RECRUITING

Open-Label Extension Study of Saroglitazar Magnesium in Participants with Primary Biliary Cholangitis

Conditions

Primary Biliary Cholangitis Saroglitazar Magnesium PBC

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis

Official Title

A Multicenter, Open-Label, Extension Clinical Trial to Evaluate Safety and Efficacy of Saroglitazar Magnesium in Participants with Primary Biliary Cholangitis (PBC)

Quick Facts

Study Start:2024-07-16

Study Completion:2027-07-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06427395

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Must provide written informed consent and agree to comply with the trial protocol 2. Participated and completed SARO.21.001, the double-blind treatment phase study	1. Consumption of 2 standard drinks per day if male and 1 standard drink per day if female for 3 consecutive months (12 consecutive weeks) throughout double-blind phase till screening. 2. Participants with MELD 3.0 score of 15 or greater 3. History or presence of other concomitant liver diseases at screening: 1. Chronic hepatitis B or C virus (HBV, HCV) infection 2. Primary sclerosing cholangitis (PSC) 3. Alcoholic liver disease 4. Autoimmune hepatitis (AIH)-PBC overlap syndrome 5. Hemochromatosis 6. Non-alcoholic steatohepatitis (NASH) on historical biopsy 4. Cirrhosis with complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma, uncontrolled ascites, encephalopathy, history of variceal bleeding or history of hepatorenal syndrome at screening. 5. Use of Thiazolidinediones or Fibrates (within 12 weeks prior to screening) 6. Use of other PPAR agonists (i.e., Elafibranor, Seladelpar), Obeticholic acid (OCA), methotrexate, budesonide and other systemic corticosteroids (Prednisone dose more than 10 mg); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid, or nitrofurantoin) (within 12 weeks prior to screening) 7. History of bowel surgery (gastrointestinal \[bariatric\] surgery in the preceding 1 year or undergoing evaluation for gastrointestinal surgery (bariatric surgery for obesity, extensive small-bowel resection) or orthotopic liver transplant (OLT) or listed for OLT 8. Unstable cardiovascular disease, including: 1. Unstable angina, (i.e., new or worsening symptoms of coronary heart disease in the 12 weeks before screening and throughout the screening period), acute coronary syndrome in the 24 weeks before screening and throughout the screening period, acute myocardial infarction in the 12 weeks before screening and throughout the screening period or heart failure of New York Heart Association class (III - IV) or worsening congestive heart failure, or coronary artery intervention, in the 24 weeks before screening and throughout the screening period 2. History/current unstable cardiac dysrhythmias 3. Uncontrolled hypertension at screening 4. Stroke or transient ischemic attack in the 24 weeks before screening 9. History of intracranial hemorrhage, arteriovenous malformation, bleeding disorder, and coagulation disorders 10. An uncontrolled thyroid disorder 1. Uncontrolled hyperthyroidism: defined as any history of hyperthyroidism that has either not been treated with either radioactive iodine and/or surgery or that has been treated with radioactive iodine and/or surgery, but has required ongoing continuous or intermittent use of thyroid hormone synthesis inhibitors (i.e., methimazole or propylthiouracil) in the 24 weeks before screening 2. Uncontrolled hypothyroidism: defined as initiation of thyroid hormone replacement therapy or dose adjustment of replacement therapy in the 12 weeks before screening 11. History of myopathies or evidence of active muscle disease demonstrated by CPK ≥ 5 × ULN at screening 12. Any of the following laboratory values: 1. Total bilirubin \> 3 x ULN 2. Platelets \< 50 × 103/mL 3. Albumin \< 2.8 g/dL 4. eGFR \< 45 mL/min/1.73 m2 5. ALT or AST \> 250 U/L 6. ALP \> 10 × ULN 13. Participation in another interventional clinical study and receipt of any other investigational medication or medical device within 30 days or within 5 half-lives, whatever is longer, prior to screening 14. History of malignancy in the past 5 years and/or active neoplasm which may diminish life expectancy (except resolved superficial non-melanoma skin cancer, carcinomas in situ or other stable, relatively benign conditions if appropriately treated prior to screening) 15. Known allergy, sensitivity or intolerance to the study medication or formulation ingredients 16. Pregnancy-related exclusions, including: 1. Pregnant/lactating female (including positive pregnancy test at screening) 2. Participants agree to avoid pregnancy either by true abstinence or the use of an acceptable effective contraceptive measures for the duration of the study and for at least 1 month after the end of the study medication. Refer Appendix 9 Contraceptive Guidance. 17. History or other evidence of severe illness or any other conditions that would make the participant, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, HIV, coronary artery disease or active gastrointestinal conditions that might interfere with drug absorption) 18. Cirrhosis with Child-Pugh-Turcotte (CPT) class B or C having score of 7 or above at screening (Refer Appendix 11

Inclusion Criteria

Exclusion Criteria

1. Must provide written informed consent and agree to comply with the trial protocol
2. Participated and completed SARO.21.001, the double-blind treatment phase study

