Pradefovir Treatment for the Patients With Chronic Hepatitis B Virus Infections: a Phase3 Study

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase three study to evaluate the safety and efficacy of Pradefovir treatment in chronic hepatitis B patients. Subject will be randomized to Pradefovir group and TDF group at a ratio of 2:1. Treatment duration will be 96w in randomization and followed by 48w in open. The interim analysis will be conducted when all subject completed the first 48-week treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xi'an Xintong Pharmaceutical Research Co.,Ltd.
• Treatments: Pradefovir; Tenofovir

Criteria

Inclusion Criteria:

• Age from 18 to 65 years old, male or female.

• Meets the diagnosis and treatment standards of chronic hepatitis B( HBsAg or HBV DNA positive over 6 months, or diagnosed by liver biopsy.

• For HBeAg positive, HBV DNA equal or over 20000 IU/ml; for HBeAg negative ,HBV DNA equal or over 2000 IU/ml.

• ALT level between 1.2 ULN to 10 UNL.

• Treatment naive or experienced when any nucleos(t)ide analogs or interferons stopped over 6 months.

• Use of effective contraceptive measures if procreative potential exists.

• Written informed consent.

Exclusion Criteria:

• Allergic to study drug,metabolite product or excipient.

• Evidence of hepatic decompensation such as Child-Pugh B or C, with previous gastroesophageal variceal haemorrhage, hepatic encephalopathy, ascites

• Suspected or confirmed hepatocellular carcinoma, or AFP>50μg/L.

• Other liver diseases (such as Chronic alcoholic hepatitis, drug-induced hepatitis, autoimmune liver disease).

• Resistant to antiviral drugs (adefovir or tenofovir).

• Concommitant disease of severe heart, blood, respiratory and central nervous system diseases.

• Chronic kidney diseases, or Ccr<60ml/min at screening.

• Abnormal hematological and biochemical parameters at screening: White blood cell count less than 3.0×109/L，or neutrophil count less than 1.5×109/L，or platelet count less than 80×109/L，or total bilirubin more than 2ULN，or the prolong of PT more than 3s.

• Positive-HCV or positive-HIV.

• Severe bone disease (such as osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, rickets) or multiple fractures.

• History of pancreatitis or malignancy within 5 years (excluding cervical epithelial carcinoma, squamous epithelial carcinoma, or basal cell carcinoma of the skin that was clinically cured within 5 years of diagnosis).

• Plan to receive or have already had an organ transplant.

• Subject with disabilities as prescribed by law (blindness, deafness, deafness, deafness, mental disorders, etc.).

• History of alcohol or drug abuse within the last 1 year.

• Pregnant or lactating women.

• Participated in any clinical trial or taken any IMP (investigational medical product) within 3 months prior to the trial.

• Other cases that could not be enrolled in the judgement of the investigators.