Status:
TERMINATED
Safety, Tolerability and Pharmacodynamics of SYNB1020
Lead Sponsor:
Synlogic
Conditions:
Cirrhosis
Eligibility:
All Genders
18-74 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
In Part 1, a sentinel open-label cohort of subjects with cirrhosis and Model for End-Stage Liver Disease (MELD) score \<12 was admitted to an inpatient facility for a run-in diet, baseline assessments...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
March 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2019
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03447730
Start Date
March 19 2018
End Date
July 19 2019
Last Update
May 13 2021
Active Locations (5)
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1
Southern California Research Center
Coronado, California, United States, 92118
2
Inland Empire Liver Foundation
Rialto, California, United States, 92377
3
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
4
Texas Liver Institute
San Antonio, Texas, United States, 78006