Not recruitingRare disease

Study on Pyridoxine for Patients with Primary Sclerosing Cholangitis

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for Primary Sclerosing Cholangitis (PSC), a disease that affects the bile ducts in the liver. The treatment being tested is Pyridoxine Hydrochloride, which is also known as Vitamin B6. The study aims to determine if pyridoxine is more effective than a placebo in reducing levels of a liver enzyme called alkaline phosphatase, which is often elevated in people with PSC.

Participants in the study will receive either pyridoxine or a placebo for a period of 12 weeks. After this phase, they will switch to the other treatment for another 12 weeks. This approach helps researchers compare the effects of the actual treatment against the placebo. The study will monitor changes in various health markers, including liver function tests and other indicators of liver health, to assess the impact of pyridoxine on PSC.

The trial will also evaluate the safety of pyridoxine by recording any adverse events or side effects experienced by participants. By the end of the study, researchers hope to gather enough information to understand whether pyridoxine can be a beneficial treatment option for individuals with Primary Sclerosing Cholangitis.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, language proficiency, and a confirmed diagnosis of primary sclerosing cholangitis (PSC).
A colonoscopy must have been performed at least once, and if there is a history of inflammatory bowel disease (IBD), a recent colonoscopy within the last 24 months is required.
Participants must have stable doses of any current medications for at least 12 weeks prior to the study.
Step 2
Screening
Screening involves checking alkaline phosphatase levels, which must be above the normal reference range.
Participants with autoimmune hepatitis must have stable immunosuppression for the last 12 months.
Step 3
Treatment phase 1
The first treatment phase lasts 12 weeks, during which participants receive pyridoxine hydrochloride orally.
The dosage and frequency of administration are determined by the study protocol.
Step 4
Treatment phase 2
Following the initial 12 weeks, participants enter a second 12-week phase where they receive a placebo.
The purpose is to compare the effects of pyridoxine with the placebo.
Step 5
Evaluation
Throughout the study, various health indicators are monitored, including changes in alkaline phosphatase, liver function tests, and other relevant biomarkers.
Participants' quality of life and symptoms such as fatigue and itching are assessed using specific scales.
Step 6
Open label treatment
After the placebo phase, an open label treatment phase is conducted for 24 weeks.
Participants receive 12 weeks of 40 mg pyridoxine followed by 12 weeks of 1.6 mg pyridoxine.
Step 7
Final assessment
At the end of the study, a final assessment is performed to evaluate the overall changes in health indicators and symptoms.
The study aims to determine the effectiveness of pyridoxine in reducing alkaline phosphatase levels compared to placebo.

Who can join the trial?

11 criteria

Participant must be older than 18 years and younger than 75 years at the time of signing the consent form.
Must be able to answer patient questionnaires.
Must understand Norwegian.
Participants must have a confirmed diagnosis of large-duct Primary Sclerosing Cholangitis (PSC), which is a liver disease affecting the bile ducts. This diagnosis should be verified by specific imaging tests that show changes in the bile ducts.
Alkaline phosphatase levels, a type of enzyme in the blood, must be higher than the normal limit at screening.
All participants must have had a colonoscopy, a test to check the inside of the colon, at least once. If they have Inflammatory Bowel Disease (IBD), a colonoscopy must have been done within the last 24 months before screening.
If the participant has IBD, any inflammation of the colon should be in remission or show mild activity for 12 weeks before screening.
Participants taking biologics, immunosuppressives, or corticosteroids must be on a stable dose for at least 12 weeks before screening and should continue the same medication during the study.
Participants using ursodeoxycholic acid or bezafibrate must be on a stable dose for at least 12 weeks before screening.
If the participant has autoimmune hepatitis, a stable dose of immunosuppressive medication is required for the last 12 months. This includes drugs like prednisone, budesonide, or azathioprine.
Must be able to give written informed consent, which means agreeing to follow the study's rules and requirements.

Who cannot join the trial?

6 criteria

Patients who have a different liver condition other than Primary Sclerosing Cholangitis (PSC). PSC is a disease that affects the bile ducts in the liver.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who are not able to follow the study procedures or take the study medication as required.
Patients who are currently participating in another clinical trial.
Patients who have any other medical condition that the study doctors think might interfere with the study.

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Verified sites

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Verified
Akershus University Hospital
Lorenskog, Norway
Verified
Oslo University Hospital HF
Oslo, Norway

Trial locations

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Investigated drugs

Pyridoxine is being studied for its potential benefits in treating primary sclerosing cholangitis (PSC). This condition affects the bile ducts and can lead to liver damage. The trial aims to determine if pyridoxine can help reduce levels of alkaline phosphatase, an enzyme that is often elevated in PSC patients. By lowering these levels, pyridoxine may help improve liver function and slow the progression of the disease.

Pyridoxine Hydrochloride

What is already known about the treatment

Pyridoxine – Pyridoxine, commonly known as vitamin B6, is administered orally in tablet form. It is currently being studied in clinical trials for its potential benefits in treating primary sclerosing cholangitis, a liver disease. The main therapeutic indication for pyridoxine in this context is to reduce alkaline phosphatase levels, which are often elevated in this condition. At the molecular level, pyridoxine acts as a coenzyme in various enzymatic reactions, particularly those involved in amino acid metabolism. It is classified pharmacologically as a vitamin and nutritional supplement.

Investigated diseases

Primary sclerosing cholangitis – This is a chronic liver disease characterized by inflammation and scarring of the bile ducts inside and outside the liver. Over time, the scarring can cause the bile ducts to become blocked, leading to a buildup of bile in the liver. This can result in liver damage and eventually lead to liver failure. The disease progresses slowly, and symptoms may include fatigue, itching, and jaundice. The exact cause of primary sclerosing cholangitis is unknown, but it is often associated with inflammatory bowel diseases. The progression of the disease can vary greatly among individuals.