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

NCT02287857 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2019-03-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Domestic Tenofovir Disoproxil Fumarate Tablets

1 Domestic Tenofovir Disoproxil Fumarate Tablets and 1 blank 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

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yan yan Yu, doctor · Peking University First Hospital

  • Hao Wang, doctor · Peking University People's Hospital

  • Jun Chen, doctor · Beijing Ditan Hospital

  • Xin yue Chen, doctor · Beijing You An Hospital, Capital Medical University

  • Wen hong Zhang, doctor · Huashan Hospital

  • Qing Xie, doctor · Ruijin Hospital

  • Shan ming Wu, doctor · Shanghai Public Health Clinical Center

  • Hong Tang, doctor · West China Hospital

  • Qing Mao, doctor · First Affiliated Hospital, Third Military Medical University

  • Zhi liang Gao, doctor · Third Affiliated Hospital of Sun Yat-sen

  • Ji fang Shen, doctor · Zhejiang University

  • Jun Li, doctor · The First Affiliated Hospital with Nanjing Medical University

  • Wei Zhao, doctor · The Second Hospital of Nanjing Medical University

  • Jia Shang, doctor · Henan Provincial People's Hospital

  • Zu jiang Yu, doctor · The First Affiliated Hospital of Zhengzhou University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2019-10-31
Completion
2019-10-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02287857 on ClinicalTrials.gov