A study to evaluate the safety and effectiveness of Saroglitazar 4 mg in patients with NAFLD with comorbidities
Phase 4
Recruiting
- Conditions
- Fatty (change of) liver, not elsewhere classified,
- Registration Number
- CTRI/2023/05/053326
- Lead Sponsor
- Zydus Lifesciences Limited (formerly Cadila Healthcare Limited)
- Brief Summary
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|This study is a phase 4, non-randomised, multicentre, open-label study. The study will be conducted at multiple study centres across India. The study is planned to enroll approximately 1500 patients. This is Open-label Treatment Phase (364days/52 weeks) study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 1500
Inclusion Criteria
- 1.Male and female patients aged ≥18 years 2.Patients who have been prescribed Saroglitazar for NAFLD will be included in this Phase 4 study (patients who use Saroglitazar for the first time) 3.Patients able to and willing to provide written informed consent and comply with the requirements of the study protocol 4.Patients with a prior documented diagnosis of NAFLD based on the AASLD criteria (Refer Appendix III for diagnostic criteria).
- NAFLD is defined either by previous histology or clinical imaging in individuals who consume little or no alcohol and do not have a cause for secondary hepatic steatosis or another cause of chronic liver disease.
- In addition, patients must have one of the following criteria to indicate ongoing NAFLD at screening: a.Liver stiffness through transient elastography, an LSM ≥8 kPa OR b.Serum ALT ≥45 U/L.
Exclusion Criteria
- 1.Consumption of alcohol for at least 90 consecutive days in last one year: >2 units of alcohol per day (>14 units per week) for males and >1 unit of alcohol per day (>7 units per week) for females.
- 2.History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and haemochromatosis.
- 3.Patient has known documented cirrhosis, either based on clinical criteria or liver histology or imaging.
- 4.Contraindications to Saroglitazar or any disease conditions affecting the ability to evaluate the effects of Saroglitazar.
- 5.History or other evidences of severe illness or any other conditions that would make patient, in the opinion of the investigator, unsuitable for the study.
- 6.Any previous history of ascites, hepatic encephalopathy, oesophageal varices or admission/emergency department visit for hepatic decompensation.
- Women of child bearing potential: inability or unwillingness to practice contraception for the duration of the study.
- Pregnant or breast feeding females.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in liver stiffness measurement performed by transient elastography and Frequency and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) Baseline to Week 52
- Secondary Outcome Measures
Name Time Method Change in serum ALT value Baseline to Week 24 and Week 52 Change in serum AST Baseline to Week 24 and Week 52 Change in serum ALP value Baseline to Week 24 and Week 52 Change in TG, HDL-C, LDL-C and non HDL-C levels Baseline to Week 24 and Week 52 Change in body weight and BMI Baseline to Week 24 and Week 52 To evaluate the safety of Saroglitazar 4 mg once daily in the study population Baseline to Week 52
Trial Locations
- Locations (37)
Osmania General Hospital
🇮🇳Hyderabad, TELANGANA, India
"Government General Hospital, GMC/GGH, Guntur"
🇮🇳Guntur, ANDHRA PRADESH, India
AIIMS
🇮🇳Khordha, ORISSA, India
Alchemist Hospital
🇮🇳Panchkula, HARYANA, India
Alfa Gastro and Liver Care
🇮🇳Ahmadabad, GUJARAT, India
Amrita Institute of Medical Sciences and Research Centre
🇮🇳Ernakulam, KERALA, India
Artemis Hospital
🇮🇳Gurgaon, HARYANA, India
BAPS Pramukh Swami Hospital
🇮🇳Surat, GUJARAT, India
BGS Gleneagles Global Hospital
🇮🇳Bangalore, KARNATAKA, India
BLK Hospital
🇮🇳Delhi, DELHI, India
Scroll for more (27 remaining)Osmania General Hospital🇮🇳Hyderabad, TELANGANA, IndiaDr B Ramesh KumarPrincipal investigator9949043290bhashyakarla_rk@gmail.com