UnknownPhase 4

Study on an Optimal Antiviral Treatment in HBeAg Positive Chronic Hepatitis B Patients

China180 participantsStarted 2016-11

Plain-language summary

The current study is a prospective, randomized, open, multi-center investigation. The aim of the study is to investigate whether the HBeAg seroconversion rate can be improved if applying combination therapy in HBeAg positive CHB patients who has achieved HBVDNA\<105copies/ml，HBsAg≤5000IU/ml, ALT≥ 2ULN or Liver histology G2S2.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Male and female patients with age ≥18 and ≤65 years;
✓. There should be evidences that HBsAg and HBeAg have been positive for more than 6 months with HBsAb and HBeAb negative;HBsAg≤50000IU/ml, ALT≥ 2ULN,Liver histology above G2S2 and HBV DNA≥10\*5 copies/mL;
✓. Women without ongoing pregnancy or breast feeding and both women and men willing to take an effective contraceptive measure during the treatment;
✓. Agree to participate in the study and sign the patient informed consent form.

Exclusion criteria

✕. Treated by immunosuppressant,immunomodulator,Systemic cytotoxic drug,herbs or HBIg within 6 months prior to the first dose of treatment;
✕. ALT≥10 X ULN or total bilirubin ≥2 X ULN;
✕. Allergic history to interferon;
✕. Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV);
✕. Child-Pugh scores \>7;
✕. History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassemia);
✕. Pregnant or breast-feeding Women;
✕. Consuming alcohol in excess of 20g/day for women and 30g/day for men within 6 months prior to enrollment or drug taking history;

What they're measuring

Number of subjects who achieve HBeAg seroconversion

Timeframe: at 96 week

Trial details

NCT IDNCT03013556

SponsorRuijin Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-30

Contact for this trial

Xinxin Zhang

zhangx@shsmu.edu.cn

View on ClinicalTrials.gov More Chronic Hepatitis trials