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A3907

A3907 is an investigational drug being studied for the treatment of Primary Sclerosing Cholangitis (PSC), a chronic liver disease. This article discusses an open-label, Phase 2 clinical trial designed to assess the safety, tolerability, and effects of A3907 in adults with PSC. The study aims to evaluate different dosages of A3907 and its impact on bile acid levels, liver enzymes, and other relevant biomarkers in patients with PSC.

Table of Contents

What is A3907?

A3907 is a new medication being developed to treat Primary Sclerosing Cholangitis (PSC), a chronic liver disease. It is currently undergoing clinical trials to evaluate its safety and effectiveness[1]. A3907 is taken orally as a film-coated tablet, making it convenient for patients to use[1].

Primary Sclerosing Cholangitis (PSC)

Primary Sclerosing Cholangitis (PSC) is a chronic liver disease that affects the bile ducts. Bile ducts are tubes that carry bile (a digestive fluid) from the liver to the small intestine. In PSC, inflammation causes scarring and narrowing of these ducts, which can lead to liver damage over time[1].

How A3907 Works

A3907 is a type of medication called an ASBT inhibitor. ASBT stands for Apical Sodium Bile Acid Transporter. This medication works by:

  • Inhibiting (blocking) the ASBT, which is responsible for transporting bile acids
  • Lowering bile acid levels in the body
  • Modulating (changing) bile acid transport within the bile ducts
By doing this, A3907 might help reduce liver cell damage in diseases like PSC where there’s a problem with bile flow (cholestatic liver diseases)[1].

Ongoing Clinical Trial

A3907 is currently being studied in a Phase 2 clinical trial. This trial is:

  • Open-label, meaning both the researchers and participants know which treatment is being given
  • Designed to evaluate the safety, tolerability, and effects of A3907 in adults with PSC
  • Testing two dose levels: 10 mg and 30 mg, taken orally once daily for 12 weeks
  • Also including a group of patients taking 30 mg twice daily
  • Including a group of PSC patients with a Clinically Relevant Stricture (CRS), which is a severe narrowing of the bile ducts
The study will last for 12 weeks, with follow-up visits to monitor the participants’ health[1].

Potential Benefits of A3907

While the full benefits of A3907 are still being studied, researchers hope it may:

  • Improve liver health in PSC patients
  • Reduce levels of liver enzymes, which can be a sign of liver damage
  • Lower bile acid levels in the body
  • Potentially slow down the progression of PSC
However, it’s important to note that these potential benefits are still being investigated in the clinical trial[1].

Eligibility Criteria for the Study

To participate in the A3907 clinical trial, patients must meet certain criteria. Some key eligibility factors include:

  • Being between 18 and 75 years old
  • Having a confirmed diagnosis of PSC for at least 6 months
  • Having elevated levels of certain liver enzymes
  • Not having certain other liver conditions or severe liver damage
  • Not being pregnant or breastfeeding
There are additional specific criteria that healthcare providers will use to determine if a patient is eligible for the study[1].

Safety and Side Effects

The primary goal of this clinical trial is to evaluate the safety and tolerability of A3907. This means researchers will be closely monitoring:

  • Any side effects that occur during the study
  • How well patients tolerate the medication
  • Any changes in liver function or other health markers
As with any new medication, there may be unknown risks or side effects. Participants in the study will be closely monitored by healthcare professionals throughout the trial[1].

It’s important to remember that A3907 is still an experimental medication. While it shows promise, more research is needed to fully understand its effects and determine if it will become an approved treatment for PSC in the future.

Aspect Details
Study Type Open-label, Phase 2 clinical trial
Drug A3907 (oral ASBT inhibitor)
Condition Primary Sclerosing Cholangitis (PSC)
Primary Objective Evaluate safety and tolerability of A3907
Secondary Objectives Assess pharmacokinetics, effects on bile acid levels, liver enzymes, and biomarkers
Dosages 10 mg and 30 mg once daily; 30 mg twice daily
Treatment Duration 12 weeks
Key Inclusion Criteria Adults 18-75, PSC diagnosis, elevated ALP, serum bile acid level > ULN
Key Exclusion Criteria Secondary sclerosing cholangitis, recent biliary intervention, liver cirrhosis

FAQ

  • What is Primary Sclerosing Cholangitis (PSC)? Primary Sclerosing Cholangitis (PSC) is a chronic liver disease characterized by inflammation and scarring of the bile ducts, which can lead to liver damage over time.
  • What is A3907 and how does it work? A3907 is an oral, systemically available inhibitor of the apical sodium bile acid transporter (ASBT). It aims to lower bile acid levels and modulate bile acid transport within the bile ducts, potentially reducing hepatic cell damage in cholestatic liver diseases like PSC.
  • What are the main objectives of this clinical trial? The main objectives are to evaluate the safety and tolerability of A3907 in PSC patients, assess its pharmacokinetics, and determine its effects on bile acid levels, liver enzymes, and biomarkers of bile acid synthesis.
  • Who is eligible to participate in this trial? Eligible participants are adults aged 18-75 with a clinical diagnosis of large-duct PSC, elevated alkaline phosphatase levels, and other specific criteria. Some patients with a clinically relevant biliary stricture may also be included.
  • How long does the treatment period last in this trial? The treatment period in this trial lasts for 12 weeks, with patients receiving daily doses of A3907. There is also a follow-up visit 14 days after the last dose of the study drug.

Ongoing Clinical Trials on A3907

  • Study on the Safety and Tolerability of A3907 for Adults with Primary Sclerosing Cholangitis (PSC)

    Not recruiting

    2 1 1
    Investigated drugs:
    France Italy Poland Spain

Glossary

  • Primary Sclerosing Cholangitis (PSC): A chronic liver disease characterized by inflammation and scarring of the bile ducts, which can lead to liver damage over time.
  • Apical Sodium Bile Acid Transporter (ASBT): A protein responsible for the reabsorption of bile acids in the intestine. A3907 works by inhibiting this transporter.
  • Alkaline Phosphatase (ALP): An enzyme found in various tissues, including the liver. Elevated levels can indicate liver disease or bile duct obstruction.
  • Pharmacokinetics (PK): The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body.
  • Pharmacodynamics (PD): The study of the biochemical and physiological effects of drugs on the body and the mechanisms of drug action.
  • Bile Acids: Compounds produced by the liver that aid in the digestion and absorption of fats in the small intestine.
  • Liver Enzymes: Proteins that help speed up chemical reactions in the liver. Elevated levels can indicate liver damage or disease.
  • Biomarkers: Measurable indicators of biological processes, disease states, or responses to treatment.
  • Open-Label Study: A type of clinical trial where both the researchers and participants know which treatment is being administered.
  • Clinically Relevant Stricture (CRS): A narrowing of the bile ducts that is significant enough to cause clinical symptoms or affect liver function.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-tolerability-of-a3907-for-adults-with-primary-sclerosing-cholangitis-psc/