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Slow enrollment
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The purpose of this study is to demonstrate that TIPS with the GORE® VIATORR® TIPS Endoprosthesis improves transplant-free survival compared to LVP alone in patients who have cirrhosis of the liver with portal hypertension and difficult to treat ascites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIPS | Experimental | TIPS with GORE® VIATORR® TIPS Endoprosthesis |
|
| LVP | Active Comparator | Large Volume Paracentesis *A subject may be crossed-over from large volume paracentesis to TIPS with GORE® VIATORR® TIPS Endoprosthesis if the subject has completed their six month study visit and has met the criteria for cross-over (LVP failure). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis | Device | TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Transplant-free Survival | Time from randomization to death from any cause prior to transplant. Subjects who undergo liver transplant will be censored at the time of transplant. Subjects without an event will be censored at the date of last follow-up.
| Through 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Time from randomization to death from any cause. Subjects without an event will be censored at the date of last follow-up. > *Note: Outcome measure entered below is number of subjects alive at time of study termination. | Through 24 months |
| Time to Transplant |
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Inclusion Criteria:
> Patient has cirrhosis of the liver with portal hypertension
> Patient has difficult to treat ascites
> Patient is 18 years or older and <70 years old at randomization
> Patient is willing and able to comply with all study protocol requirements, including specified follow-up and testing.
> Patient, or legal authorized representative, is willing to provide written informed consent prior to enrollment in the study.
Exclusion Criteria:
> Patient has more than 6 large volume paracenteses within 90 days prior to randomization
> Patient is contraindicated for TIPS placement
> Patient has had previous TIPS placement
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Boyer, MD | University of Arizona College of Medicine | Principal Investigator |
| Ziv Haskal, MD | University of Maryland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | United States | |||
| University of Maryland-Baltimore |
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| ID | Title | Description |
|---|---|---|
| FG000 | TIPS | TIPS with GORE® VIATORR® TIPS Endoprosthesis |
| FG001 | LVP (Large Volume Paracentesis) | Large Volume Paracentesis *A subject may be crossed-over from large volume paracentesis to TIPS with GORE® VIATORR® TIPS Endoprosthesis if the subject has completed their six month study visit and has met the criteria for cross-over (LVP failure) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients who have cirrhosis of the liver with portal hypertension and difficult to treat ascites
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| ID | Title | Description |
|---|---|---|
| BG000 | TIPS | TIPS with GORE® VIATORR® TIPS Endoprosthesis > > TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis |
| BG001 | LVP (Large Volume Paracentesis) |
| 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 | Transplant-free Survival | Time from randomization to death from any cause prior to transplant. Subjects who undergo liver transplant will be censored at the time of transplant. Subjects without an event will be censored at the date of last follow-up.
| Posted | Number | participants | Through 24 months |
|
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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 | TIPS | TIPS with GORE® VIATORR® TIPS Endoprosthesis > > TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erosive esophagitis | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatorenal syndrome | Hepatobiliary disorders | MedDRA Version 13.1 | Systematic Assessment |
Early termination due to very low enrollment.No subjects completed 24 month follow-up,sample size too small for adequate statistical analysis.Collected Adverse Events limited to hospitalizations and Liver Disease Complications as defined in protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arthur Scott / Clinical Study Manager | W.L. Gore and Associates, Inc. | 623.234.5263 | artscott@wlgore.com |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D006975 | Hypertension, Portal |
| D001201 | Ascites |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| LVP | Procedure | Large Volume Paracentesis |
|
| TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocol | Device |
|
Time from randomization to transplant. Subjects without an event will be censored at the date of last follow-up or date of death without transplant. *Note: Outcome measure entered is number of subjects who received a liver transplant at time of study termination. |
| Through 24 months |
| Frequency of Paracentesis | Number of paracentesis post randomization | Through 24 months |
| Frequency of Hepatic Encephalopathy | Number of episodes of West Haven grade 2 or greater | Through 24 months |
| Procedural Success | Successful creation of a VIATORR(R) device lined portosystemic shunt spanning a hepatic vein and intrahepatic branch of the portal vein *Note: Control (LVP) arm includes only subjects who crossed over to TIPS | Time of TIPS Procedure (within 2 weeks of enrollment for TIPS arm, at least 6 months after enrollment for Control arm crossover participants) |
| Liver Disease Complications (Adverse Events) | Overall frequency and component frequencies. Complications will include hepatic encephalopathy, hepatic hydrothorax, hepatoma, hepatorenal syndrome (Type 1 or Type 2), hyponatremia (<130mEq / L), spontaneous bacterial peritonitis, and variceal bleeding. | Through 24 months |
| Baltimore |
| Maryland |
| United States |
Large Volume Paracentesis
*A subject may be crossed-over from large volume paracentesis to TIPS with GORE® VIATORR® TIPS Endoprosthesis if the subject has completed their six month study visit and has met the criteria for cross-over (LVP failure).
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Overall Survival | Time from randomization to death from any cause. Subjects without an event will be censored at the date of last follow-up. > *Note: Outcome measure entered below is number of subjects alive at time of study termination. | Posted | Number | participants | Through 24 months |
|
|
|
| Secondary | Time to Transplant | Time from randomization to transplant. Subjects without an event will be censored at the date of last follow-up or date of death without transplant. *Note: Outcome measure entered is number of subjects who received a liver transplant at time of study termination. | Posted | Number | participants | Through 24 months |
|
|
|
| Secondary | Frequency of Paracentesis | Number of paracentesis post randomization | Posted | Number | Number of episodes | Through 24 months |
|
|
|
| Secondary | Frequency of Hepatic Encephalopathy | Number of episodes of West Haven grade 2 or greater | Posted | Number | Number of episodes | Through 24 months |
|
|
|
| Secondary | Procedural Success | Successful creation of a VIATORR(R) device lined portosystemic shunt spanning a hepatic vein and intrahepatic branch of the portal vein *Note: Control (LVP) arm includes only subjects who crossed over to TIPS | Posted | Number | participants | Time of TIPS Procedure (within 2 weeks of enrollment for TIPS arm, at least 6 months after enrollment for Control arm crossover participants) |
|
|
|
| Secondary | Liver Disease Complications (Adverse Events) | Overall frequency and component frequencies. Complications will include hepatic encephalopathy, hepatic hydrothorax, hepatoma, hepatorenal syndrome (Type 1 or Type 2), hyponatremia (<130mEq / L), spontaneous bacterial peritonitis, and variceal bleeding. | Posted | Number | participants | Through 24 months |
|
|
|
| 6 |
| 13 |
| 3 |
| 13 |
| EG001 | LVP (Large Volume Paracentesis) | Large Volume Paracentesis *A subject may be crossed-over from large volume paracentesis to TIPS with GORE® VIATORR® TIPS Endoprosthesis if the subject has completed their six month study visit and has met the criteria for cross-over (LVP failure). | 2 | 13 | 3 | 13 |
| Incarcerated umbilical hernia | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Liver failure | Hepatobiliary disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Fungal sepsis | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
|
| Hyperglycemic hyperosmolar nonketotic syndrome | Metabolism and nutrition disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Hepatoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | Systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Umbilical hernia repair | Surgical and medical procedures | MedDRA Version 13.1 | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Hepatic hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Systematic Assessment |
|
Gore has the right to review disclosures, requesting a delay of less than 90 days. Each investigator will postpone single center publications until after disclosure of multi-center data, less than 12 months from study completion/termination at all participating sites.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Subjects with Hepatic Hydrothorax |
|
| Subjects with Hepatoma |
|
| Subjects with Hepatorenal Syndrome Type 1 |
|
| Subjects with Hepatorenal Syndrome Type II |
|
| Subjects with Hyponatremia |
|
| Subjects with Spontaneous Bacterial Peritonitis |
|
| Subjects with Hepatic Encephalopathy |
|