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Low-dose continuous infusion of terlipressin will be administered to six cirrhotic patients with refractory ascites.
Terlipressin continuous infusion will be adminstered via an ambulatory pump initially for 7 days in a clinical pharmacology unit. Serial blood draws for pharmacokinetic analysis will be performed to determine steady state concentration of both terlipressin and 8-lysine-vasopressin during infusion. After establishing safety and tolerance of infusion for 7 days, patients will be transitioned to an outpatient setting where they will be treated with terlipressin continuous infusion for an additional 21 days, monitored daily by home care nurses.
A total of 6 patients will be treated. Monitoring will include successful management of ascites, with reduction in paracentesis procedures and decreased ascites fluid volume, further supported by improvement in renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Terlipressin acetate continuous infusion | Experimental | Continuous infusion of terlipressin starting at 2 mg/day over 7 days in-house and if tolerated continue treatment in the ambulatory setting for 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terlipressin acetate continuous infusion | Drug | Low-dose continuous infusion of Terlipressin administered via ambulatory pump over 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites | Rate of treatment emergent adverse events assessed by physical examination and laboratory safety | 28 day treatment period and 28 day post-treatment |
| Steady State Plasma Levels of Terlipressin and 8-lysine Vasopressin During Terlipressin Continuous Infusion at 2 mg/Day in Cirrhotic Patients With Refractory Ascites | Serial sampling for determination of Terlipressin concentration and metabolite 8-lysine vasopressin in plasma at steady state (Css) | 7 day treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Requirement of Large Volume Paracentesis With Continuous Infusion of Terlipressin | Comparison of pre-treatment and post-treatment incidence of therapeutic paracentesis and change in volume of ascites removed | 28 day post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Yeramian, MD | BioVie Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunter Holmes McGuire VA Medical Center | Richmond | Virginia | 23239 | United States |
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Single site
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| ID | Title | Description |
|---|---|---|
| FG000 | Terlipressin Acetate Continuous Infusion | Continuous infusion of terlipressin starting at 2 mg/day over 7 days in-house and if tolerated continue treatment in the ambulatory setting for 21 days Terlipressin acetate continuous infusion: Low-dose continuous infusion of Terlipressin administered via ambulatory pump over 28 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Terlipressin Acetate Continuous Infusion | Continuous infusion of terlipressin starting at 2 mg/day over 7 days in-house and if tolerated continue treatment in the ambulatory setting for 21 days Terlipressin acetate continuous infusion: Low-dose continuous infusion of Terlipressin administered via ambulatory pump over 28 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites | Rate of treatment emergent adverse events assessed by physical examination and laboratory safety | Enrolled | Posted | Count of Participants | Participants | 28 day treatment period and 28 day post-treatment |
|
|
56 days
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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 | Terlipressin Acetate Continuous Infusion | Continuous infusion of terlipressin starting at 2 mg/day over 7 days in-house and if tolerated continue treatment in the ambulatory setting for 21 days Terlipressin acetate continuous infusion: Low-dose continuous infusion of Terlipressin administered via ambulatory pump over 28 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatic encephalopathy | Hepatobiliary disorders | MedDRA | Systematic Assessment | Hepatic encephalopathy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| tachycardia | Cardiac disorders | MedDRA | Systematic Assessment | tachycardia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Penelope Markham | BioVie | 17035989972 | pmarkham@biovieinc.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 17, 2018 | Mar 15, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077585 | Terlipressin |
| ID | Term |
|---|---|
| D008236 | Lypressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
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Open label prospective study in a cohort of 6 patients
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Open label
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| MELD score | The Model for End-Stage Liver Disease (MELD) is a scoring system for assessing the severity of chronic liver disease and uses the subject's values for total bilirubin, serum creatinine, and the international normalized ratio (INR) for prothrombin time to predict survival. MELD is calculated according to the following formula: MELD = 3.78×ln[serum bilirubin (mg/dL)] + 11.2×ln[INR] + 9.57×ln[serum creatinine (mg/dL)] + 6.43 The possible scores range from 6 to 40. The higher the MELD score the more severe the disease state. | Mean | Full Range | score on a scale |
|
| Serum creatinine | Mean | Full Range | mg/dL |
|
| Child-Pugh score | The Pugh-Child score is determined by scoring five clinical measures of liver disease. A score of 1, 2, or 3 is given to each measure, with 3 being the most severe. The five clinical measures are: total bilirubin, serum albumin, INR, ascites and hepatic encephalopathy. The total score determines severity of disease with Class A being least severe (5-6), Class B more severe (7-9) and Class C most severe (10-15). | Mean | Full Range | score on a scale |
|
|
| Primary | Steady State Plasma Levels of Terlipressin and 8-lysine Vasopressin During Terlipressin Continuous Infusion at 2 mg/Day in Cirrhotic Patients With Refractory Ascites | Serial sampling for determination of Terlipressin concentration and metabolite 8-lysine vasopressin in plasma at steady state (Css) | Posted | Mean | Full Range | ng/mL | 7 day treatment |
|
|
|
| Secondary | Change in Requirement of Large Volume Paracentesis With Continuous Infusion of Terlipressin | Comparison of pre-treatment and post-treatment incidence of therapeutic paracentesis and change in volume of ascites removed | Posted | Mean | Full Range | percent change | 28 day post-treatment |
|
|
|
| 0 |
| 6 |
| 4 |
| 6 |
| 3 |
| 6 |
|
| Bacteremia | Infections and infestations | MedDRA | Systematic Assessment | Bacteremia |
|
| Ruptured umbilical hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment | Umbilical hernia |
|
| Partial bowel obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment | Intestinal obstruction |
|
| diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment | diarrhea |
|
| Energy increased | General disorders | MedDRA | Systematic Assessment | Increased energy |
|
| decreased appetitie | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | Decrease in appetite |
|
| Hyponatremia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | Hyponatremia |
|
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| D036361 |
| Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |