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

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06427395Tipo: INTERVENTIONALInicio: 16 de jul de 2024Fin estimado: 18 de jul de 2027

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Resumen

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

Descripción detallada

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

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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 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)
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
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

Intervenciones

drug

Saroglitazar Magnesium 1 mg

Saroglitazar Magnesium 1 mg will be assigned to all participants enrolled in the open label extension program

Ubicaciones

Zydus AR001

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Mariela Gomez · mgomez@hospitalaleman.com

RECRUITING

Zydus AR007

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Ignacio Lucero · ignaciojlucero99@gmail.com

RECRUITING

Zydus AR006

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Karina Barroso · karibarroso@yahoo.com.ar

RECRUITING

Zydus AR005

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Verónica Martinez · veronicamartinez@gedyt.com.ar

RECRUITING

Zydus AR003

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Belen Umina · umina.belen@centromedicosaavedra.com.ar

RECRUITING

Zydus AR004

Pilar, Buenos Aires, Argentina

Gabriela Marinsalta · marinsa@austral.edu.ar

RECRUITING

Patrocinadores

PrincipalZydus Therapeutics Inc.

Contactos

Farheen Shaikh

CONTACT

fshaikh@zydustherapeutics.com 609-730-1900

Deven Parmar

CONTACT

dparmar@zydustherapeutics.com 609-559-0765

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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