Clinical Trials Logo

Clinical Trial Summary

This study will examine the effect of S-adenosyl methionine (SAMe) on itching and fatigue in patients with primary biliary cirrhosis, a disease of the small bile ducts in the liver. Ursodiol, the only currently available treatment for biliary cirrhosis, does not cure the disease, and many people continue to have symptoms or liver test abnormalities despite treatment. SAMe is a naturally occurring substance found in most cells of the body. The highest levels of the substance are produced by the liver, where it helps to rid the body of toxins and breakdown products of metabolism. Studies in Europe suggest that SAMe may help to: 1) decrease the fatigue and itching that are common in persons with liver problems, and 2) decrease levels of liver enzymes in the blood, suggesting that it may decrease the amount of liver injury.

Patients 21 years of age or older with primary biliary cirrhosis who are taking ursodiol and have symptoms of itching or fatigue may be eligible for this study. Candidates are screened with a medical history, physical examination, review of medical records, routine blood tests, and a symptoms rating scale.

Participants stop all medications for itching 4 weeks before starting the study, but continue to take ursodiol during the 42-week trial. On entering the study, patients are assigned to take either SAMe or placebo tablets twice a day for 12 weeks. While taking the medications, they are followed in the clinic every 2 weeks for the first month and then every 4 weeks to fill out symptoms questionnaires and have a short medical evaluation and blood tests. At the end of 12 weeks, treatment is interrupted for a 2-week "wash-out" period, after which patients begin a 12-week crossover treatment; that is, patients who were taking SAMe are switched to placebo, and those who were taking placebo are switched to SAMe.

After completing the second 12-week treatment course, patients come to the clinic at 4, 8, and 12 weeks to fill out symptoms questionnaires and have a medical evaluation and blood tests. At the last visit, patients are told which type of tablet they received during the two courses of treatment. SAMe is available without prescription in many forms as an over-the-counter medication.


Clinical Trial Description

To assess the efficacy of S-adenosyl methionine (SAMe) in symptomatic relief of primary biliary cirrhosis (PBC), we will treat up to 50 patients with either SAM-e (800 mg BID) or placebo for 12 weeks in a cross-over, double-blind placebo-controlled study.

S-adenosyl methionine is a nutritional supplement which is available as an over-the-counter formula and is used for treatment of depression and arthritic pain. SAMe is produced in virtually all cells and participates in many biochemical pathways as a major methyl contributor. Intracellular levels of SAMe are often decreased in advanced liver disease. At present SAMe is undergoing extensive evaluation in a large multicenter, randomized controlled trial as an adjunctive therapy of alcoholic liver disease. SAMe has also been evaluated in patients with intrahepatic cholestasis and cholestasis of pregnancy with promising effects of relieving pruritus and fatigue and improving serum liver associated enzymes.

In this study, we will recruit patients with PBC who have pruritus or fatigue despite therapy with ursodiol (the currently recommended therapy of PBC which is partially effective in relieving pruritus and fatigue). After medical evaluation and a brief period of monitoring, patients will be randomized to receive either SAMe or placebo given in oral form in similar appearing capsules twice daily. Patients will be followed at regular intervals for symptoms as monitored by validated questionnaires as well as for side effects and serum biochemical and hematological tests. After 12 weeks, therapy will be withdrawn for 2 weeks and patients will then be switched to the alternative capsules, either SAMe or placebo, for another 12 weeks. The primary endpoints of therapy will be improvements in symptoms of pruritus or fatigue or both. Secondary endpoints will be improvements in serum biochemical liver related enzymes. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00125281
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact
Status Terminated
Phase Phase 2
Start date July 25, 2005
Completion date July 2, 2008

See also
  Status Clinical Trial Phase
Completed NCT02917408 - Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital
Terminated NCT00550862 - Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC) Phase 2
Completed NCT00004748 - Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis Phase 3
Completed NCT03630718 - Trial of Psychoeducational and Hypnosis Interventions on the Fatigue Associated With PBC in Women N/A
Completed NCT00004842 - Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis Phase 1
Terminated NCT03633227 - Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment Phase 4
Completed NCT04629456 - Physical Therapy for Liver Cirrhosis N/A
Completed NCT03468699 - Autologous Bone Marrow Mononuclear Stem Cell for Children Suffering From Liver Cirrhosis Due to Biliary Atresia Phase 2
Completed NCT00004784 - Phase III Randomized Study of Ursodiol With Vs Without Methotrexate for Primary Biliary Cirrhosis Phase 3
Completed NCT00006168 - Ursodiol-Methotrexate for Primary Biliary Cirrhosis Phase 3
Completed NCT00570765 - Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC) Phase 2
Recruiting NCT00160940 - Differential Gene Expression of Liver Tissue and Blood From Individuals With Chronic Viral Hepatitis N/A
Recruiting NCT03146910 - Swiss Primary Biliary Cholangitis Cohort Study
Terminated NCT03265249 - BRIDGE Device for Post-operative Pain Control N/A
Terminated NCT02308111 - Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis Phase 4
Recruiting NCT02936596 - Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome N/A
Completed NCT00406237 - Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis Phase 1
Completed NCT04047160 - Safety, Tolerability of OP-724 in Patients With Primary Biliary Cholangitis (Phase I) Phase 1
Recruiting NCT00145964 - Identification of the Genetic Variants Responsible for Primary Biliary Cirrhosis (PBC) N/A
Terminated NCT03476993 - Non-comparative Study of BCD-085 in Combination With UDCA in Patients With Primary Biliary Cholangitis Phase 2