Hepatitis B or Hepatitis B induced compensatory cirrhosis
Conditions
Interventions
A:NAs+IFN
B:NAs
Sponsors
Beijing Ditan Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Chinese patients aged 16-65 with CHB or hepatitis B induced compensatory cirrhosis; (2) Accepting antiviral treatment with NAs (whatever the types,programs or duration) and achieving HBV DNA <20IU/ml and HBsAg<1000IU/ml; (3) Child-Pugh score <7; (4) No contraindications for interferon therapy; (5) Participant or legal guardian agrees to participate in the study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) HBsAg or HBV DNA did not meet the inclusion criteria before screening; (2) Received IFN or other immunomodulatory treatment 52 weeks before screening,including(but not limited to any type of interferon,thymosin,IL-12 or other drugs that may have systemic immunomodulatory effects; (3) patients with hepatic decompensation(Child-Pugh >7)or once had the history of hepatic decompensation; (4) Diagnosed with liver cancer,being suspected of liver caner, or AFP>100ng/ml.If AFP is in the normal upper limit of 2 times to 100ng/ml and reexamination after 2 weeks shows AFP still >100ng/ml,patients can't be included; (5) Co-infection with hepatitis C virus, hepatitis D virus, HIV or combined with any other liver diseases; (6) Combined with severe heart, brain, kidney or other organ's diseases; (7) IFN should not be used in patients with pregnancy, uncontrolled hypertension, uncontrolled diabetes, uncontrolled thyroid diseases and diagnosed or suspected to have myositis,myopathy or peripheral neuropathy; (8) Intaking of ethanol more than 40 grams/day or abusing of illicit drugs in one year; (9) Requiring systemic using of acyclovir, panicilowei or other drugs regularly; (10) Requiring systemic using of corticosteroids regularly(allowing local use or inhalation); (11) Using liver toxicity drugs(lncluding but not limited to dapsone, erythromycin, fluconazole, ketoconazole, rifampin and other anti-TB preparationsor nephrotoxic drugs(including but not limited to non-steroidal anti-inflammatory drugs, aminoglycosides, amphotericin B, foscarnet)within one month and need continue to use for a long time; (12) Be allergic to interferon and polyethylene glycol; (13) Having any history of cancer over the past five years; (14) Non-compliant patient or any condition that may interfere the study; (15) Other conditions considered unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the level of HbsAg; | — |
Secondary
| Measure | Time frame |
|---|---|
| the level of HBV DNA; | — |
Countries
China
Contacts
Public ContactHuichun Xing
Beijing Ditan Hospital Capital Medical University
Outcome results
None listed