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Galectin Inhibitor
Belapectin for NASH Cirrhosis (NAVIGATE Trial)
Verified Trial
Phase 2 & 3
Waitlist Available
Research Sponsored by Galectin Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Is male or female, ≥ 18 and ≤ 75 years of age at the time of Screening.
spleen size ≥14 cm (documented by ultrasound, MRI, or CT scan)
Timeline
Screening 10 weeks
Treatment 156 weeks
Follow Up at 78 weeks [18 months]
Awards & highlights
NAVIGATE Trial Summary
This trial will assess if belapectin is effective, safe, and tolerated in patients with NASH cirrhosis and clinical signs of portal hypertension.
Who is the study for?
Adults aged 18-75 with NASH cirrhosis and signs of portal hypertension but no esophageal varices. They must have certain liver stiffness, blood work results, and agree to use contraception if fertile. Excluded are those with recent drug abuse, certain other liver diseases, major surgery or organ transplants within specific time frames.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of Belapectin against a placebo in preventing esophageal varices in patients with NASH cirrhosis. It's a two-stage study where participants are randomly assigned to receive either Belapectin or a placebo.See study design
What are the potential side effects?
While the side effects for Belapectin aren't specified here, typical medication risks may include allergic reactions, gastrointestinal issues like nausea or diarrhea, fatigue, headaches, and potential liver-related complications.
NAVIGATE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
Select...
My spleen is larger than 14 cm as shown by an imaging test.
Select...
I have abnormal blood vessels in my abdomen confirmed by a scan or physical exam.
Select...
My liver biopsy shows cirrhosis caused by fatty liver disease, with no other cause.
Select...
I am between 18 and 75 years old.
NAVIGATE Trial Timeline
Screening ~ 10 weeks2 visits
Treatment ~ 156 weeks80 visits
Follow Up ~ at 78 weeks [18 months]
Screening ~ 10 weeks
Treatment ~ 156 weeks
Follow Up ~at 78 weeks [18 months]
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients in the belapectin treatment groups who develop new esophageal varices at 78 weeks [18 months] of treatment compared to placebo
Secondary outcome measures
Efficacy: Cumulative incidence rate of patients in the belapectin Phase 3 treatment group who progress to large varices (gastric or esophageal) or develop red wales compared to placebo.
Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop clinically significant ascites requiring hospitalization
Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop hepatic encephalopathy (West Haven score ≥2 and requiring hospitalization)
+15 moreOther outcome measures
Exploratory Efficacy: Difference in Chronic Liver Disease Questionnaire (CLDQ) scores between belapectin and placebo treatment during Phase 2b and Phase 3
Exploratory Efficacy:Change in liver stiffness measurement (LSM), baseline-adjusted, as determined by vibration controlled transient elastography (VCTE) (FibroScan) exams during Phase 2b and Phase 3
Safety: Incidence of adverse events
NAVIGATE Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: belapectin 4 mg/kg lean body mass (LBM)Experimental Treatment1 Intervention
Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months)
Phase 3: The patient will be switched to the optimal dose
Group II: belapectin 2 mg/kg lean body mass (LBM)Experimental Treatment1 Intervention
Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months)
Phase 3: The patient will be switched to the optimal dose
Group III: PlaceboPlacebo Group1 Intervention
Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months)
Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
belapectin
2020
Completed Phase 1
~40
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Galectin Therapeutics Inc.Lead Sponsor
11 Previous Clinical Trials
370 Total Patients Enrolled
2 Trials studying Liver Cirrhosis
192 Patients Enrolled for Liver Cirrhosis
Pol Boudes, M.D.Study DirectorGalectin Therapeutics Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have abnormal blood vessels in my abdomen confirmed by a scan or physical exam.My liver biopsy shows cirrhosis caused by fatty liver disease, with no other cause.I have a liver condition with cirrhosis and no other liver disease causes, plus obesity, high blood pressure, diabetes, or abnormal blood fats.I do not have liver cancer, as confirmed by recent scans.You have liver disease that is not caused by NASH.My kidney function is reduced, with a filtration rate under 45 mL/min.You have taken part in a new drug research study within the past 30 days or 5 half-lives, whichever is longer.You have a significant medical condition that could make it difficult for you to participate in the study, according to the investigator's judgement. This could include issues with your blood, kidneys, liver, lungs, brain, mental health, digestion, immune system, hormones, or other organs/systems in your body.I have been taking a statin medication regularly for at least 3 months.You drink too much alcohol regularly, more than 1-2 drinks per day for women and 2-3 drinks per day for