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

Primary Purpose

Chronic Hepatitis b

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Pradefovir Mesylate;Placebo of Tenofovir disoproxil fumarate tablet

Tenofovir disoproxil fumarate tablet;Placebo of Pradefovir Mesylate

About this trial

This is an interventional treatment trial for Chronic Hepatitis b

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The First Hospital of Jilin UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Trial group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

HBV viral suppression

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

Secondary Outcome Measures

HBV viral suppression

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

HBV viral suppression

proportion of patients with hepatitis B virus(HBV) -DNA undetectable(<20IU/ml)

The reduction of HBV DNA load

the change of HBV DNA load from baseline

ALT normalization

proportion of patients with ALT normalization

Full Information

NCT ID

NCT04543565

First Posted

September 2, 2020

Last Updated

September 8, 2020

Sponsor

Xi'an Xintong Pharmaceutical Research Co.,Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04543565

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Recruiting

Study Start Date

September 2020 (Anticipated)

Primary Completion Date

October 2022 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xi'an Xintong Pharmaceutical Research Co.,Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis b

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Trial group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Pradefovir Mesylate;Placebo of Tenofovir disoproxil fumarate tablet

Intervention Description

Once daily

Intervention Type

Drug

Intervention Name(s)

Tenofovir disoproxil fumarate tablet;Placebo of Pradefovir Mesylate

Intervention Description

Once daily

Primary Outcome Measure Information:

Title

HBV viral suppression

Description

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

Time Frame

After 48-week therapy

Secondary Outcome Measure Information:

Title

HBV viral suppression

Description

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

Time Frame

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

Title

HBV viral suppression

Description

proportion of patients with hepatitis B virus(HBV) -DNA undetectable(<20IU/ml)

Time Frame

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

Title

The reduction of HBV DNA load

Description

the change of HBV DNA load from baseline

Time Frame

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

Title

ALT normalization

Description

proportion of patients with ALT normalization

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

daidi Wang

Phone

+86 029 68790358

wangdd@xtyw.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Junqi Niu, Dr.

Organizational Affiliation

The First Hospital of Jilin University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First Hospital of Jilin University

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130061

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Junqi Niu, Dr.

Phone

13756661205

junqiniu@aliyun.com

12. IPD Sharing Statement

Learn more about this trial

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

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