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.
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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- BioVie Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Yeramian, MD, Study director, BioVie Inc.
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
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
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.
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
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?
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.