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

September 8, 2020 updated by: Xi'an Xintong Pharmaceutical Research Co.,Ltd.

Pradefovir Treatment for the Patients With Chronic Hepatitis B Virus Infections: a Multi-center, Double-Blind, Randomized, Positive Control, Phase3 Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

this is a randomized, double-blind, positive drug parallel control, multicenter, phase 3 study .Eligible HBeAg-positive or HBeAg-negative chronic hepatitis B patients will be stratified by historical antiviral treatment (untreated or treated) at the time of screening, and then randomly assigned to Pradefovir mesylate tablet group or tenofovir disoproxil fumarate tablet group at a ratio of 2:1. The proportion of subject with compensatory stage of cirrhosis is no more than 20 percentage. Patients will receive a total of 144 weeks of antiviral treatments, and after 96 weeks of double-blind treatment, all subjects will switch to open mesylate Pradefovir tablets for additional 48 weeks. The first 48 weeks are the core period and the followed 96 weeks are the extension period. Statistical analysis was conducted on the efficacy and safety of the whole trial. (After the completion of 48-week visit of the last one subject, the interim analysis will be conducted. The analysts will be unblinded, while the remaining participants will still be blind.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
900

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130061
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Trial group
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
Once daily
Active Comparator: Control group
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
Once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HBV viral suppression
Time Frame: After 48-week therapy
proportion of patients with hepatitis B virus(HBV) -DNA undetectable(<29IU/ml)
After 48-week therapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HBV viral suppression
Time Frame: After therapy of 4, 8, 12, 24, 36, 72, 96, 144 weeks
proportion of patients with hepatitis B virus(HBV) -DNA undetectable(<29IU/ml)
After therapy of 4, 8, 12, 24, 36, 72, 96, 144 weeks
HBV viral suppression
Time Frame: After therapy of 4, 8, 12, 24, 48, 36, 72, 96, 144 weeks
proportion of patients with hepatitis B virus(HBV) -DNA undetectable(<20IU/ml)
After therapy of 4, 8, 12, 24, 48, 36, 72, 96, 144 weeks
The reduction of HBV DNA load
Time Frame: at week 4, 8, 12, 24, 36, 48, 72, 96, 144
the change of HBV DNA load from baseline
at week 4, 8, 12, 24, 36, 48, 72, 96, 144
ALT normalization
Time Frame: After therapy of 4, 8, 12, 24, 48, 36, 72, 96, 144 weeks
proportion of patients with ALT normalization
After therapy of 4, 8, 12, 24, 48, 36, 72, 96, 144 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xi'an Xintong Pharmaceutical Research Co.,Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Junqi Niu, Dr., The First Hospital of Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BOJI201939F

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings