Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid

Description

The primary objective of the study is to compare the effect of daily oral administration of elafibranor 80mg and 120 mg on change in serum alkaline phosphatase (ALP) to that of placebo in patients with PBC and inadequate response to Ursodeoxycholic acid (UDCA).

Study Start Date

April, 05 2017

Estimated Completion Date

April 2018

Interventions

  • Drug: Elafibranor 80 mg
  • Drug: Elafibranor 120 mg
  • Drug: Placebo

Study ID

Genfit -- GFT505B-216-1

Status

Recruiting

Trial ID

NCT03124108

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

45

Sponsor

Genfit

Inclusion Criteria

    1. Must have provided written informed consent 2. Definite or probable PBC diagnosis as demonstrated by the presence of at least 2 of the following 3 diagnostic factors:
  • History of elevated ALP levels for at least 6 months prior to Day 0 (randomization visit)
  • Positive Anti-Mitochondrial Antibodies (AMA) titers (> 1/40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies
  • Liver biopsy consistent with PBC 3. ALP ? 1.67x upper limit of normal (ULN) 4. Taking UDCA for at least 12 months (stable dose for ? 6 months) prior to screening visit 5. Contraception: Females participating in this study must be of non-childbearing potential or must be using highly efficient contraception for the full duration of the study and for 1 month after the end of treatment.

Exclusion Criteria

    1. History or presence of other concomitant liver diseases 2. Screening CPK > ULN 3. Screening ALT or AST > 5 ULN 4. Screening total bilirubin > 2 ULN 5. Screening serum creatinine > 1.5 mg/dl 6. Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as patients with markers of kidney damage or estimated glomerular filtration rate [eGFR] of less than 60 mL/min/1.73 m2). 7. Patients with moderate or severe hepatic impairment (defined as Child-Pugh B/C) 8. Platelet count <150 X 10 3/microliter 9. Albumin <3.5 g/dL 10. Presence of clinical complications of PBC or clinically significant hepatic decompensation 11. If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating 12. Known history of human immunodeficiency virus (HIV) infection 13. Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease)

Gender

All

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (60)

