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Study for correlation between the time of hepatitis B vaccine inoculation and immune reconstitution in cured chronic HCV patients

Study for correlation between the time of hepatitis B vaccine inoculation and immune reconstitution in cured chronic HCV patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027418
Enrollment
Unknown
Registered
2019-11-12
Start date
2019-12-01
Completion date
Unknown
Last updated
2019-11-18

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

Conditions

Hepatitis C

Interventions

6-month injection group versus 12-month injection group:To inject hepatitis B vaccines

Sponsors

The Fifth Medical Center of Chinese PLA General Hospital (Beijing 302 Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) men/women, aged from 18 (inclusive) to 60 (inclusive); chronic hepatitis C patients who meet the diagnostic criteria of 2015 "guidelines for the prevention and treatment of hepatitis C"; 2) before being included in this study, they received DAA antiviral treatment, and the detection of HCV RNA (Cobas) was less than 15 IU / ml when they stopped antiviral treatment for 12 weeks; 3) no hepatitis B vaccine has been inoculated, or the serological markers of hepatitis B (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb) are all negative; 4) have the ability to understand and sign the informed consent and comply with the research requirements.

Exclusion criteria

Exclusion criteria: 1. received immunosuppressant and systemic cytotoxic drugs within 6 months before screening; 2. women who drank more than 20g (alcohol) per day or men who drank more than 40g per day in the previous year were screened for drug abuse history in the past year. The researchers believed that they could not comply with the treatment plan or influence the results of the study; 3. there was a transient history of liver decompensation caused by acute exacerbation of liver disease; 4. one of the following conditions occurs in laboratory inspection during screening: (1) serum creatinine 133umol/L; (2) prothrombin time was prolonged more than the upper limit of normal value for 4 seconds or PTA 5.0mg/dl (85umol / L); 5. simultaneously with HAV, HBV, HDV, HEV or HIV infection; 6. the subjects had a history of HCC or showed signs of HCC, such as suspicious lesions and / or AFP > 50ug / L. 7. history of liver function decompensation or clinical manifestations of decompensated liver disease; 8. in addition to hepatitis C, there are one or more other causes of liver disease (such as alcoholic liver disease, autoimmune liver disease, hemochromatosis, alpha antitrypsin deficiency, hepatolenticular degeneration, other congenital or metabolic diseases affecting the liver); 9. the subject has any other serious or active physical and mental diseases, which may affect the treatment, evaluation or compliance with the study plan in the opinion of the researcher. Including kidney, heart, lung, vascular, neurological, digestive (including history of pancreatitis), metabolic diseases (diabetes, thyroid and adrenal diseases), immune deficiency diseases or tumors; 10. pregnant or nursing women; 11. long term or prolonged use of drugs (including but not limited to dapsone, erythromycin, fluconazole, ketoconazole, rifampin, other antituberculosis agents) or nephrotoxic drugs (including but not limited to non steroidal anti-inflammatory drugs, aminoglycosides, amphotericin B, phosphonic acid) that may have hepatotoxicity is required.

Design outcomes

Primary

MeasureTime frame
HBsAb;

Countries

China

Contacts

Public ContactYongqian Cheng

The Fifth Medical Center of Chinese PLA General Hospital (Beijing 302 Hospital),Beijing, China

chengyq302@126.com+86 13911202563

Outcome results

None listed

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