A Prospective, Randomized, Multicenter, Open-label Study of Optimal Antiviral Treatment in HBeAg Positive Chronic Hepatitis B Patients
Overview
- Phase
- Phase 4
- Intervention
- Group A, TDF
- Conditions
- Chronic Hepatitis
- Sponsor
- Ruijin Hospital
- Enrollment
- 180
- Locations
- 8
- Primary Endpoint
- Number of subjects who achieve HBeAg seroconversion
- Last Updated
- 4 years ago
Overview
Brief 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.
Detailed Description
The HBeAg positive chronic hepatitis B(CHB) subjects who has achieved HBV DNA\<10\*5copies/ml，HBsAg≤5000IU/ml, ALT≥ 2ULN or Liver histology G2S2 will be randomized to three groups. The subjects who go into group A will be treated by tenofovir disoproxil fumarate (TDF) for 96 weeks; The subjects who go into group B will be treated by TDF in the first 48 weeks, then will be treated by the combination of TDF and Peginterferon alfa-2a for another 48 weeks; The subjects who go into group C will be treated by the combination of TDF and Peginterferon alfa-2a for the first 48 weeks, then will be treated by TDF for another 48 weeks.
Investigators
Xinxin Zhang
vice president of Ruijin hospital(North collegue)
Ruijin Hospital
Eligibility Criteria
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;
- •ANC(absolute neutrophil count)\<1.5x 10\^9/L or PLT(platelet count)\<90x 10\^9/L
- •Creatinine over upper limit of normal;
Arms & Interventions
Group A,TDF
The subjects in group A will be treated by TDF for 96 weeks
Intervention: Group A, TDF
Outcomes
Primary Outcomes
Number of subjects who achieve HBeAg seroconversion
Time Frame: at 96 week
The number of subjects with HBeAg seroconversion at week 96 will be measured
Secondary Outcomes
- Number of participants who achieve HBeAg seroconversion(at 48 week;at 72 week)
- The percentage decrease of HBsAg level at group A,B,C(at 48 week;at 72 week;at 96 week)
- Number of participants who achieve HBeAg loss(at 48 week;at 72 week;at 96 week)
- The number of subjects who achieve HBVDNA undetectable(at 24 week;48 week;at 72 week;at 96 week)
- The factor such as HBsAg level related to responsible rate(at week 48,72,96)
- The number of subjects who achieve ALT back to normal(at 48 week;at 72 week;at 96 week)