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NCT06155760
Role of Extended Low Dose Prednisolone in Achieving Clinical and Biochemical Remission in Steroid Responsive Severe Alcoholic Hepatitis
NA trial testing Prednisolone in Severe Alcoholic Hepatitis in 150 participants. Status unknown.
27 February 2025
Quick facts
| Lead sponsor | Institute of Liver and Biliary Sciences, India |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 25 November 2023 |
| Primary completion | 27 February 2025 |
| Estimated completion | 27 February 2025 |
| Sites | 1 location across India |
Drugs / interventions tested
- Prednisolone — full drug profile →
- Standard Medical therapy — full drug profile →
- Placebo
Conditions studied
- Severe Alcoholic Hepatitis — all drugs for Severe Alcoholic Hepatitis →
Sponsor
Institute of Liver and Biliary Sciences, India
Who can join
Adults 18 to 60, any sex, with Severe Alcoholic Hepatitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Severity of alcoholic hepatitis is defined by Maddrey's discriminant function, value of 32 or higher indicates severe alcoholic hepatitis that carries an adverse prognosis with one month mortality of 30%-50%. Prednisolone (40 mg/day) given orally should be considered to improve 28-day mortality in patients with severe AH. Abstinence is key to long-term survival. According to current protocol, we discontinue the treatment after 28 days but only 15 % patient is achieving the DF \< 32 after 28 days of treatment. The aim of this study is to evaluate the role of extended low dose prednisolone (10mg) in achieving remission by day-90 in steroid responsive severe alcoholic hepatitis.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Current Clinical Trials for Alcohol-Associated Hepatitis.
Rady ED, Anouti A, Mitchell MC, Cotter TG. · · 2026 · cited 3× · PMID 40254132 · DOI 10.1016/j.ajpath.2025.03.009 -
Alcohol-Associated Hepatitis: Translating Pathophysiology into Targeted Clinical Trials.
Ma J, Gao H, Zeng G, Huda N, et al · · 2025 · PMID 41163775 · DOI 10.1007/s11901-025-00703-9
Verify or expand the search:
- PubMed search for NCT06155760
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06155760 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institute of Liver and Biliary Sciences, India
- Last refreshed: 4 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06155760.
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