Cirrhosis Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacodynamics of SYNB1020 in Hepatic Insufficiency and Cirrhosis Patients
Verified date | May 2021 |
Source | Synlogic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This Phase 1b/2a, randomized, double-blind, placebo-controlled study was designed to evaluate the safety, tolerability, and pharmacodynamics of SYNB1020 in hepatic insufficiency and cirrhosis patients with hyperammonemia, with dosing of the investigational medicinal product (IMP) administered in an inpatient unit and subsequent outpatient follow-up for SYNB1020 clearance in two study parts.
Status | Terminated |
Enrollment | 23 |
Est. completion date | July 19, 2019 |
Est. primary completion date | July 19, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 74 Years |
Eligibility | Key Inclusion Criteria: - Age = 18 to < 75 years - Females must have been of non-childbearing potential - Able and willing to complete informed consent process - Available for and agreed to all study procedures - Screening laboratory evaluations within defined acceptable limits or judged to be not clinically significant by the Investigator - Diagnosis of chronic, stable, hepatic insufficiency with features of cirrhosis due to any etiology - Evidence of elevated portal hypertension by either liver stiffness measurement, the presence of abdominal or esophageal varices, splenomegaly or ascites (Part 2 only) - Elevated venous ammonia (Part 2 only) Key Exclusion Criteria: - Body mass index < 18.5 or = 40 kg/m^2 - Administration or ingestion of an investigational drug within 8 weeks or 5 half-lives, whichever was longer, prior to screening or current enrollment in an investigational study - Allergy to ranitidine or intolerance to any of the excipients (glycerol, CS Health Easy Fiber) - Any condition, prescription medication or over-the-counter product that may possibly have affected absorption of medications or nutrients - Dependence on drugs of abuse - Apart from chronic liver disease, any acute or chronic medical, surgical, psychiatric, or social condition including history of cerebrovascular disease (stroke, transient ischemic attack) or dementia, or laboratory abnormality that may have increased the subject risk associated with study participation, compromised adherence to study procedures and requirements, confounded interpretation of the safety, kinetics, or PD results, and, in the judgment of the Investigator, made the subject inappropriate for enrollment - Current or past hepatic encephalopathy of Grade 2 or higher requiring hospitalization - Child-Turcotte-Pugh score > 9 - History of liver transplant |
Country | Name | City | State |
---|---|---|---|
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Southern California Research Center | Coronado | California |
United States | Inland Empire Liver Foundation | Rialto | California |
United States | McGuire VA Medical Center | Richmond | Virginia |
United States | Texas Liver Institute | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Synlogic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Treatment-Emergent Adverse Events | Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, as follows: Grade 1 (mild/asymptomatic; no intervention); Grade 2 (moderate; minimal intervention); Grade 3 (severe/medically significant; hospitalization indicated; disabling); Grade 4 (life-threatening; urgent intervention required). Adverse events (AEs) were reported based on clinical laboratory tests, vital sign and weight measurements, physical examinations, and any other medically indicated assessments, including subject interviews, from the time informed consent was signed through the end of the safety follow-up period. AEs were considered to be treatment emergent adverse events (TEAEs) if they occurred or worsened in severity after the first dose of study treatment. TEAEs were considered treatment-related if relationship to study drug was possibly related, probably related, definitely related, or a missing relationship. | Up to 70 days | |
Secondary | Number of Participants With Clearance of SYNB1020 From Feces | SYNB1020 transit through the gastrointestinal tract was measured with qualitative and quantitative polymerase chain reaction (PCR) fecal assays from fecal samples collected at baseline, daily during the dosing period (Days 1 through 6), at the time of discharge from the inpatient unit (Day 7), and at follow-up visits beginning 7±1 days after the last dose and continuing biweekly until a subject had a negative SYNB1020 fecal test. SYNB1020 clearance reflects a test value of below the limit of quantitation (BLQ) occurring after the indicated number of days following the last dose of study treatment. | Up to 65 days | |
Secondary | Daily Fasting Spot Venous Ammonia | Fasting spot venous ammonia was collected at baseline (Day -2) and at the time of discharge from the inpatient unit (Day 7). | Up to 9 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01884415 -
Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis
|
Phase 3 | |
Recruiting |
NCT05014594 -
Sodium-glucose Linked Transporter 2 (SGLT-2) Inhibitors in Recurrent Ascites: a Pilot RCT
|
Phase 2 | |
Not yet recruiting |
NCT03631147 -
The Effect of Rifaximin on Portal Vein Thrombosis
|
N/A | |
Completed |
NCT04939350 -
Evaluation of the Vaccination Coverage of Cirrhotic Patients Followed in the General Hospitals in France in 2021
|
||
Completed |
NCT02528760 -
To Determine the Role of Prokinetics in Feed Intolerance in Critically Ill Cirrhosis
|
N/A | |
Recruiting |
NCT05484206 -
Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434
|
Phase 1 | |
Not yet recruiting |
NCT05538546 -
Baveno VI Criteria in Dynamic Monitoring of High-risk Varices in Compensated Cirrhotic Patients
|
||
Not yet recruiting |
NCT04053231 -
Hepatocarcinoma Recurrence on the Liver Study - Part2
|
||
Recruiting |
NCT02983968 -
Use of the French Healthcare Insurance Database
|
||
Completed |
NCT02705534 -
Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1
|
Phase 3 | |
Completed |
NCT02596880 -
Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics
|
Phase 3 | |
Completed |
NCT02247414 -
Warfarin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy and Azygoportal Disconnection
|
Phase 4 | |
Completed |
NCT02016196 -
Rifaximin vs Placebo for the Prevention of Encephalopathy in Patients Treated by TIPS
|
Phase 3 | |
Withdrawn |
NCT01956864 -
Study of High-Dose Oral Vitamin D for the Prevention of Liver Cancer
|
Phase 1 | |
Completed |
NCT01362855 -
Advance Care Planning Evaluation in Hospitalized Elderly Patients
|
||
Completed |
NCT02113631 -
Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir
|
N/A | |
Completed |
NCT01447537 -
Mechanisms Involved in the Benefits of an Exercise Programme in Patients With Cirrhosis
|
N/A | |
Active, not recruiting |
NCT01205074 -
¹³C-Methacetin Breath Test (MBT) Methodology Study
|
Phase 2/Phase 3 | |
Completed |
NCT01476995 -
Prognostic Indicators as Provided by the EPIC ClearView
|
N/A | |
Completed |
NCT01231828 -
Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies.
|
N/A |