About Clinical Trials

What is a Clinical Trial?

Clinical trials are research studies involving human volunteers to see how safe and effective a potential medication is in preventing, treating, or curing a particular disease or condition. Such trials are essential research tools for advancing medical knowledge and patient care.

Just about every medication, medical device, or surgical procedure has undergone rigorous clinical studies before being approved for use.

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Why Join a Clinical Trial?

There are substantial benefits to volunteering to be in a clinical trial.

Access to medical treatment not available elsewhere

Belapectin may prevent varices and improve your overall outcome

Help advance research on NASH cirrhosis

Your participation will better the lives of others who develop NASH cirrhosis

Medication and care is free of charge

Study-related medication and care is administered free of charge

Increased monitoring of your disease

Increased monitoring of your disease and medical status may detect emerging medical issues earlier

Clinical trials can also have risks.

The medication may not help you

The trial is meant to prove whether a medication is effective. Some trials fail

There may be side effects

While every effort is taken to ensure patient safety, there are always risks in trying a new medication

You may receive the placebo

Some participants will receive a placebo, a substance that has no active ingredients and no expected medical benefit

You have a two out of three chance of receiving the drug. Even if you receive the placebo, you may still benefit from the other medical care you receive while a participant in the trial.

You should speak to your doctor to learn about the risks and benefits of any clinical trial before making the decision to participate.

What are the Phases of a Clinical Trial?

Clinical trials are characterized by Phases, with each phase dictating the goals of the study and the type of subjects or patients that will participate.

Pre-Clinical

Drug discovery and testing, in animals and test tubes

Phase 1

Safety evaluation in healthy subjects

Phase 2

Safety and efficacy in NASH cirrhosis patients

Phase 3

Confirmation of safety and efficacy in a larger group of NASH cirrhosis patients

Approval

Medication approved; research continues

The NAVIGATE Study is a seamless Phase 2b/3 trial, meaning that it will begin by supporting the potential benefits of the drug and the optimal dosage, then it will add additional participants and move into a larger trial to confirm safety and efficacy.

How Do Clinical Trials Work?

Every clinical trial has a clear goal, a well-defined protocol, and guidelines on who is eligible to participate. Investigational medications like belapectin are evaluated for safety and efficacy, generally in comparison with a placebo (a substance that has no medical effect).

Patients are randomly assigned to receive either the drug or the placebo. In a double blind trial such as the NAVIGATE Study, neither the patient nor the medical staff know which of the two the patient is receiving.

Participating in a clinical trial can provide early access to potential new treatments, but trials are not without their risks. Talk to your doctor about whether participating in the NAVIGATE Study is right for you.

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