Current partner codePEPTIDESDE
NCT03107091·Phase 2·INTERVENTIONAL

Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites

Status

Completed

Phase

Phase 2

Enrollment

6

Locations

1

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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

Full 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.

Interventions

Treatment arms and agents.

DRUG

Terlipressin acetate continuous infusion

Low-dose continuous infusion of Terlipressin administered via ambulatory pump over 28 days

Timeline

From registration to results.

  1. First posted

    Apr 11, 2017

  2. Study start

    Jul 15, 2017

  3. Primary completion

    Apr 1, 2019

  4. Study completion

    Apr 25, 2019

  5. Results posted

    Jul 13, 2021

  6. Registry updated

    Jul 13, 2021

Outcomes

What the study measures.

Primary outcomes

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)

Secondary outcomes

Change in Requirement of Large Volume Paracentesis With Continuous Infusion of Terlipressin

Time frame · 28 day post-treatment

Comparison of pre-treatment and post-treatment incidence of therapeutic paracentesis and change in volume of ascites removed

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Patients with cirrhosis and refractory ascites who required 3 or more large volume (4 liters and more) paracenteses in the previous 60 days Exclusion Criteria: * 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 * 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.

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Terlipressin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.