Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
NCT ID: NCT06427395
Last Updated: 2025-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
150 participants
INTERVENTIONAL
2024-07-16
2027-07-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Saroglitazar Magnesium 1 mg
Saroglitazar Magnesium 1 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 months).
Saroglitazar Magnesium 1 mg
Saroglitazar Magnesium 1 mg will be assigned to all participants enrolled in the open label extension program
Interventions
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Saroglitazar Magnesium 1 mg
Saroglitazar Magnesium 1 mg will be assigned to all participants enrolled in the open label extension program
Eligibility Criteria
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Inclusion Criteria
2. Participated and completed SARO.21.001, the double-blind treatment phase study
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Zydus Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Deven Parmar
Role: STUDY_DIRECTOR
Zydus Therapeutics Inc.
Locations
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Zydus US007
Birmingham, Alabama, United States
Zydus US013
Los Angeles, California, United States
Zydus US011
Pasadena, California, United States
Zydus US043
Sacramento, California, United States
Zydus US022
Aurora, Colorado, United States
Zydus US037
New Haven, Connecticut, United States
Zydus US027
Jacksonville, Florida, United States
Zydus US006
Lakewood Rch, Florida, United States
Zydus US005
Miami, Florida, United States
Zydus US020
Marietta, Georgia, United States
Zydus US001
Indianapolis, Indiana, United States
Zydus US035
Rochester, New York, United States
Zydus US002
Charlotte, North Carolina, United States
Zydus US015
Philadelphia, Pennsylvania, United States
Zydus US004
Houston, Texas, United States
Zydus US042
Houston, Texas, United States
Zydus US031
Murray, Utah, United States
Zydus US016
Charlottesville, Virginia, United States
Zydus US039
Richmond, Virginia, United States
Zydus US033
Seattle, Washington, United States
Zydus AR001
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Zydus AR007
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Zydus AR006
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Zydus AR005
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Zydus AR003
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Zydus AR004
Pilar, Buenos Aires, Argentina
Zydus TR014
Adana, , Turkey (Türkiye)
Zydus TR016
Altındağ, , Turkey (Türkiye)
Zydus TR004
Ankara, , Turkey (Türkiye)
Zydus TR005
Bursa, , Turkey (Türkiye)
Zydus TR017
Cebeli, , Turkey (Türkiye)
Zydus TR008
Gaziantep, , Turkey (Türkiye)
Zydus TR009
Istanbul, , Turkey (Türkiye)
Zydus TR010
Istanbul, , Turkey (Türkiye)
Zydus TR003
Istanbul, , Turkey (Türkiye)
Zydus TR001
Istanbul, , Turkey (Türkiye)
Zydus TR002
Izmir, , Turkey (Türkiye)
Zydus TR013
Izmir, , Turkey (Türkiye)
Zydus TR011
Kocaeli, , Turkey (Türkiye)
Zydus TR015
Melikgazi, , Turkey (Türkiye)
Zydus TR006
Mersin, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Ariadne Cabrera
Role: primary
Other Identifiers
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SARO.23.002
Identifier Type: -
Identifier Source: org_study_id
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