1. Consumption of 2 standard drinks per day if male and 1 standard drink per day if female for 3 consecutive months (12 consecutive weeks) throughout double-blind phase till screening.
2. Participants with MELD 3.0 score of 15 or greater
3. History or presence of other concomitant liver diseases at screening:
1. Chronic hepatitis B or C virus (HBV, HCV) infection
2. Primary sclerosing cholangitis (PSC)
3. Alcoholic liver disease
4. Autoimmune hepatitis (AIH)-PBC overlap syndrome
5. Hemochromatosis
6. Non-alcoholic steatohepatitis (NASH) on historical biopsy
4. Cirrhosis with complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma, uncontrolled ascites, encephalopathy, history of variceal bleeding or history of hepatorenal syndrome at screening.
5. Use of Thiazolidinediones or Fibrates (within 12 weeks prior to screening)
6. Use of other PPAR agonists (i.e., Elafibranor, Seladelpar), Obeticholic acid (OCA), methotrexate, budesonide and other systemic corticosteroids (Prednisone dose more than 10 mg); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid, or nitrofurantoin) (within 12 weeks prior to screening)
7. History of bowel surgery (gastrointestinal \[bariatric\] surgery in the preceding 1 year or undergoing evaluation for gastrointestinal surgery (bariatric surgery for obesity, extensive small-bowel resection) or orthotopic liver transplant (OLT) or listed for OLT
8. Unstable cardiovascular disease, including:
1. Unstable angina, (i.e., new or worsening symptoms of coronary heart disease in the 12 weeks before screening and throughout the screening period), acute coronary syndrome in the 24 weeks before screening and throughout the screening period, acute myocardial infarction in the 12 weeks before screening and throughout the screening period or heart failure of New York Heart Association class (III - IV) or worsening congestive heart failure, or coronary artery intervention, in the 24 weeks before screening and throughout the screening period
2. History/current unstable cardiac dysrhythmias
3. Uncontrolled hypertension at screening
4. Stroke or transient ischemic attack in the 24 weeks before screening
9. History of intracranial hemorrhage, arteriovenous malformation, bleeding disorder, and coagulation disorders
10. An uncontrolled thyroid disorder
1. Uncontrolled hyperthyroidism: defined as any history of hyperthyroidism that has either not been treated with either radioactive iodine and/or surgery or that has been treated with radioactive iodine and/or surgery, but has required ongoing continuous or intermittent use of thyroid hormone synthesis inhibitors (i.e., methimazole or propylthiouracil) in the 24 weeks before screening
2. Uncontrolled hypothyroidism: defined as initiation of thyroid hormone replacement therapy or dose adjustment of replacement therapy in the 12 weeks before screening
11. History of myopathies or evidence of active muscle disease demonstrated by CPK ≥ 5 × ULN at screening
12. Any of the following laboratory values:
1. Total bilirubin \> 3 x ULN
2. Platelets \< 50 × 103/mL
3. Albumin \< 2.8 g/dL
4. eGFR \< 45 mL/min/1.73 m2
5. ALT or AST \> 250 U/L
6. ALP \> 10 × ULN
13. Participation in another interventional clinical study and receipt of any other investigational medication or medical device within 30 days or within 5 half-lives, whatever is longer, prior to screening
14. History of malignancy in the past 5 years and/or active neoplasm which may diminish life expectancy (except resolved superficial non-melanoma skin cancer, carcinomas in situ or other stable, relatively benign conditions if appropriately treated prior to screening)
15. Known allergy, sensitivity or intolerance to the study medication or formulation ingredients
16. Pregnancy-related exclusions, including:
1. Pregnant/lactating female (including positive pregnancy test at screening)
2. Participants agree to avoid pregnancy either by true abstinence or the use of an acceptable effective contraceptive measures for the duration of the study and for at least 1 month after the end of the study medication. Refer Appendix 9 Contraceptive Guidance.
17. History or other evidence of severe illness or any other conditions that would make the participant, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, HIV, coronary artery disease or active gastrointestinal conditions that might interfere with drug absorption)
18. Cirrhosis with Child-Pugh-Turcotte (CPT) class B or C having score of 7 or above at screening (Refer Appendix 11

Contacts and Locations

Study Contact

Farheen Shaikh

CONTACT

609-730-1900

fshaikh@zydustherapeutics.com

Deven Parmar

CONTACT

609-559-0765

dparmar@zydustherapeutics.com

Principal Investigator

Deven Parmar

STUDY_DIRECTOR

Zydus Therapeutics Inc.

Study Locations (Sites)

Zydus US007

Birmingham, Alabama, 35294

United States

Zydus US013

Los Angeles, California, 90048

United States

Zydus US011

Pasadena, California, 91105

United States

Zydus US043

Sacramento, California, 95817

United States

Zydus US022

Aurora, Colorado, 80045

United States

Zydus US037

New Haven, Connecticut, 06520

United States

Zydus US027

Jacksonville, Florida, 32224

United States

Zydus US006

Lakewood Ranch, Florida, 34211

United States

Zydus US005

Miami, Florida, 33136

United States

Zydus US020

Marietta, Georgia, 30060

United States

Zydus US001

Indianapolis, Indiana, 46202

United States

Zydus US035

Rochester, New York, 14642

United States

Zydus US002

Charlotte, North Carolina, 28204

United States

Zydus US015

Philadelphia, Pennsylvania, 19141

United States

Zydus US004

Houston, Texas, 77030

United States

Zydus US042

Houston, Texas, 77030

United States

Zydus US031

Murray, Utah, 84107

United States

Zydus US016

Charlottesville, Virginia, 22908

United States

Zydus US039

Richmond, Virginia, 23298

United States

Zydus US033

Seattle, Washington, 98105

United States

Collaborators and Investigators

Sponsor: Zydus Therapeutics Inc.

Deven Parmar, STUDY_DIRECTOR, Zydus Therapeutics Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-16

Study Completion Date2027-07-18

Study Record Updates

Study Start Date2024-07-16

Study Completion Date2027-07-18

Terms related to this study

Keywords Provided by Researchers

Saroglitazar Magnesium
Primary Biliary Cholangitis
PBC

Additional Relevant MeSH Terms

Primary Biliary Cholangitis