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The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury."
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thelin Registry Patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitaxentan sodium | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Brussels | 1070 | Belgium | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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The Sitaxentan Sodium program was discontinued December 10, 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Thelin Registry Patients | The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Thelin Registry Patients | The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full Analysis Set (FAS): participants enrolled in Patient Registry of Sitaxentan in Europe (PROSE). Number of participants analyzed (N): participants with evaluable data. | Posted | Number | percentage of participants | Monthly up to 1 year |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Thelin Registry Patients | The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial tachycardia | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
The protocol did not identify the priority of endpoints. Therefore, all endpoints arbitrarily assigned as primary.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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|
| 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. | Monthly up to 1 year |
| Concomitant Medications | Number of participants with concomitant medication usage reported by drug categories. | 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. | 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. | Baseline up to year 1 |
| Leuven |
| 3000 |
| Belgium |
| Pfizer Investigational Site | Nice | 06000 | France |
| Pfizer Investigational Site | Hanover | 30625 | Germany |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | Data not summarized due to the small number of participants in database. | Posted | Number | percentage of participants | Monthly up to 1 year |
|
|
| Primary | 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. | Data not summarized due to the small number of participants in database. | Posted | Number | percentage of participants | Monthly up to 1 year |
|
|
| Primary | 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. | FAS | Posted | Mean | Standard Deviation | months | 1 Year |
|
|
|
| Primary | 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. | FAS | Posted | Number | participants | Baseline up to year 1 |
|
|
|
| Primary | 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. | Data not summarized due to the small number of participants in database. | Posted | Number | participants | Monthly up to 1 year |
|
|
| Primary | Concomitant Medications | Number of participants with concomitant medication usage reported by drug categories. | Data not summarized due to the small number of participants in database. | Posted | Number | participants | Baseline, monthly up to 1 year |
|
|
| Primary | 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. | FAS | Posted | Number | participants | Baseline up to year 1 |
|
|
|
| Primary | 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. | FAS | Posted | Number | percentage of participants | Baseline up to year 1 |
|
|
|
| 6 |
| 54 |
| 6 |
| 54 |
| Hyperparathyroidism primary | Endocrine disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Hepatitis toxic | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Injection site infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Anal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Measurements |
|---|---|
|
| SAE related to Thelin |
|
| Title | Measurements |
|---|---|
|
| Serious bleeding event related to Thelin |
|
| Bleeding event with ERA usage |
|
| Bleeding event with INR results |
|