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Trial record 114 of 350 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
Sponsor:
Information provided by (Responsible Party):
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier:
NCT02287857
First received: October 30, 2014
Last updated: November 6, 2014
Last verified: October 2014
  Purpose
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.

Condition Intervention
Chronic Hepatitis B
Drug: Domestic Tenofovir Disoproxil Fumarate Tablets
Drug: Tenofovir Disoproxil Fumarate Tablets of Gilead

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd:

Primary Outcome Measures:
  • Compared with baseline, decline of serum HBV-DNA in the value [ Time Frame: 1 month ]

Estimated Enrollment: 260
Study Start Date: September 2014
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02287857

Contacts
Contact: Yan yan Yu, doctor 13901194223 yyy@bjnu.edu

Locations
China, Beijing
Beijing Ditan Hospital Capital Medical University Recruiting
Beijing, Beijing, China, 100015
Contact: Xiao hua Hao, doctor    13466590802    xiaohualuck@sina.com   
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Li qin Yu, doctor    010-66119025    jgbgs090101@126.com   
Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100044
Contact: Hao Wang, doctor    010-88325988    jgbgs090101@126.com   
Beijing You An Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100069
Contact: Mei xia Wang, doctor    010-83997322    youangcp@163.com   
China, Chongqing
First Affiliated Hospital, Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400039
Contact: Yong chuan Chen, doctor    13883405537    zwmcyc@163.com   
China, Guangdong
Third Affiliated Hospital of Sun Yat-sen Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Qian Huang, doctor    02085253153    sankyk@163.com   
China, Henan
Henan Provincial People's Hospital Recruiting
Zhengzhou, Henan, China, 450003
Contact: Xiu Jin, doctor    13526660319      
First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Contact: Juan Li, doctor    13526506270      
China, Jiangsu
The Second Hospital of Nanjing Recruiting
Nanjing, Jiangsu, China, 210003
Contact: Yu Pan, doctor    13814099474      
First Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China
Contact: Xu Huang, doctor    02568136360    jsphkj@163.com   
China, Shanghai
Ruijin Hospital Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Yi feng Wang, doctor    02154661789    ruijin_gcp@126.com   
Huashan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200040
Contact: Fei Dong, doctor    02152888041      
Shanghai Public Health Clinical Center Recruiting
Shanghai, Shanghai, China, 201508
Contact: Na Li, doctor    18916082023    lina40125@shaphc.org   
China, Sichuan
West China Hospital of Sichuan University Recruiting
Chengdou, Sichuan, China, 610041
Contact: Juan Liao, doctor    15828323384    hxcrgcp@163.com   
China, Zhejiang
First Affiliated Hospital of Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China
Contact: Li hua Wu, doctor    13819195192      
Sponsors and Collaborators
Jiangsu Chia-tai Tianqing Pharmaceutical 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, Fudan University
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 First Affiliated Hospital of Zhejiang University School of Medicine
Principal Investigator: Jun Li, doctor The First Affiliated Hospital with Nanjing Medical University
Principal Investigator: Wei Zhao, doctor The Second Hospital of Nanjing
Principal Investigator: Jia Shang, doctor Henan Provincial Hospital
Principal Investigator: Zu jiang Yu, doctor The First Affiliated Hospital of Zhengzhou University
  More Information

Responsible Party: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier: NCT02287857     History of Changes
Other Study ID Numbers: CTTQ-TDF-V3.0
Study First Received: October 30, 2014
Last Updated: November 6, 2014

Additional relevant MeSH terms:
Hepatitis
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on March 24, 2017