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Canadian Clinical Trials
Clinical Trials, PBC News  |   September 24, 2019

Canadian Clinical Trials

 PBC patients across Canada can get involved in a number of Clinical Trials.  Learn more about all of the clinical trials now underway and read details about who qualifies for
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Linerixibat (GSK2330672) granted Orphan Status
Clinical Trials, PBC News  |   September 24, 2019

Linerixibat (GSK2330672) granted Orphan Status

Linerixibat (GSK2330672), a drug that is being developed for PBC patients who experience itchiness, has recently been granted “orphan” status by the FDA.  This is wonderful news for patients who
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Phase 3 now enrolling
Clinical Trials, PBC News  |   September 23, 2019

Phase 3 now enrolling

As a result of extremely promising results of Phase 2 trials, Cymabay Therapeutics is now enrolling patients in a Phase 3 study for Seladelpar.  This is a 52 week triple
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Results of our Patient Survey
PBC News, PBC Research  |   April 4, 2019

Results of our Patient Survey

Read the results of our patient survey which was initiated in 2015, with more than 250 PBC patients reporting how PBC affects their daily lives.  We worked with a research
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Promising Interim Results for Phase 2 Trial
Clinical Trials, PBC News  |   November 6, 2018

Promising Interim Results for Phase 2 Trial

Genkyotex “published interim efficacy results today, GKT831 met both it’s primary and secondary endpoints in the Phase II PBC trial! A big thank you to the patients who participate in the
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PBC News, PBC Research  |   October 26, 2018

How do you Diagnose PBC?

The Toronto Centre for Liver Disease recently published a graphic that explains how specialists diagnose PBC.  Thanks to Dr. Gideon Hirschfield and Marwa Ismail for this concise explanation.
Download the graphic here.

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Your Liver & Cirrhosis
PBC News, PBC Research  |   October 26, 2018

Your Liver & Cirrhosis

Thanks to the Gastrointestinal Society in association with the Canadian Society of Intestinal Research for this excellent graphic describing Liver Cirrhosis and providing you with a tool to discuss your
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Phase 2 trial for PBC non-bile acid FXR agonist cancelled
Clinical Trials, PBC News  |   October 19, 2018

Phase 2 trial for PBC non-bile acid FXR agonist cancelled

Novartis has cancelled its phase II trial for a non-bile acid FXR agonist in patients with PBC.  
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Anti-depressant may help PBC
PBC News, PBC Research  |   June 23, 2018

Anti-depressant may help PBC

A new study from the University of Calgary shows the antidepressant, Mitrazapine, may help PBC. In April  Dr Abdel Aziz presented the promising results. Read more here.
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Proof of Concept clinical trial – Australia & New Zealand
Clinical Trials, PBC News  |   March 23, 2018

Proof of Concept clinical trial – Australia & New Zealand

More exciting news for PBC patients and their families. Arena Pharmaceutical is beginning a proof of concept clinical trial in Australia and New Zealand for Etrasimod. Read more.
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    9/10 patients with PBC are women 35-60 years old



    Initial assessment
    • Ultrasound should be used to exclude other causes of cholestasis.
    • Physical examination should be used to screen for hepatomegaly, splenomegaly and extrahepatic signs
    of advanced liver disease.

    Unexplained cholestasis
    • Elevated ALP but AMA-negative (<1/40)
    • Concern over, or presence of, autoimmune hepatitis

    ↓

    Additional assessments

    ↓

    If further assessments confirm PBC

    Confirmed PBC



    *Liver biopsy is rarely required for diagnosis in the correct clinical context; consider if disease-specific autoantibodies are absent, or concern over features of AIH or coexistent NAFLD.



    Disease management
    Pruritus, fatigue, sicca complex, bone density, coexistent autoimmune disease, CV risk and metabolic syndrome

     

    Assess pre-treatment disease stage and long-term risk of disease progression
    • The strongest risk factors for inadequate response to UDCA are early age at diagnosis and advanced disease stage at presentation. Other risk factors also exist for inadequate response to UDCA, including male gender (associated with more advanced disease at presentation).
    • Patients with an inadequate response to UDCA, and those with cirrhosis, are at the greatest risk of disease progression and complications from PBC.
    • Severity of symptoms does not necessarily correlate with disease stage in PBC, however, severe pruritus can indicate an aggressively ductopenic variant of PBC, which is associated with a poor prognosis.