men.I have or developed signs of worsening liver cirrhosis.Your platelet count is less than 150,000 cells per cubic millimeter of blood.I have been taking vitamin E or pioglitazone regularly for the last 3 months.I have serious heart or blood vessel problems.I have had major surgery recently.I have been diagnosed with NASH cirrhosis.I have had an organ transplant and am on immunosuppressive drugs.I have been on a stable blood pressure medication regimen for at least 3 months.I have Alpha-1 antitrypsin deficiency.I had weight loss surgery within the last year or plan to during the study.My diabetes is under control with stable medication for 3+ months, and my HbA1c is ≤9.5%.I agree not to donate sperm during and for 3 months after the study.I have varices in my esophagus or stomach confirmed by an upper GI exam.I have had or am planning to have a liver transplant.I have HIV or tested positive for HIV.I haven't had cancer in the last 5 years, except for skin or treated cervical cancer.I have received belapectin treatment within the last 6 months.You have a history of drug abuse or addiction within the last 5 years.I am between 18 and 75 years old.My spleen is larger than 14 cm as shown by an imaging test.Your liver has a stiffness score of 20 kPa or higher as measured by a FibroScan test.Your liver is not functioning properly, as indicated by the AST/ALT ratio being greater than 1.I am between 18 and 75 years old.I have signs of high blood pressure in the liver veins.I have had a procedure to connect two veins in my liver.You are allergic to the study drug or any of its ingredients.You understand the study and agree to participate by signing a form that says you agree to take part.You have a documented measurement of high blood pressure in your liver (HVPG) that is greater than 6 mmHg.
Research Study Groups:
This trial has the following groups:- Group 1: belapectin 2 mg/kg lean body mass (LBM)
- Group 2: belapectin 4 mg/kg lean body mass (LBM)
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 10 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 156 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Liver Cirrhosis Patient Testimony for trial: Trial Name: NCT04365868 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have other researchers done similar work to this before?
"There have been a total of 2 clinical trials for belapectin. The first trial occurred in 2016 and was completed in the Phase 1 drug approval stage. In the 4 years since then, 18281 additional trials have concluded."
Answered by AI
Are the patients in this test group restricted to a certain age limit?
"This trial is only for individuals aged 18-75. There are 110 other clinical trials ongoing for people under the age of majority and 640 for seniors."
Answered by AI
Can patients participate in this research at this time?
"The most recent information available from clinicaltrials.gov reports that this trial is still open and recruiting patients. The listing for this study was first posted on June 22nd, 2020 with the last update being made on November 15th, 2022."
Answered by AI
How many research facilities are controlling this experiment?
"Presently, there are 71 sites enrolling patients for this study. A few locations where these clinics can be found include Germantown, Little Rock and Ocoee. It would be advantageous to choose the closest site to avoid having to travel long distances."
Answered by AI
If I wanted to sign up for this experiment, would that be possible?
"This trial is looking for 1010 people aged 18 to 75 who are at risk for esophageal varices. Candidates must meet the following requirements: They must be male or female, and ≥18 and ≤75 years of age at the time of screening. They must also be willing and able to provide written informed consent prior to any study-specific procedures being initiated. Additionally, they must have a documented HVPG measurement >6 mmHg, spleen size ≥14 cm (as documented by ultrasound, MRI, or CT scan), abdominal collateral circulation (as documented by ultrasound, MRI, or CT scan or"
Answered by AI
How does this new clinical trial with belapectin compare to others?
"There are 2 ongoing studies for belapectin, 1 of which is in its final Phase 3. Although the majority of research surrounding this treatment is based in Nice, Tennessee, there are a total of 146 trial sites across the globe."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
Texas
Pennsylvania
Other
How old are they?
18 - 65
What site did they apply to?
Loyola University Health System
Galen Medical Group - Ziegler Plaza
Baylor College of Medicine - Baylor Clinic - Abdominal Transplant & Liver Disease Clinic
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Hep c treated 2016. I have recently been diagnosed with liver disease. Clinical trials are a great way to help bring about medical solutions and advance work toward a cure.
PatientReceived no prior treatments
I do have liver cirrhosis n I want to really try anything that will at least help me live a lot longer my phone number has changed it's 7209690448.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long is the study?
PatientReceived 2+ prior treatments
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