CirrhosisPhase 2NCT03107091

Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites

A Phase 2 study testing Terlipressin acetate continuous infusion in people with Cirrhosis and Ascites Hepatic, run by BioVie Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Low-dose continuous infusion of terlipressin will be administered to six cirrhotic patients with refractory ascites. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Cirrhosis, Ascites Hepatic
What is being tested?: Terlipressin acetate continuous infusion
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: 15 Jul 2017to 25 Apr 2019
Phase: Phase 2
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with cirrhosis and refractory ascites who required 3 or more large volume (4 liters and more) paracenteses in the previous 60 days

Who cannot join

Ascites with causes other than cirrhosis such as nephrogenic ascites or malignant ascites due to peritoneal carcinomatosis
Total bilirubin > 5 mg/dL
Blood clotting International normalized ratio (INR) > 2.5
Serum creatinine > 2.0 mg/dL
Current or recent (within 3 months of consent) renal dialysis
Hepatic encephalopathy grade 3 or 4

Show all 20Show fewer

Superimposed acute liver failure/injury due to factors other than alcoholic hepatitis, including acute viral hepatitis, drugs, medications (e.g., acetaminophen), or other toxins (e.g., mushroom [Amanita] poisoning)
Current or recent treatment (within 7 days) with octreotide, midodrine, vasopressin, dopamine or other vasopressors
Respiratory failure requiring positive airway pressure devices or intubation
SIRS/sepsis episode in the previous 28 days from consent
Episode of spontaneous bacterial peritonitis or gastrointestinal hemorrhage within 28 days of consent
Ongoing documented or suspected infection
Severe cardiovascular disease that are contraindication to terlipressin therapy such as advanced arteriosclerosis, arrhythmia, coronary insufficiency or uncontrolled hypertension
Findings suggestive of organic renal disease (severe proteinuria/hematuria, or abnormal renal ultrasound suggestive of obstructive or other renal pathology)
Severe comorbidity that in the opinion of the Investigator would affect short-term prognosis and/or disallow safe participation in the trial (such as for example, severe anemia or pancytopenia, advanced neoplasia, hepatocellular carcinoma [confirmed with serum alpha1-fetoprotein testing], severe chronic obstructive pulmonary disease or asthma)
Alcoholics who have not been abstinent for the past 6 months
Transjugular intrahepatic portosystemic shunt or other surgical shunt
For female patients: Confirmed pregnancy
Known allergy or hypersensitivity to terlipressin
Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of consent.

Trial locations and contacts

1 site in 1 country.

United States1 site

Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23239

Other trials in United States

About this study

Official title: Safety and Efficacy of Low-dose Terlipressin Delivered by Continuous Intravenous Infusion in Patients With Cirrhosis and Ascites Refractory to, or Intolerant of, Diuretic Therapy, Requiring Large Volume Paracentesis

Low-dose continuous infusion of terlipressin will be administered to six cirrhotic patients with refractory ascites.

Read the detailed description

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.

Conditions: Cirrhosis, Ascites Hepatic
Being tested: Terlipressin acetate continuous infusion
Keywords: Terlipressin, Terlipressin acetate
Medical subject headings: Fibrosis

What participants receive

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

Terlipressin acetate continuous infusionDrug
Also called Terlipressin
Low-dose continuous infusion of Terlipressin administered via ambulatory pump over 28 days

Study groups in NCT03107091
Study group	Role	What they receive
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 Receives: Drug: Terlipressin acetate continuous infusion

What is being measured

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

Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites
Rate of treatment emergent adverse events assessed by physical examination and laboratory safety
Measured: 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)
Measured: 7 day treatment

Secondary outcomes (1)

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
Measured: 28 day post-treatment

Timeline

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

15 Jul 201725 Apr 2019

First posted11 Apr 2017
Study start15 Jul 2017
Primary completion1 Apr 2019
Study completion25 Apr 2019

