DImethylfumarate for CirrhOsis and Acute-on-Chronic Liver Failure

DImethylfumarate as a PyroptoSis inhibitor for CirrhOsis and Acute-on-Chronic Liver Failure - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/089239

Enrollment

Registered

2025-06-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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

Conditions

Health Condition 1: K721- Chronic hepatic failure

Interventions

Intervention1: Dimethylfumarate (DMF) plus standard of care: DMF 120mg bd will be used for 7 days, following which dose-escalation to 240mg bd will be instigated if safety criteria are met. If safety

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged more than 18 years with decompensated cirrhosis-CLIF-AD score more than equal to 45 or ACLF grade 1 or 2

Exclusion criteria

Exclusion criteria: 1.Hemodynamic instability (mean arterial pressure less than 60mHg or use of vasopressors to support blood pressure) 2.Uncontrolled bleeding 3.Concurrent use of corticosteroids 4. Lymphopenia (Absolute lymphocyte count less than 0.5x10^9/L 5.Active herpes zoster infection 6. Untreated alcohol dependence 7. Presentation to hospital with acute alcohol or drug intoxication 8.Pregnancy or breast feeding 9. Hypersensitivity to study drug or constituents 10. Inability to give informed consent

Design outcomes

Primary

Measure	Time frame
Primary outcomes: 1. Safety and tolerability of Dimethylfumarate (DMF) in cirrhosis [treatment-emergent AEs (TEAEs) or SAEs] compared to standard medical therapy (SMT) - proportion of patients experiencing TEAEs or SAEs, or progressing to grade 2/3 ACLF in both groups. 2. Efficacy of DMF in addition to SMT in patients with AD of cirrhosis (CLIF-AD score more than 45) or grade 1 ACLF (EASL -CLIF criteria) in reducing progression to grade 2 or grade 3 ACLF at day 28 compared to SMT.Timepoint: 28 days	—

Measure

Time frame

Primary outcomes: 1. Safety and tolerability of Dimethylfumarate (DMF) in cirrhosis [treatment-emergent AEs (TEAEs) or SAEs] compared to standard medical therapy (SMT) - proportion of patients experiencing TEAEs or SAEs, or progressing to grade 2/3 ACLF in both groups. 2. Efficacy of DMF in addition to SMT in patients with AD of cirrhosis (CLIF-AD score more than 45) or grade 1 ACLF (EASL -CLIF criteria) in reducing progression to grade 2 or grade 3 ACLF at day 28 compared to SMT.Timepoint: 28 days

—

Secondary

Measure	Time frame
Secondary Objectives: Markers of systemic inflammation and organ failure at 28 days - C-reactive protein, White cell count, Lactate dehydrogenase Change in CLIF-C organ failure (OF) score, CLIF-AD score, MELD score, AARC score, Child-Turcotte-Pugh score at 28-days Requirement for inpatient stay, intensive care unit (ICU) stay and/or organ support Timepoint: 28 days	—

Countries

India

Contacts

Public ContactShalimar

All India Institute of Medical Sciences, New Delhi

drshalimar@yahoo.com9968405815

Outcome results

None listed

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