     

    Hirschfield et al. EASL Clinical Practice Guidelines: The diagnosis and management of patients with primary biliary cholangitis. J Hepatol
    2017; 67(1): 145–172
    Zhang et al. Early biochemical response to ursodeoxycholic acid and long-term prognosis of primary biliary cirrhosis:
    results of a 14-year cohort study. Hepatology 2013; 58(1): 264–272 3. Corpechot et al. Noninvasive elastography-based assessment of liver
    fibrosis progression and prognosis in primary biliary cirrhosis. Hepatology 2012; 56(1): 198–208

     

    Assess 1st line treatment response within 6–12 months
    • Most biochemical response criteria have been validated as predicting long-term disease progression at 12 months from UDCA initiation.1 A 12-month period is conventionally used to assess biochemical response to UDCA, but it has been demonstrated that evaluation at 6 months may be equally discriminatory.
    • Elastography should be used yearly to assess liver fibrosis. Elastography has been shown as one of the best surrogate markers for the detection of cirrhosis or severe fibrosis.1 It has also been demonstrated that liver stiffness measurements (as measured by elastography) of greater than 9.6kPa are associated with a 5-fold increased risk of liver decompensation, transplantation or death.3 However, the ability of elastography to predict disease progression in PBC requires further validation.

     

    Hirschfield et al. EASL Clinical Practice Guidelines: The diagnosis and management of patients with primary biliary cholangitis. J Hepatol
    2017; 67(1): 145–172
    Zhang et al. Early biochemical response to ursodeoxycholic acid and long-term prognosis of primary biliary cirrhosis:
    results of a 14-year cohort study. Hepatology 2013; 58(1): 264–272 3. Corpechot et al. Noninvasive elastography-based assessment of liver
    fibrosis progression and prognosis in primary biliary cirrhosis. Hepatology 2012; 56(1): 198–208

     

    Abbreviated Prescribing Information
    Presentation: OCALIVA supplied as film-coated tablets containing 5 mg and 10 mg obeticholic acid.
    Indication: For the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
    Dosage and administration: Oral administration. Hepatic status must be known before initiating treatment. In patients with normal or mildly impaired (Child Pugh Class A) hepatic function, the starting dose is 5 mg once daily. Based on an assessment of tolerability after 6 months, the dose should be increased to 10 mg once daily if adequate reduction of alkaline phosphatase (ALP) and/or total bilirubin have not been achieved. No dose adjustment of concomitant UDCA is required in patients receiving obeticholic acid. For cases of severe pruritus, dose management includes reduction, temporal interruption or discontinuation for persistent intolerable pruritus; use of bile acid binding agents or antihistamines (see SmPC).
    Moderate to severe hepatic impairment: In patients with Child Pugh B or C hepatic impairment, a reduced starting dose of 5 mg once weekly is required. After 3 months, depending on response and tolerability, the starting dose may be titrated to 5 mg twice weekly and subsequently to 10 mg twice weekly (at least 3 days between doses) if adequate reductions in ALP and/or total bilirubin have not been achieved. No dose adjustment required in Child Pugh Class A function.
    Mild or moderate renal impairment: No dose adjustments are required. Paediatric population: No data. Elderly: No dose adjustment required; limited data exist. Contraindications: Hypersensitivity to the active substance or any excipients. Complete biliary obstruction. Special warnings and precautions for use: After initiation, patients should be monitored for progression of PBC with frequent clinical and laboratory assessment of those at increased risk of hepatic decompensation. Dose frequency should be reduced in patients who progress from Child Pugh A to Child Pugh B or C Class disease. Serious liver injury and death have been reported in patients with moderate/severe impairment who did not receive appropriate dose reduction. Liver-related adverse events have been observed within the first month of treatment and have included elevations in alanine amino transferase (ALT), aspartate aminotransferase (AST) and hepatic decompensation.
    Interactions: Following co-administration of warfarin and obeticholic acid, International Normalised Ratio (INR) should be monitored and the dose of warfarin adjusted, if needed, to maintain the target INR range. Therapeutic monitoring of CYP1A2 substrates with narrow therapeutic index (e.g. theophylline and tizanidine) is recommended. Obeticholic acid should be taken at least 4-6 hours before or after taking a bile acid binding resin, or at as great an interval as possible. Fertility, pregnancy and lactation: Avoid use in pregnancy. Either discontinue breast-feeding or discontinue/abstain from obeticholic acid therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. No clinical data on fertility effects. Undesirable effects: Very common (≥1/10) adverse reactions were pruritus, fatigue, and abdominal pain and discomfort. The most common adverse reaction leading to discontinuation was pruritus. The majority of pruritus occurred within the first month of treatment and tended to resolve over time with continued dosing. Other commonly (≥1/100 to <1/10) reported adverse reactions are, thyroid function abnormality, dizziness, palpitations, oropharyngeal pain, constipation, eczema, rash, arthralgia, peripheral oedema, and pyrexia. Please refer to the SmPC for a full list of undesirable effects.
    Overdose: Liver-related adverse reactions were reported with higher than recommended doses of obeticholic acid. Patients should be carefully observed, and supportive care administered, as appropriate. Legal category: POM Marketing authorisation numbers: EU/1/16/1139/001 & 002
    Marketing authorisation holder: Intercept Pharma Ltd, 2 Pancras Square, London, N1C 4AG, United Kingdom Package quantities and basic NHS cost: OCALIVA 5 mg and 10 mg £2,384.04 per bottle of 30 tablets. Date of revision: 11th April 2018