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 CirrhosisStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Open label prospective study in a cohort of 6 patients
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03107091
Sponsor's protocol ID: CIT-001
Status last verified: Apr 2019
First submitted: 20 Nov 2016
Last updated: 13 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Low-dose Terlipressin Delivered by Continuous Intravenous Infusion in Patients With Cirrhosis and Ascites Refractory to, or Intolerant of, Diuretic Therapy, Requiring Large Volume Paracentesis
ClinicalTrials.gov ID: NCT03107091
Acronym / sponsor ID: CIT-001
Conditions: Cirrhosis, Ascites Hepatic
Keywords: Terlipressin, Terlipressin acetate
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: BioVie Inc.Industry (pharma, biotech, devices)
Study start: 15 Jul 2017 (actual)
Primary completion: 1 Apr 2019 (actual)
Study completion: 25 Apr 2019 (actual)
First posted: 11 Apr 2017 (actual)
Results: Posted 13 Jul 2021

Clinical summary

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

Low-dose continuous infusion of terlipressin will be administered to six cirrhotic patients with refractory ascites.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Open label prospective study in a cohort of 6 patients

Arm	Type	Receives
Terlipressin acetate continuous infusion	Experimental	Drug: Terlipressin acetate continuous infusionContinuous 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

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients with cirrhosis and refractory ascites who required 3 or more large volume (4 liters and more) paracenteses in the previous 60 days

Key exclusion criteria (20 listed)

Ascites with causes other than cirrhosis such as nephrogenic ascites or malignant ascites due to peritoneal carcinomatosis
Total bilirubin > 5 mg/dL
Blood clotting International normalized ratio (INR) > 2.5
Serum creatinine > 2.0 mg/dL
Current or recent (within 3 months of consent) renal dialysis

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
Terlipressin acetate continuous infusionAlso: TerlipressinLow-dose continuous infusion of Terlipressin administered via ambulatory pump over 28 days	Drug	Terlipressin acetate continuous infusion

Primary outcome

Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites
Time frame: 28 day treatment period and 28 day post-treatment
Rate of treatment emergent adverse events assessed by physical examination and laboratory safety
Steady State Plasma Levels of Terlipressin and 8-lysine Vasopressin During Terlipressin Continuous Infusion at 2 mg/Day in Cirrhotic Patients With Refractory Ascites
Time frame: 7 day treatment
Serial sampling for determination of Terlipressin concentration and metabolite 8-lysine vasopressin in plasma at steady state (Css)

1 secondary outcome

Change in Requirement of Large Volume Paracentesis With Continuous Infusion of Terlipressin
Time frame: 28 day post-treatment

Results and safety

Results posted to the registry on 13 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Terlipressin Acetate Continuous Infusion	6	5

Primary outcome: Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites

Time frame: 28 day treatment period and 28 day post-treatment. Count of participants. Unit: Participants

Measure	Terlipressin Acetate Continuous Infusion n = 6
TEAE	6
Serious AE	4
Related TEAE	3
Serious related TEAE	0
TEAE leading to drug withdrawal	3
Grade 3 TEAE	4
Fatal TEAE	0

Population analysed: Enrolled

Primary outcome: Steady State Plasma Levels of Terlipressin and 8-lysine Vasopressin During Terlipressin Continuous Infusion at 2 mg/Day in Cirrhotic Patients With Refractory Ascites

Time frame: 7 day treatment. Mean (Full Range). Unit: ng/mL

Measure	Terlipressin Acetate Continuous Infusion n = 6
Terlipressin	2.48 (1.67 to 3.23)
8-lysine vasopressin	0.089 (0.07 to 0.138)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 56 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Terlipressin Acetate Continuous Infusion	4 of 6 (66.7%)	3 of 6 (50%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Patrick Yeramian, MD study director

BioVie Inc.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Terlipressin acetate continuous infusion in people with Cirrhosis and Ascites Hepatic, run by BioVie Inc. at 1 site in United States.

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 1 inclusion and 20 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: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jul 2021). 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?

Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites (time frame: 28 day treatment period and 28 day post-treatment). The study lists 2 primary outcomes in all. 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 NCT03107091.

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 13 Jul 2021.