NCT01236339

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2010

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2010

Completed
23 days until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 3, 2014

Completed
Last Updated

June 3, 2014

Status Verified

May 1, 2014

Enrollment Period

2.2 years

First QC Date

November 4, 2010

Results QC Date

January 31, 2014

Last Update Submit

May 1, 2014

Conditions

Liver CirrhosisPortal HypertensionAscites

Outcome Measures

Primary Outcomes (1)

  • 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. * Note: The outcome entered below is the number of participants who were either alive or had a liver transplant at time of study termination.

    Through 24 months

Secondary Outcomes (6)

  • Overall Survival

    Through 24 months

  • Time to Transplant

    Through 24 months

  • Frequency of Paracentesis

    Through 24 months

  • Frequency of Hepatic Encephalopathy

    Through 24 months

  • Procedural Success

    Time of TIPS Procedure (within 2 weeks of enrollment for TIPS arm, at least 6 months after enrollment for Control arm crossover participants)

  • +1 more secondary outcomes

Study Arms (2)

TIPS

EXPERIMENTAL

TIPS with GORE® VIATORR® TIPS Endoprosthesis

Device: TIPS procedure with the 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).

Procedure: LVPDevice: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocol

Interventions

TIPS procedure with the GORE® VIATORR® TIPS EndoprosthesisDEVICE

TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis

TIPS
LVPPROCEDURE

Large Volume Paracentesis

LVP
TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocolDEVICE
LVP

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 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.

You may not qualify if:

  • \> 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Arizona

Tucson, Arizona, United States

Location

University of Maryland-Baltimore

Baltimore, Maryland, United States

Location

MeSH Terms

Conditions

Liver CirrhosisHypertension, PortalAscites

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

Title
Arthur Scott / Clinical Study Manager
Organization
W.L. Gore and Associates, Inc.
artscott@wlgore.com
623.234.5263

Study Officials

  • Thomas Boyer, MD

    University of Arizona College of Medicine

    PRINCIPAL INVESTIGATOR

  • Ziv Haskal, MD

    University of Maryland

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2010

First Posted

November 8, 2010

Study Start

December 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

June 3, 2014

Results First Posted

June 3, 2014

Record last verified: 2014-05

Locations

US(2)