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'Cocktail Therapy' Improves Clinical Cure Rate and Safety of Chronic Hepatitis B

'Cocktail Therapy' Improves Clinical Cure Rate and Safety of Chronic Hepatitis B

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046743
Enrollment
Unknown
Registered
2021-05-28
Start date
2021-06-01
Completion date
Unknown
Last updated
2022-01-24

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

Conditions

Chronic Hepatitis B

Interventions

Treatment Group 1:'Cocktail therapy'
Treatment Group 2:Long-acting interferon + propofol tenofovir
Treatment Group 3:Propofol tenofovir

Sponsors

The Third People's Hospital of Shenzhen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. All patients signed an informed consent form; 2. HBsAg(+), the course of disease is more than half a year; 3. HBeAg(+) or HBeAg(-); 4. Aged 18-65 years; 5. ALT >= the upper limit of normal, or liver biopsy with G2 or S2 and above lesions, or aged> 30 years, with normal ALT, family history of liver cirrhosis/liver cancer, and positive HBV DNA; 6. Female subjects of childbearing age have a negative pregnancy test before the test and can take effective contraceptive measures; those who agree to contraception within six months after the end of treatment during the treatment period (including female partners of female and male patients).

Exclusion criteria

Exclusion criteria: 1. Those with a known history of allergies to interferons, nucleoside antivirals, and colony stimulating factors; 2. Those who are combined with other viral infections such as HAV, HCV, HDV, HEV, and HIV; 3. There is evidence of decompensated liver disease (Child-Pugh score>7), history or evidence of liver disease caused by other reasons (such as autoimmune liver disease, alcoholic liver disease, non-alcoholic fatty liver disease, drug-induced hepatitis, hepatolenticular degeneration, etc.); 4. Pregnant or lactating women; 5. There was a history of alcohol or drug abuse within one year before the trial was enrolled in the screening; 6. When the treatment group involves interferon screening: neutrophil count = 7 points; 9. Chronic diseases that require long-term treatment, such as hypertension, diabetes, chronic obstructive pulmonary disease, etc.; 10. Malignant tumor; 11. Through imaging examination, it is clearly diagnosed as a patient with liver cancer, or a patient with symptoms and signs of hepatocellular carcinoma, AFP > 400ng/ml; 12. Previous history of antiviral therapy; 13. Other diseases that the researcher thinks are not suitable for inclusion in the group.

Design outcomes

Primary

MeasureTime frame
HBsAg seroconversion rate;

Countries

China

Contacts

Public ContactLi Guojun

The Third People's Hospital of Shenzhen

ligj123@aliyun.com+86 13691944938

Outcome results

None listed

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