Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Otsuka America Pharmaceutical | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Open Label Study evaluating the safety and efficacy of tolvaptan in the treatment of ascites in liver cirrhosis. Tolvaptan will be administered in combination with current ascites management.
This is an open label, 12 week dose escalating pilot study of tolvaptan (initiating at 15 mg a day and increasing to 30 mg a day as tolerated in addition to standard ascites treatment) of 10 cirrhotic subjects meeting all inclusion/exclusion criteria. Subjects are monitored for changes in frequency of paracentesis, quantity of ascites removed, and body weight. Additionally, subjects laboratory values were checked frequently during the first days of dosing to ensure tolerability and slow correction/increase in serum sodium.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tolvaptan | Experimental | Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolvaptan | Drug | Oral administration once daily Dosage will range from 15 mg to 30 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Worsening Ascites (Increase in Number of Paracentesis Procedures to Remove 2 Liters of Ascites Fluid) | Increase in number of therapeutic paracentesis (removal of > 2 litres of ascites fluid) during 12 weeks of study drug dosing versus 12 weeks before study drug dosing | Week 12 |
| Number of Subjects With Worsening Ascites (Defined as Greater Than 2 kg Weight Gain) | This outcome will provide the number of subjects with a weight increase of > 2kg from baseline (worsening ascites) | 12 weeks of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Reduction of Ascites (Weight Loss of 2 kg or More) | Number of patients with reduction of ascites is defined as reduction of weight by at least 2 kg during study drug dosing | 12 weeks |
| Number of Patients With Abnormally Low Levels of Sodium (Sodium Levels Between 130 mmol/L and 135 mmol/L) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Giuseppe (Joseph) Morelli, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Hepatology | Gainesville | Florida | 32610-0277 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tolvaptan | Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tolvaptan | Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With Worsening Ascites (Increase in Number of Paracentesis Procedures to Remove 2 Liters of Ascites Fluid) | Increase in number of therapeutic paracentesis (removal of > 2 litres of ascites fluid) during 12 weeks of study drug dosing versus 12 weeks before study drug dosing | Posted | Number | participants | Week 12 |
|
|
Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tolvaptan | Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Giuseppe (Joseph) Morelli, MD | University of Florida | 352-273-9508 | giuseppe.morelli@medicine.ufl.edu |
Not provided
| ID | Term |
|---|---|
| D001201 | Ascites |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077602 | Tolvaptan |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Number of Patients with new episodes of hyponatremia (abnormally low levels of sodium) defined as sodium >130 mmol/L and <135 mmol/L |
| 12 weeks |
| Time From Baseline to Worsening Ascites (Requiring 1 or More Therapeutic Paracentesis to Remove Ascites Fluid) | This outcome will describe the average time from baseline for subjects to require a therapeutic paracentesis to remove ascites fluid. | 12 weeks of study drug |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Patients With Reduction of Ascites (Weight Loss of 2 kg or More) | Number of patients with reduction of ascites is defined as reduction of weight by at least 2 kg during study drug dosing | Posted | Number | participants | 12 weeks |
|
|
|
| Secondary | Number of Patients With Abnormally Low Levels of Sodium (Sodium Levels Between 130 mmol/L and 135 mmol/L) | Number of Patients with new episodes of hyponatremia (abnormally low levels of sodium) defined as sodium >130 mmol/L and <135 mmol/L | Posted | Number | participants | 12 weeks |
|
|
|
| Primary | Number of Subjects With Worsening Ascites (Defined as Greater Than 2 kg Weight Gain) | This outcome will provide the number of subjects with a weight increase of > 2kg from baseline (worsening ascites) | Posted | Number | participants | 12 weeks of study drug |
|
|
|
| Secondary | Time From Baseline to Worsening Ascites (Requiring 1 or More Therapeutic Paracentesis to Remove Ascites Fluid) | This outcome will describe the average time from baseline for subjects to require a therapeutic paracentesis to remove ascites fluid. | Posted | Median | Full Range | Days | 12 weeks of study drug |
|
|
|
| 1 |
| 10 |
| 9 |
| 10 |
| Asterixis | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Cold Sensitivity | General disorders | CTCAE 4.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE 4.0 | Systematic Assessment |
|
| Dry mouth | General disorders | CTCAE 4.0 | Systematic Assessment |
|
| Elevated serum creatinine | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
|
| Fever | General disorders | CTCAE 4.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
|
| Hyopmagnesemia | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
|
| Hyperkalemia | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
|
| Hypernatrimia | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
|
| Hypertension | Cardiac disorders | CTCAE 4.0 | Systematic Assessment |
|
| Lethargy | General disorders | CTCAE 4.0 | Systematic Assessment |
|
| Lung pain | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Mouth soreness | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Nighttime blackouts | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
|
| Pleuritic chest pain | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Polydipsia | General disorders | CTCAE 4.0 | Systematic Assessment |
|
| Polyphagia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | CTCAE 4.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
|
| Stomach cramps | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Stress | Psychiatric disorders | CTCAE 4.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
|
| Vertigo | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
|
Not provided
Not provided