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Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis (EPICS)

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ClinicalTrials.gov Identifier: NCT03112681
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Zydus Discovery DMCC

Brief Summary:
prospective, multicenter, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability and efficacy of saroglitazar magnesium 2 mg, 4 mg in Patients with Primary Biliary Cholangitis. A total 36 subjects will be enrolled in a ratio of 1:1:1 to receive either saroglitazar magnesium 2 mg or saroglitazar magnesium 4 mg or placebo.

Condition or disease Intervention/treatment Phase
Primary Biliary Cirrhosis Drug: Saroglitazar magnesium 2 mg Drug: Saroglitazar magnesium 4 mg Drug: Placebo Oral Tablet Phase 2

Detailed Description:

Study SARO.16.004.02 is a prospective, multicenter, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability and efficacy of saroglitazar magnesium 2 mg, 4 mg in Patients with Primary Biliary Cholangitis.

A total 36 subjects will be enrolled in a ratio of 1:1:1 to receive either saroglitazar magnesium 2 mg or saroglitazar magnesium 4 mg or placebo. The primary objective is to investigate the effect of a 16-week treatment regimen of Saroglitazar magnesium 2 mg and 4 mg on ALP levels in patients with Primary Biliary Cholangitis.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: A Phase 2, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Magnesium in Patients With Primary Biliary Cholangitis (EPICS )
Actual Study Start Date : August 18, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : November 2019


Arm Intervention/treatment
Experimental: Saroglitazar magnesium 2 mg
Saroglitazar magnesium 2 mg tablet Once daily for 16 weeks
Drug: Saroglitazar magnesium 2 mg
Saroglitazar magnesium 2 mg once daily in the morning before breakfast without food, for a period of 16 weeks.
Other Name: Not any

Experimental: Saroglitazar magnesium 4 mg
Saroglitazar magnesium 4 mg tablet Once daily for 16 weeks
Drug: Saroglitazar magnesium 4 mg
Saroglitazar magnesium 4 mg once daily in the morning before breakfast without food, for a period of 16 weeks.
Other Name: Not any

Placebo Comparator: Placebo
Placebo tablet Once daily for 16 weeks
Drug: Placebo Oral Tablet
Placebo once daily in the morning before breakfast without food, for a period of 16 weeks.
Other Name: Not any




Primary Outcome Measures :
  1. Effect of a 16-week treatment regimen of Saroglitazar magnesium 2 mg and 4 mg on ALP levels in patients with Primary Biliary Cholangitis. [ Time Frame: 16 Weeks ]
    Improvement in ALP levels after 16 weeks of Saroglitazar magnesium 2 mg and 4 mg treatment.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females, between 18 and 75 years of age, inclusive.
  2. a) Patients on therapeutic doses of Ursodeoxycholic acid (UDCA) for ≥12 months and stable therapy for ≥3 months prior to enrolment.

    OR b) Patients who are unable to tolerate UDCA, and did not receive UDCA for at least 3 months from the date of screening.

  3. History of confirmed Primary Biliary Cholangitis Diagnosis, based on American Association for the Study of Liver Disease [AASLD] and European Association for Study of the Liver [EASL] Practice Guidelines; [Lindor 2009; EASL 2009], as demonstrated by the presence of at least≥2 of the following 3 diagnostic factors:

    • History of elevated Alkaline Phosphatase levels for at least 6 months prior to Screening Visit 1
    • Positive antimitochondrial antibodies (AMA) titer or if AMA negative or in low titer (<1:80) PBC specific antibodies (anti-GP210 and/or anti-SP100 and/or antibodies against the major M2 components [PDC-E2, 2-oxo-glutaric acid dehydrogenase complex])
    • Liver biopsy consistent with PBC.
  4. ALP ≥1.67x upper limit of normal (ULN) at Visit 1 and Visit 2 and with < 30% variance between the levels from Visit 1 to Visit 2.
  5. Contraception: Female patients must be postmenopausal, surgically sterile, or if premenopausal, agree to use ≥ 1 effective method of contraception during the trial. Effective methods of contraception are considered to be Hormonal (e.g., contraceptive pill, patch, intramuscular implant or injection); or Double barrier method, i.e., (a) condom (male or female) or (b) diaphragm, with spermicide; or Intrauterine device (IUD); or Vasectomy (partner).
  6. Must provide written informed consent and agree to comply with the trial protocol.

Exclusion Criteria:

  1. Consumption of >3 units of alcohol per day (>21 units per week) if male and >2 units of alcohol per day (>14 units per week) if female for at least 3 consecutive months in the last 5 years (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor).
  2. History or presence of other concomitant liver diseases including:

    • Hepatitis B or C virus (HCV, HBV) infection
    • Primary sclerosing cholangitis (PSC)
    • Alcoholic liver disease
    • Definite autoimmune liver disease or overlap syndrome
    • Non-alcoholic steatohepatitis (NASH)
  3. Cirrhosis with complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma, bilirubin > 2x ULN, ascites, encephalopathy, known esophageal varices or history of variceal bleeding and active or history of hepatorenal syndrome.
  4. History of any venous thromboembolism, TIA, intracranial hemorrhage, neoplasm, arteriovenous malformation, vasculitis, bleeding disorder, coagulation disorders or screening blood tests that indicate altered coagulability (e.g. platelet count, aPTT, PTT or TT tests).
  5. Patients with INR > ULN at visit 1.
  6. Patients with total bilirubin > ULN at visit 1 that is not due to Gilbert's syndrome
  7. Patients with >30% increase in ALT, total bilirubin, or INR between Visit 1 to Visit 2.
  8. Patients with serum creatinine >ULN according to the gender at Visit 1.
  9. Patients with abnormal total creatine kinase (CK) OR lipase OR amylase at Visit 1.
  10. Unstable cardiovascular disease, including:

