Clinical trial of pirfenidone in mild to moderate alcoholic hepatitis patients to reduce the severity of the disease

Efficacy of Pirfenidone in Reducing Inflammation Among the Patients with Mild to Moderate Alcoholic Hepatitis: A Randomized Double-Blinded Placebo Controlled Trial - NILL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075647

Enrollment

144

Registered

2024-10-22

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K701- Alcoholic hepatitis

Interventions

Intervention1: Pirfenidone: Patients with mild to moderate alcoholic hepatitis will receive tablet pirfenidone 400 mg TDS along with standard of care. Control Intervention1: Placebo: Placebo will be g

Eligibility

Inclusion criteria

Inclusion criteria: 1. Alcoholic hepatitis patients of either gender aged 18–65 years with a present history of alcohol abuse as confirmed by CAGE questionnaire score greater than or equal to 2. 2. Patients with elevated liver enzymes levels, with AST/ALT ratio greater than 1.5

Exclusion criteria

Exclusion criteria: 1. Patients who are terminally ill (encephalopathy, spontaneous bacterial peritonitis, and hepatorenal syndrome) with severe alcoholic hepatitis (MDF greater than or equal to 32), AST levels greater than 500 IU/L 2. Patients with viral and drug-induced hepatitis. 3. Patients with comorbid conditions such as coronary artery disease and peripheral vascular disease. 4. Patient with uncontrolled diabetes, BMI greater than 30 and any inflammatory diseases. 5. Pregnant women or lactating mothers and women in reproductive age group not practicing contraceptive measures. 6. Patients who had participated in other trials in the past 3 months. 7. Patients on herbal medications.

Design outcomes

Primary

Measure	Time frame
To assess the efficacy of a four-week administration of pirfenidone on the level of inflammatory cytokines, TNFa and TGFß1 among the patients with mild to moderate alcoholic hepatitis.Timepoint: Baseline and 4 weeks for all outcomes except transient elastography which is assessed at baseline and 3 months later	—

Secondary

Measure	Time frame
1. To evaluate the efficacy of pirfenidone on improvement of liver function, renal function, lipid profile and hematological parameters among the patients with mild to moderate alcoholic hepatitis. 2. To assess the efficacy of pirfenidone in improving the shear wave elastography grading of liver fibrosis, APRI index and FIB-4 index. 3. To assess the safety and adverse reactions associated with pirfenidone treatment.Timepoint: 1. Secondary outcome 1 is done at baseline and after 4 weeks of treatment initiation. 2. Outcome 2 is measured at baseline and after 3 months from treatment initiation 3. Outcome 3 is measured at baseline, every week by telephone, at 4 weeks and after 3 months visit.	—

Measure

Time frame

1. To evaluate the efficacy of pirfenidone on improvement of liver function, renal function, lipid profile and hematological parameters among the patients with mild to moderate alcoholic hepatitis. 2. To assess the efficacy of pirfenidone in improving the shear wave elastography grading of liver fibrosis, APRI index and FIB-4 index. 3. To assess the safety and adverse reactions associated with pirfenidone treatment.Timepoint: 1. Secondary outcome 1 is done at baseline and after 4 weeks of treatment initiation. 2. Outcome 2 is measured at baseline and after 3 months from treatment initiation 3. Outcome 3 is measured at baseline, every week by telephone, at 4 weeks and after 3 months visit.

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Countries

India

Contacts

Public ContactWilfred Ashwin K

JIPMER, Puducherry

gcnx2005@gmail.com9442200298

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026