hypertension→
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