A Multicenter, Open-Label, Extension Clinical trial to evaluate Safety and Efficacy of Saroglitazar Magnesium in Participants with Primary Biliary Cholangitis (PBC)
R
Raj Vuppalanchi, MD
Primary Investigator
Enrolling By Invitation
18 years - 100 years
All
Phase
N/A
10 participants needed
1 Location
Brief description of study
What is the purpose of this study?
This clinical trial (a medical research study) is an open-label extension of a previous research study, SARO.21.001, which evaluates the efficacy (improvement in liver enzymes and lipid profiles) and safety (side effects) of Saroglitazar Magnesium in participants with a medical condition known as Primary Biliary Cholangitis (PBC).
THIS STUDY IS ENROLLING BY INVITATION ONLY - This research study will enroll participants who were already enrolled and completed the SARO.21.001 study
Detailed description of study
What will happen during the study?
- At the completion of the SARO.21.001 safety follow-up visit, all eligible participants including those who received placebo will be offered the opportunity to receive Saroglitazar Magnesium (1 mg) for another 2 years and enter the optional open-label extension (OLE) study.
- The study will include a screening phase of approximately up to 2 weeks.
- There will be 9 out-patient visits to the study center, conducted at Months 0 (baseline), 3, 6, 9, 12, 15, 18, 21, and 24.
- All enrolled participants in this study will be invited to participate in the voluntary liver biopsy, which is an invasive medical procedure. The participants may have to undergo a liver biopsy procedure before the initiation of treatment phase (if not done within 6 months of enrolment), and at the end of treatment (EOT) in this study.
- The abdominal ultrasound and Liver elastography/Fibroscan® conducted at the EOT visit of previous clinical study SARO.21.001, may not be repeated in the screening phase of this study, provided screening is done no later than 4 weeks from the EOT visit.
- Prior to their study visit, participants will need to fast (no food or drink, except water) to ensure that approximately 8 hours of fasting is achieved before the scheduled blood sample collection.
- Participants who qualify to take part in this study will be issued a bottle of study drug tablets (Saroglitazar Magnesium 1 mg) and will be instructed to take one tablet daily before breakfast without food for the entire treatment duration.
- On study visit days, instead of taking the study drug at home, participants will be asked to take it at the study site after fasting blood sample collection.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Primary Biliary Cholangitis, PBC
-
Age: 18 years - 100 years
-
Gender: All
Inclusion Criteria:
- Must provide written informed consent and agree to comply with the trial protocol
- Participated and completed SARO.21.001, the double-blind treatment phase study
Exclusion Criteria:
- 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.
- Participants with MELD 3.0 score of 15 or greater
- History or presence of other concomitant liver diseases at screening:
- Chronic hepatitis B or C virus (HBV, HCV) infection
- Primary sclerosing cholangitis (PSC)
- Alcoholic liver disease
- Autoimmune hepatitis (AIH)-PBC overlap syndrome
- Hemochromatosis
- Non-alcoholic steatohepatitis (NASH) on historical biopsy
- 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.
- Use of Thiazolidinediones or Fibrates (within 12 weeks prior to screening)
- Use of 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)
- 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
- Unstable cardiovascular disease, including:
- 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
- History/current unstable cardiac dysrhythmias
- Uncontrolled hypertension at screening
- Stroke or transient ischemic attack in the 24 weeks before screening
- History of intracranial hemorrhage, arteriovenous malformation, bleeding disorder, and coagulation disorders
- An uncontrolled thyroid disorder
- 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
- Uncontrolled hypothyroidism: defined as initiation of thyroid hormone replacement therapy or dose adjustment of replacement therapy in the 12 weeks before screening
- History of myopathies or evidence of active muscle disease demonstrated by CPK ≥ 5 × ULN at screening
- Any of the following laboratory values:
- Total bilirubin > 3 x ULN
- Platelets < 50 × 103/mL
- Albumin < 2.8 g/dL
- eGFR < 45 mL/min/1.73 m2
- ALT or AST > 250 U/L x ULN
- ALP > 10 × ULN
- 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
- 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)
- Known allergy, sensitivity or intolerance to the study medication or formulation ingredients
- Pregnancy-related exclusions, including:
- Pregnant/lactating female (including positive pregnancy test at screening)
- 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.
- 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)
- Cirrhosis with Child-Pugh-Turcotte (CPT) class B or C having score of 7 or above at screening (Refer Appendix 11
Updated on
21 Apr 2025.
Study ID: GI-ZYDUS-SARO-23-002, 22916
Please visit our main page to search for other studies you may be interested in.
If you need help finding a study or have any questions, please contact us at inhealth@iu.edu