    • unstable angina, (i.e., new or worsening symptoms of coronary heart disease within the past 3 months), acute coronary syndrome within the past 6 months, acute myocardial infarction in the past 3 months or heart failure of New York Heart Association class (III - IV) or worsening congestive heart failure, or coronary artery intervention, within the past 6 months
    • history of (within prior 3 months) or current unstable cardiac dysrhythmias
    • uncontrolled hypertension (systolic blood pressure [BP] >160 mmHg and/or diastolic BP >100 mmHg)
    • stroke or transient ischemic attack within the prior 6 months
  11. History of malignancy in the past 5 years and/or active neoplasm with the exception of resolved superficial nonmelanoma skin cancer.
  12. Contraindications to Saroglitazar magnesium or has any conditions affecting the ability to evaluate the effects of Saroglitazar magnesium.
  13. Known allergy, sensitivity or intolerance to the study drug, comparator or formulation ingredients.
  14. Participation in any other clinical study within the previous 3 months of screening.
  15. Illicit substance abuse within the past 6 months.
  16. History or other evidence of severe illness or any other conditions that would make the patient, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, human immunodeficiency virus (HIV), coronary artery disease or active gastrointestinal conditions that might interfere with drug absorption).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112681


Contacts
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Contact: Farheen Shaikh +971556207901 farheen.arifahmed@zydusdiscovery.ae

Locations
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United States, California
California Liver Research Institute Recruiting
Pasadena, California, United States, 91105
Contact: Ms. Ligia Rosas    626-795-5769    ligia.rosas@caliverresearch.org   
Contact: Ms. Minie Mercado    626-795-5769    minie.mercado@caliverreasearch.org   
Principal Investigator: Edward Mena, MD         
United States, Florida
Schiff Center for Liver Diseases/University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Maria Onate-Silva (Lourdes)    305-243-6939    malourdeso@med.miami.edu   
Principal Investigator: Cynthia Levy, MD         
United States, Georgia
Gastrointestional Specialists of Georgia Recruiting
Marietta, Georgia, United States, 30060
Contact: Ms. Aja Bowser    678-741-5000    abowser@gigeorgia.com   
Contact: Ms. Valerie Platt    678-819-4217    vplatt@gigeorgia.com   
Principal Investigator: Aasim Sheikh, MD         
United States, Indiana
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Ms. Mandy Cruz    317-278-6215    mandcruz@iu.edu   
Contact: Ms. Wendy Morlan    269-599-5125    wmarle23@yahoo.com   
Principal Investigator: Raj Vuppalanchi, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Ms. Jenna Penterics    734-764-4911    jpentrics@med.umich.edu   
Contact: Ms. Elizabeth Wu    734-764-4911    elizwu@med.umich.edu   
Principal Investigator: Frederick Askari, MD         
United States, New Jersey
Rutgers NJ Medical School Recruiting
Newark, New Jersey, United States, 07101
Contact: Kareen Moore    973-972-0130    km1285@njms.rutgers.edu   
Principal Investigator: Nick Pyrsopoulos, MD         
United States, New York
Sandra Atlas Bass Center for Liver Diseases- Northwell Health Withdrawn
Manhasset, New York, United States, 11030
Mount Sinai Withdrawn
New York, New York, United States, 10029
NY Presbyterian-Columbia Withdrawn
New York, New York, United States, 10032
Center for Liver Diseases; New York Methodist Hospital Withdrawn
New York, New York, United States, 11215
United States, North Carolina
The University of North Carolina at Chapel Hill Withdrawn
Chapel Hill, North Carolina, United States, 27599
Carolinas Healthcare System Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Ms. Elise Shuman    704-446-4835    Elise.Shuman@atriumhealth.org   
Principal Investigator: Andrew deLemos, MD         
United States, Ohio
Consultants for Clinical Research Recruiting
Cincinnati, Ohio, United States, 45249
Contact: Rebecca Hogan    513-872-4549    RHogan@ccrstudy.com   
Contact: Amy Williams    513-872-4549    AWilliams@ccrstudy.com   
Principal Investigator: Ravi Ravinuthala, MD, FAASLD         
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Maureen McCauley    215-746-2575    maureen.mccauley2@uphs.upenn.edu   
Principal Investigator: David Goldberg, MD         
Einstein Medical Center Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19141
Contact: Mrs. Marva James    215-456-2004    jamesmar@einstein.edu   
Principal Investigator: Simona Rossi, MD         
Sponsors and Collaborators
Zydus Discovery DMCC
Investigators
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Study Director: Deven Parmar, MD FACP FCP Zydus Discovery DMCC

Publications of Results:
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Responsible Party: Zydus Discovery DMCC
ClinicalTrials.gov Identifier: NCT03112681     History of Changes
Other Study ID Numbers: SARO.16.004.05.PROT
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangitis
Liver Cirrhosis, Biliary
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Cholestasis
Liver Diseases
Liver Cirrhosis