Clinical Trial: Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Clinical Phase 2 Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid

Brief Summary: This study is a placebo-controlled, randomized, double-blind, multicenter, parallel-group comparison study in primary biliary cholangitis participants inadequately responding to ursodeoxycholic acid.

Detailed Summary:
Sponsor: EA Pharma Co., Ltd.

Current Primary Outcome: Rate of change from Baseline in serum alkaline phosphatase (ALP) values at Week 12 [ Time Frame: Baseline; Week 12 ]

This assessment will be conducted as a measure of efficacy.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of participants with a decrease in ALP response rates of 15%, 20%, and 40% from Baseline [ Time Frame: Baseline; up to Week 64 ]
    This assessment will be conducted as a measure of efficacy.
  • Number of participants with an ALP value less than 1.67 times the upper limit normal and a total bilirubin value within normal limits and a greater than or equal to 15% decrease in ALP from Baseline [ Time Frame: Baseline; up to Week 64 ]
    This assessment will be conducted as a measure of efficacy.
  • Mean values of serum ALP, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) at each visit [ Time Frame: Baseline; up to Week 64 ]
    This assessment will be conducted as a measure of efficacy.
  • Mean values of gamma-guanosine-5'-triphosphate (γGTP) at each visit [ Time Frame: Baseline; up to Week 64 ]
    This assessment will be conducted as a measure of efficacy.
  • Mean values of serum total bilirubin and direct bilirubin at each visit [ Time Frame: Baseline; up to Week 64 ]
    This assessment will be conducted as a measure of efficacy.
  • Mean values of serum total bile acids at each visit [ Time Frame: Baseline; up to Week 64 ]
    This assessment will be conducted as a measure of efficacy.
  • Mean values of serum albumin at each visit [ Time Frame: Baseline; up to Week 64 ]
    This assessment will be conducted as a measure of efficacy.
  • Mean change from Baseline in serum ALP, AST, and ALT at each visit [ Time Frame: Baseline; up to Week 64 ]
    This assessment will be conducted as a measure of efficacy.
  • Mean change from Baseline in serum γGTP at each visit [ Time Frame: Baseline; up to Week 64 ]
    This assessment will be conducted as a measure of efficacy.
  • Mean change from Baseline in serum total bilirubin and direct bilirubin at each visit [ Time Frame: Baseline; up to Week 64 ]
    This assessment will be conducted as a measure of efficacy.
  • Mean change from Baseline in serum total bile acids at each visit [ Time Frame: Baseline; up to Week 64 ]
    This assessment will be conducted as a measure of efficacy.
  • Mean change from Baseline in serum albumin at each visit [ Time Frame: Baseline; up to Week 64 ]
    This assessment will be conducted as a measure of efficacy.
  • Mean rate of change from Baseline in serum ALP, AST, and ALT at each visit [ Time Frame: Baseline; up to Week 64 ]
    This assessment will be conducted as a measure of efficacy.
  • Mean rate of change from Baseline in serum γGTP at each visit [ Time Frame: Baseline; up to Week 64 ]
    This assessment will be conducted as a measure of efficacy.
  • Mean rate of change from Baseline in serum total bilirubin and direct bilirubin at each visit [ Time Frame: Baseline; up to Week 64 ]
    This assessment will be conducted as a measure of efficacy.
  • Mean rate of change from Baseline in serum total bile acids at each visit [ Time Frame: Baseline; up to Week 64 ]
    This assessment will be conducted as a measure of efficacy.
  • Mean rate of change from Baseline in serum albumin at each visit [ Time Frame: Baseline; up to Week 64 ]
    This assessment will be conducted as a measure of efficacy.
  • Mean change from Baseline in individual domain and total primary biliary cholangitis (PBC) version Child-Pugh scores [ Time Frame: Screening; up to Week 64 ]
    The Child-Pugh classification is used to assess the prognosis of chronic liver disease. The score employs five clinical measures of liver disease. Each measure is scored from 1 to 3, with 3 indicating most severe derangement. The total score ranges from 5 to 15 and is a sum of the individual domain scores. A higher score indicates a worse prognosis.
  • Mean change from Baseline in domain (Symptoms, Itch, Fatigue, Cognitive, Emotional, Social) and total scores on the PBC-40 [ Time Frame: Baseline; up to Week 64 ]
    The PBC-40 is measures quality of life. Participants are asked to respond to 40 questions, each of which is scored on a scale of 0 to 5 (where 0=not applicable; 1=least impact; 5=greatest impact), grouped into six domains (symptoms, itch, fatigue, cognition,

    Original Secondary Outcome: Same as current

    Information By: Eisai Inc.

    Dates:
    Date Received: March 24, 2017
    Date Started: March 21, 2017
    Date Completion: March 2020
    Last Updated: April 21, 2017
    Last Verified: March 2017