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NCT03069300: NACAH
N-ACetylcysteine to Reduce Infection and Mortality for Alcoholic Hepatitis
Phase 3 trial testing N-acetyl cysteine (NAC) in Alcoholic Hepatitis in 42 participants. Status unknown.
1 April 2022
Quick facts
| Lead sponsor | Imperial College London |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 1 October 2015 |
| Primary completion | 1 April 2022 |
| Estimated completion | 1 June 2025 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- N-acetyl cysteine (NAC) — full drug profile →
Conditions studied
- Alcoholic Hepatitis — all drugs for Alcoholic Hepatitis →
- Infection — all drugs for Infection →
Sponsor
Imperial College London
Who can join
18 and older, any sex, with Alcoholic Hepatitis or Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Recent data have suggested that monocyte oxidative burst defect is associated with the development of infection in patients with severe alcoholic hepatitis. One report found reduced 28 day mortality in patients treated with N-acetylcysteine combined with prednisolone when compared to prednisolone alone. The current study seeks to reveal whether the mechanism by which NAC reduces susceptibility to infection is through improvement of phagocyte oxidative burst.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Autophagy, Oxidative Stress, and Alcoholic Liver Disease: A Systematic Review and Potential Clinical Applications.
Salete-Granado D, Carbonell C, Puertas-Miranda D, Vega-Rodríguez VJ, et al · · 2023 · cited 38× · PMID 37507963 · DOI 10.3390/antiox12071425 -
Epidemiological Realities of Alcoholic Liver Disease: Global Burden, Research Trends, and Therapeutic Promise.
Xiao J, Wang F, Wong NK, Lv Y, et al · · 2020 · cited 28× · PMID 32690129 · DOI 10.3727/105221620x15952664091823 -
A Perspective Of Intestinal Immune-Microbiome Interactions In Alcohol-Associated Liver Disease.
Bruellman R, Llorente C. · · 2021 · cited 26× · PMID 33390852 · DOI 10.7150/ijbs.53589 -
Interleukin-22 in alcoholic hepatitis and beyond.
Xiang X, Hwang S, Feng D, Shah VH, et al · · 2020 · cited 25× · PMID 32892258 · DOI 10.1007/s12072-020-10082-6 -
Alcohol-associated liver disease: Natural history, management and novel targeted therapies.
Alvarado-Tapias E, Pose E, Gratacós-Ginès J, Clemente-Sánchez A, et al · · 2025 · cited 21× · PMID 39481875 · DOI 10.3350/cmh.2024.0709 -
Emerging medical therapies for severe alcoholic hepatitis.
Tornai D, Szabo G. · · 2020 · cited 19× · PMID 32981291 · DOI 10.3350/cmh.2020.0145 -
Alcohol-related hepatitis: A review article.
Chaudhry H, Sohal A, Iqbal H, Roytman M. · · 2023 · cited 12× · PMID 37213401 · DOI 10.3748/wjg.v29.i17.2551 -
Current Management and Future Treatment of Alcoholic Hepatitis.
Mitchell MC, Kerr T, Herlong HF. · · 2020 · cited 12× · PMID 34035720
Verify or expand the search:
- PubMed search for NCT03069300
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of N-acetyl cysteine (NAC)
Trials testing the same drug.
- NCT03730064 — Brain Imaging to Understand the Role of Inflammation in N-Acetyl Cysteine (NAC) Treatment of Bipolar Depression · EARLY_PHASE1 · completed
Other recruiting trials for Alcoholic Hepatitis
Currently open trials in the same condition.
- NCT06919458 — Short Course Steroids in Alcohol Associated Hepatitis · Phase 3 · recruiting
- NCT06307964 — Intra-Hepatic Microbiota in Alcoholic Hepatitis · recruiting
- NCT05006430 — Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis · Phase 1, PHASE2 · recruiting
- NCT05018481 — HA35 Moderate Alcoholic Hepatitis (AH) Study · EARLY_PHASE1 · recruiting
- NCT02473341 — Gut-Liver Axis Modulation With IgG-Enriched Immunotherapy in Severe Alcohol-Associated Hepatitis · Phase 3 · active not recruiting
Other Imperial College London trials
Trials by the same sponsor.
- NCT06035861 — Endothelial Cell Activation and Total Pulmonary Resistance in PAH · NA · not yet recruiting
- NCT07397455 — Development of a Controlled Human Infection Model for Assessment of SARS-CoV-2 Omicron Subvariants · Phase 1 · not yet recruiting
- NCT07422532 — A Multi-centre Trial to Assess the Efficacy and Safety of the Omnipod 5 System in People With Type 2 Diabetes Undergoing · NA · not yet recruiting
- NCT07389031 — Maralixibat for Intrahepatic Cholestasis of Pregnancy · Phase 2 · not yet recruiting
- NCT07358897 — Gender Affirming Hormone Therapy and Immune Function in Trans Individuals - The GIFT Study · not yet recruiting
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 NCT03069300 (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 Imperial College London
- Last refreshed: 9 November 2021
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/NCT03069300.
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