Liver CirrhosisNCT01236339

Early TIPS for Ascites Study

A study testing TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis, LVP and TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocol in people with Liver Cirrhosis and Portal Hypertension, run by W.L.Gore & Associates at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 69 years
Conditions the study is for: Liver Cirrhosis, Portal Hypertension, Ascites
What is being tested?: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis, LVP and TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocol
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 2 sitesUnited States
Study dates: Dec 2010to Mar 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 69 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

> 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.

Who cannot join

> 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Maryland-Baltimore
Baltimore, Maryland
University of Arizona
Tucson, Arizona

Other trials in United States

About this study

Official title: The GORE® VIATORR® TIPS Endoprosthesis Versus Large-Volume Paracentesis for the Treatment of Ascites in Patients With Portal Hypertension

Conditions: Liver Cirrhosis, Portal Hypertension, Ascites
Being tested: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis, LVP, TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocol
Medical subject headings: Liver Cirrhosis, Hypertension, Portal, Ascites

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TIPS procedure with the GORE® VIATORR® TIPS EndoprosthesisDevice
TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis
LVPProcedure or surgery
Large Volume Paracentesis
TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocolDevice

Study groups in NCT01236339
Study group	Role	What they receive
TIPS	Experimental	TIPS with GORE® VIATORR® TIPS Endoprosthesis Receives: 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). Receives: Procedure: LVP; Device: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Through 24 months

Secondary outcomes (6)

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.
Measured: Through 24 months
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.
Measured: Through 24 months
Frequency of Paracentesis
Number of paracentesis post randomization
Measured: Through 24 months
Frequency of Hepatic Encephalopathy
Number of episodes of West Haven grade 2 or greater
Measured: 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
Measured: 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.
Measured: Through 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010Mar 2013

First posted8 Nov 2010 (estimated)
Study startDec 2010
Primary completionMar 2013
Study completionMar 2013

Why it stopped: Slow enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Liver CirrhosisStudies of the same condition, open and under way.
More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01236339
Sponsor's protocol ID: VTR 10-03
Status last verified: May 2014
First submitted: 4 Nov 2010
Last updated: 3 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The GORE® VIATORR® TIPS Endoprosthesis Versus Large-Volume Paracentesis for the Treatment of Ascites in Patients With Portal Hypertension
ClinicalTrials.gov ID: NCT01236339
Acronym / sponsor ID: VTR 10-03
Conditions: Liver Cirrhosis, Portal Hypertension, Ascites
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow enrollment
Enrolment: 26 participants (actual)
Lead sponsor: W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 8 Nov 2010 (estimated)
Results: Posted 3 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
TIPS	Experimental	Device: TIPS procedure with the GORE® VIATORR® TIPS EndoprosthesisTIPS with GORE® VIATORR® TIPS Endoprosthesis
LVP	Active comparator	Procedure: LVP, Device: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocolLarge 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).

Who may qualify

Ages: 18 to 69 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

> 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.

Key exclusion criteria (3 listed)

> 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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TIPS procedure with the GORE® VIATORR® TIPS EndoprosthesisTIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis	Device	TIPS
LVPLarge Volume Paracentesis	Procedure or surgery	LVP
TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocol	Device	LVP

Primary outcome

Transplant-free Survival
Time frame: Through 24 months
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.

6 secondary outcomes

Overall Survival
Time frame: Through 24 months
Time to Transplant
Time frame: Through 24 months
Frequency of Paracentesis
Time frame: Through 24 months
Frequency of Hepatic Encephalopathy
Time frame: Through 24 months
Procedural Success
Time frame: 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)
Time frame: Through 24 months

Results and safety

Results posted to the registry on 3 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TIPS	13	2
LVP (Large Volume Paracentesis)	13	0

Primary outcome: Transplant-free Survival

Time frame: Through 24 months. Number. Unit: participants

Measure	TIPS n = 13	LVP (Large Volume Paracentesis) n = 13
Value	11	13

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TIPS	6 of 13 (46.2%)	3 of 13 (23.1%)	Not reported
LVP (Large Volume Paracentesis)	2 of 13 (15.4%)	3 of 13 (23.1%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas Boyer, MD principal investigator

University of Arizona College of Medicine

Ziv Haskal, MD principal investigator

University of Maryland

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transplant-free Survival (time frame: Through 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01236339.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2014.