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

NCT04543565 | Unknown Phase 3

• 1 other identifier: BOJI201939F
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Hepatitis b

Outcome Measures

Primary Outcomes (1)

• HBV viral suppression

  proportion of patients with hepatitis B virus(HBV) -DNA undetectable(\<29IU/ml)

  After 48-week therapy

Secondary Outcomes (4)

• HBV viral suppression

  After therapy of 4, 8, 12, 24, 36, 72, 96, 144 weeks

• HBV viral suppression

  After therapy of 4, 8, 12, 24, 48, 36, 72, 96, 144 weeks

• The reduction of HBV DNA load

  at week 4, 8, 12, 24, 36, 48, 72, 96, 144

• ALT normalization

  After therapy of 4, 8, 12, 24, 48, 36, 72, 96, 144 weeks

Study Arms (2)

Trial group

EXPERIMENTAL

subject in this group will receive Pradefovir mesylate tablet and the placebo of tenofovir disoproxil fumarate tablet, once daily for 96 weeks

Drug: Pradefovir Mesylate;Placebo of Tenofovir disoproxil fumarate tablet

Control group

ACTIVE COMPARATOR

subject in this group will receive tenofovir disoproxil fumarate tablet and the placebo of Pradefovir mesylate tablet, once daily for 96 weeks.

Drug: Tenofovir disoproxil fumarate tablet;Placebo of Pradefovir Mesylate

Interventions

Pradefovir Mesylate;Placebo of Tenofovir disoproxil fumarate tablet DRUG

Once daily

Trial group

Tenofovir disoproxil fumarate tablet;Placebo of Pradefovir Mesylate DRUG

Once daily

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xi'an Xintong Pharmaceutical Research Co.,Ltd.: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130061, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Junqi Niu, Dr.

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

daidi Wang

CONTACT

+86 029 68790358; wangdd@xtyw.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 10, 2020
• Study Start: September 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2024
• Last Updated: September 10, 2020

Record last verified: 2020-09

Locations

CN (1)