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Keratin 23 as a Pro-fibrotic Molecular Switch in HBV Cirrhosis

Molecular Mechanism Study of Keratin 23 in Promoting Chronic Hepatitis B-Related Liver Fibrosis/Cirrhosis by Regulating Hepatic Stellate Cells via the TGF-ß1/Smad2 Signaling Pathway

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600127223
Enrollment
Unknown
Registered
2026-06-26
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

liver fibrosis

Interventions

F3: Severe fibrosis:None
F1: Mild fibrosis:None
F4: Cirrhosis:None
F2: Significant fibrosis:None
Healthy control group:None

Sponsors

Shanghai Public Health Clinical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. According to the diagnostic criteria set by the National Health Commission, participants were selected from hospital physical examination centers, outpatient and inpatient CHB patients, liver cancer surgery patients, hemangioma surgery patients, and healthy individuals (all signed informed consent forms). 2. Before participating in the study, participants underwent tests including a ten-item immune panel, liver function, and HBV DNA testing to rule out co-infections with hepatitis A, C, D, and E viruses. Other liver diseases and immune system disorders such as fatty liver, alcoholic liver disease, autoimmune hepatitis, and drug-induced hepatitis were also excluded. Additionally, participants had not received any antiviral or immune-regulating treatments in the six months prior to enrollment. 3. Peripheral blood samples were collected from healthy individuals undergoing physical exams or from outpatient and inpatient CHB patients. 4. Healthy liver tissue was obtained from leftover samples from liver transplants or from normal liver tissue adjacent to surgically removed hemangiomas or metastatic liver tumors. Liver fibrosis samples were obtained from liver biopsy samples (mainly for immunohistochemical analysis) or from non-tumor tissue adjacent to liver cancer surgery specimens (HBsAg positive, with liver fibrosis).

Exclusion criteria

Exclusion criteria: 1. Patients under 18 or over 75 years old; 2. Co-infection with hepatitis A, C, D, or E virus; 3. Liver disease caused by other reasons, including but not limited to alcoholic liver disease, non-alcoholic fatty liver disease, autoimmune liver disease, drug-induced liver injury, genetic metabolic liver disease, etc.; 4. HIV infection or other diseases that cause immune deficiency; 5. Received any antiviral treatment (such as nucleos(t)ide analogs, interferon), immunomodulators, or anti-fibrosis therapy within 6 months before enrollment; 6. Presence of hepatocellular carcinoma or other malignant tumors confirmed by imaging or pathology; 7. Pregnant or breastfeeding women; 8. Severe dysfunction of key organs such as heart, lungs, or kidneys; 9. Any other conditions deemed inappropriate for participating in this study by the investigator.

Design outcomes

Primary

MeasureTime frame
Complications related to cirrhosis;Adverse Event/Serious Adverse Event;

Countries

China

Contacts

Public ContactCheng Tian

Shanghai Public Health Clinical Center

tiancheng@shaphc.org+86 21 3799 0333

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026