Study Location Distance Name Phone Email
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Alan Bonder MD 617-632-1086 None
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Alan Bonder MD 617-632-1086 None
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Alan Bonder MD 617-632-1086 None
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Alan Bonder MD 617-632-1086 None
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Alan Bonder MD 617-632-1086 None
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Alan Bonder MD 617-632-1086 None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Daniel Pratt MD 617-724-3836 None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Daniel Pratt MD 617-724-3836 None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Daniel Pratt MD 617-724-3836 None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Daniel Pratt MD 617-724-3836 None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Daniel Pratt MD 617-724-3836 None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Daniel Pratt MD 617-724-3836 None
Northwell Health Sandra Atlas Bass Center for Liver Disease - Manhasset, New York 172.2 miles Henry C Bodenheimer MD 516-562-4664 None
Northwell Health Sandra Atlas Bass Center for Liver Disease - Manhasset, New York 172.2 miles Henry C Bodenheimer MD 516-562-4664 None
Northwell Health Sandra Atlas Bass Center for Liver Disease - Manhasset, New York 172.2 miles Henry C Bodenheimer MD 516-562-4664 None
Northwell Health Sandra Atlas Bass Center for Liver Disease - Manhasset, New York 172.2 miles Henry C Bodenheimer MD 516-562-4664 None
Northwell Health Sandra Atlas Bass Center for Liver Disease - Manhasset, New York 172.2 miles Henry C Bodenheimer MD 516-562-4664 None
Northwell Health Sandra Atlas Bass Center for Liver Disease - Manhasset, New York 172.2 miles Henry C Bodenheimer MD 516-562-4664 None
Virginia Commonwealth University - Richmond, Virginia 473.4 miles Velimir Luketic MD 804-828-4060 None
Virginia Commonwealth University - Richmond, Virginia 473.4 miles Velimir Luketic MD 804-828-4060 None
Virginia Commonwealth University - Richmond, Virginia 473.4 miles Velimir Luketic MD 804-828-4060 None
Virginia Commonwealth University - Richmond, Virginia 473.4 miles Velimir Luketic MD 804-828-4060 None
Virginia Commonwealth University - Richmond, Virginia 473.4 miles Velimir Luketic MD 804-828-4060 None
Virginia Commonwealth University - Richmond, Virginia 473.4 miles Velimir Luketic MD 804-828-4060 None
University of Virginia - Charlottesville, Virginia 493.4 miles Stephen H Caldwell MD 434-924-2626 None
University of Virginia - Charlottesville, Virginia 493.4 miles Stephen H Caldwell MD 434-924-2626 None
University of Virginia - Charlottesville, Virginia 493.4 miles Stephen H Caldwell MD 434-924-2626 None
University of Virginia - Charlottesville, Virginia 493.4 miles Stephen H Caldwell MD 434-924-2626 None
University of Virginia - Charlottesville, Virginia 493.4 miles Stephen H Caldwell MD 434-924-2626 None
University of Virginia - Charlottesville, Virginia 493.4 miles Stephen H Caldwell MD 434-924-2626 None
Schiff Center for Liver Diseases - Miami, Florida 1,259.8 miles Cynthia Levy MD 305-243-4615 None
Schiff Center for Liver Diseases - Miami, Florida 1,259.8 miles Cynthia Levy MD 305-243-4615 None
Schiff Center for Liver Diseases - Miami, Florida 1,259.8 miles Cynthia Levy MD 305-243-4615 None
Schiff Center for Liver Diseases - Miami, Florida 1,259.8 miles Cynthia Levy MD 305-243-4615 None
Schiff Center for Liver Diseases - Miami, Florida 1,259.8 miles Cynthia Levy MD 305-243-4615 None
Schiff Center for Liver Diseases - Miami, Florida 1,259.8 miles Cynthia Levy MD 305-243-4615 None
University of Texas Southwestern Medical Center - Dallas, Texas 1,543.9 miles Marlyn Mayo MD 214-648-2725 None
University of Texas Southwestern Medical Center - Dallas, Texas 1,543.9 miles Marlyn Mayo MD 214-648-2725 None
University of Texas Southwestern Medical Center - Dallas, Texas 1,543.9 miles Marlyn Mayo MD 214-648-2725 None
University of Texas Southwestern Medical Center - Dallas, Texas 1,543.9 miles Marlyn Mayo MD 214-648-2725 None
University of Texas Southwestern Medical Center - Dallas, Texas 1,543.9 miles Marlyn Mayo MD 214-648-2725 None
University of Texas Southwestern Medical Center - Dallas, Texas 1,543.9 miles Marlyn Mayo MD 214-648-2725 None
Baylor College of Medicine Advanced Liver Therapies - Houston, Texas 1,609.9 miles John M Vierling MD 832-355-8966 None
Baylor College of Medicine Advanced Liver Therapies - Houston, Texas 1,609.9 miles John M Vierling MD 832-355-8966 None
Baylor College of Medicine Advanced Liver Therapies - Houston, Texas 1,609.9 miles John M Vierling MD 832-355-8966 None
Baylor College of Medicine Advanced Liver Therapies - Houston, Texas 1,609.9 miles John M Vierling MD 832-355-8966 None
Baylor College of Medicine Advanced Liver Therapies - Houston, Texas 1,609.9 miles John M Vierling MD 832-355-8966 None
Baylor College of Medicine Advanced Liver Therapies - Houston, Texas 1,609.9 miles John M Vierling MD 832-355-8966 None
Mayo Clinic in Arizona - Phoenix, Arizona 2,284.5 miles Elizabeth J Carey MD 480-342-2000 None
Mayo Clinic in Arizona - Phoenix, Arizona 2,284.5 miles Elizabeth J Carey MD 480-342-2000 None
Mayo Clinic in Arizona - Phoenix, Arizona 2,284.5 miles Elizabeth J Carey MD 480-342-2000 None
Mayo Clinic in Arizona - Phoenix, Arizona 2,284.5 miles Elizabeth J Carey MD 480-342-2000 None
Mayo Clinic in Arizona - Phoenix, Arizona 2,284.5 miles Elizabeth J Carey MD 480-342-2000 None
Mayo Clinic in Arizona - Phoenix, Arizona 2,284.5 miles Elizabeth J Carey MD 480-342-2000 None
Swedish Organ Transplant and Liver Center - Seattle, Washington 2,489.6 miles Kris Kowdley MD 206-386-3880 None
Swedish Organ Transplant and Liver Center - Seattle, Washington 2,489.6 miles Kris Kowdley MD 206-386-3880 None
Swedish Organ Transplant and Liver Center - Seattle, Washington 2,489.6 miles Kris Kowdley MD 206-386-3880 None
Swedish Organ Transplant and Liver Center - Seattle, Washington 2,489.6 miles Kris Kowdley MD 206-386-3880 None
Swedish Organ Transplant and Liver Center - Seattle, Washington 2,489.6 miles Kris Kowdley MD 206-386-3880 None
Swedish Organ Transplant and Liver Center - Seattle, Washington 2,489.6 miles Kris Kowdley MD 206-386-3880 None

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