Efficacy and Safety of Domestic Tenofovir Tablets in Chinese Patients With Chronic Hepatitis B

March 16, 2019 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
The purpose of this study is to evaluate the safety and efficacy of Domestic Tenofovir Disoproxil Fumarate Tablets in Chinese patients with hepatitis B ,compared with Tenofovir Disoproxil Fumarate Tablets of Gilead.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
      • Beijing, Beijing, China, 100015
        • Recruiting
        • Beijing Ditan Hospital Capital Medical University
        • Contact:
      • Beijing, Beijing, China, 100069
        • Recruiting
        • Beijing You An Hospital, Capital Medical University
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China, 400039
        • Recruiting
        • First Affiliated Hospital, Third Military Medical University
        • Contact:
          • Yong chuan Chen, doctor
          • Phone Number: 13883405537
          • Email: zwmcyc@163.com
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • Third Affiliated Hospital of Sun Yat-sen
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:
          • Xiu Jin, doctor
          • Phone Number: 13526660319
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Juan Li, doctor
          • Phone Number: 13526506270
    • Jiangsu
      • Nanjing, Jiangsu, China, 210003
        • Recruiting
        • The Second Hospital of Nanjing
        • Contact:
          • Yu Pan, doctor
          • Phone Number: 13814099474
      • Nanjing, Jiangsu, China
        • Recruiting
        • First Affiliated Hospital of Nanjing Medical University
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital, Fudan University
        • Contact:
          • Fei Dong, doctor
          • Phone Number: 02152888041
      • Shanghai, Shanghai, China, 201508
        • Recruiting
        • Shanghai Public Health Clinical Center
        • Contact:
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital Shanghai Jiaotong University School of Medicine
        • Contact:
    • Sichuan
      • Chengdou, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • First Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:
          • Li hua Wu, doctor
          • Phone Number: 13819195192

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

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The initial treatment of subjects diagnosed of HBeAg positive or negative chronic hepatitis B
  • Aged 18 to 65 years old，male or female
  • Patients with previously HBsAg-positive lasted for 6months at least：HBeAg-positive subjects, HBV-DNA> 105copies/ml； HBeAg-negative subjects, HBV-DNA> 104copies/ml.
  • 2 times the upper normal limit (2 × ULN) ≤ alanine aminotransferase (ALT) ≤ 10 × ULN.
  • Total serum bilirubin (TBIL) ≤ 2.5 × ULN.
  • Prothrombin activity (PTA) ≥ 60% or prothrombin time prolonged than normal ≤ 3 seconds).
  • WBC ≥ 3.5 × 109 / L, PLT ≥ 80 × 109 / L, serum albumin (ALB)≥ 35 g / L.
  • Creatinine (Cr) ≤ 1× ULN，serum phosphate was normal.
  • Patients signed an informed consent form and compliance was good.

Exclusion Criteria:

  • Patients were infected with other viruses as HAV, HCV, HEV, HIV etc.
  • Patients with cirrhosis or liver cancer.
  • Pregnant woman, lactating women .
  • Patients with severe heart, kidney, endocrine hematopoietic system and neuropsychiatric diseases.
  • Patients with metabolic or autoimmune diseases such as systemic lupus erythematosus.
  • Patients allergic for study drug.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Domestic Tenofovir Disoproxil Fumarate Tablets
Drug: Domestic Tenofovir Disoproxil Fumarate Tablets
1 Domestic Tenofovir Disoproxil Fumarate Tablets and 1 blank Tenofovir Disoproxil Fumarate Tablets of Gilead
Active Comparator: Tenofovir Disoproxil Fumarate Tablets of Gilead
Drug: Tenofovir Disoproxil Fumarate Tablets of Gilead
1 blank Domestic Tenofovir Disoproxil Fumarate Tablets and 1Tenofovir Disoproxil Fumarate Tablets of Gilead

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compared with baseline, decline of serum HBV-DNA in the value
Time Frame: 48 week
48 week

Collaborators and Investigators

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

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Investigators

  • Principal Investigator: Yan yan Yu, doctor, Peking University First Hospital
  • Principal Investigator: Hao Wang, doctor, Peking University People's Hospital
  • Principal Investigator: Jun Chen, doctor, Beijing Ditan Hospital
  • Principal Investigator: Xin yue Chen, doctor, Beijing You An Hospital, Capital Medical University
  • Principal Investigator: Wen hong Zhang, doctor, Huashan Hospital
  • Principal Investigator: Qing Xie, doctor, Ruijin Hospital
  • Principal Investigator: Shan ming Wu, doctor, Shanghai Public Health Clinical Center
  • Principal Investigator: Hong Tang, doctor, West China Hospital
  • Principal Investigator: Qing Mao, doctor, First Affiliated Hospital, Third Military Medical University
  • Principal Investigator: Zhi liang Gao, doctor, Third Affiliated Hospital of Sun Yat-sen
  • Principal Investigator: Ji fang Shen, doctor, Zhejiang University
  • Principal Investigator: Jun Li, doctor, The First Affiliated Hospital with Nanjing Medical University
  • Principal Investigator: Wei Zhao, doctor, The Second Hospital of Nanjing Medical University
  • Principal Investigator: Jia Shang, doctor, Henan Provincial People's Hospital
  • Principal Investigator: Zu jiang Yu, doctor, The First Affiliated Hospital of Zhengzhou University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2014

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

October 30, 2014

First Submitted That Met QC Criteria

November 6, 2014

First Posted (Estimate)

November 11, 2014

Study Record Updates

Last Update Posted (Actual)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 16, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTTQ-TDF-V4.0

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.

Clinical Trials on Chronic Hepatitis B

Clinical Trials on Domestic Tenofovir Disoproxil Fumarate Tablets

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe