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A single center, prospective, randomized controlled cohort study to explore the efficacy and safety of early and sufficient simplified N-acetylcysteine combined with Lee's artificial liver in the treatment of hepatitis B liver failure

A single center, prospective, randomized controlled cohort study to explore the efficacy and safety of early and sufficient simplified N-acetylcysteine combined with Lee's artificial liver in the treatment of hepatitis B liver failure

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123231
Enrollment
Unknown
Registered
2026-04-23
Start date
2022-01-28
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Liver failure

Interventions

Standard Treatment Group:Li's artificial liver support combined with N-acetylcysteine (NAC) standard dosing regimen (loading dose: D1 8g infused over 1h
2g infused over 4h
6g infused over 16h
D2 4g q12h
D3 4g q12h)
Simplified Regimen Group:Li's artificial liver support combined with N-acetylcysteine (NAC) simplified dosing regimen (D1 4g q6h (>2h)
D2 4g q12h (>2h)

Sponsors

Shulan (Hangzhou) hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age greater than or equal to 18 years old and less than 70 years old 2. INR>1.5 3. TB>10 times ULN 4. Hepatitis B surface antigen or hepatitis B DNA positive 5. The subject (or guardian) has signed the informed consent form

Exclusion criteria

Exclusion criteria: 1. Liver failure caused by non hepatitis B virus 2. Pregnant women or women planning to conceive 3. Post transplant patients 4. Merge tumor patients 5. Combining patients with immune disorders and long-term use of immunosuppressants and/or glucocorticoids 6. Patients with significant impact on prognosis due to the combination of other serious chronic diseases 7. Merge patients with other chronic organ dysfunction disorders 8. Merge active bleeding patients 9. Acetylcysteine allergy or intolerance 10. Other researchers believe that those who cannot complete clinical trials

Design outcomes

Primary

MeasureTime frame
Survival rate (4 and 12 weeks);

Secondary

MeasureTime frame
Adverse reactions related to acetylcysteine;The changes in MELD score and COSSH score;Laboratory indicators: Blood biochemical tests show changes in TBil, PTA (INR), etc;Survival rates at 24 and 48 weeks;

Countries

China

Contacts

Public ContactGao Hai

Shulan (Hangzhou) hospital

hainv.gao@shulan.com+86 139 5716 3067

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026