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

Last updated: March 16, 2019
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hepatitis

Hepatitis B

Treatment

N/A

Clinical Study ID

NCT02287857
CTTQ-TDF-V4.0
  • Ages 18-65
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The initial treatment of subjects diagnosed of HBeAg positive or negative chronichepatitis B

  • Aged 18 to 65 years old,male or female

  • Patients with previously HBsAg-positive lasted for 6months at least:HBeAg-positivesubjects, 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 ≤ 3seconds).

  • 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

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 andneuropsychiatric diseases.

  • Patients with metabolic or autoimmune diseases such as systemic lupus erythematosus.

  • Patients allergic for study drug.

Study Design

Total Participants: 360
Study Start date:
September 01, 2014
Estimated Completion Date:
October 31, 2019

Connect with a study center

  • Beijing Ditan Hospital Capital Medical University

    Beijing, Beijing 100015
    China

    Active - Recruiting

  • Beijing You An Hospital, Capital Medical University

    Beijing, Beijing 100069
    China

    Active - Recruiting

  • Peking University First Hospital

    Beijing, Beijing 100034
    China

    Active - Recruiting

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Active - Recruiting

  • First Affiliated Hospital, Third Military Medical University

    Chongqing, Chongqing 400039
    China

    Active - Recruiting

  • Third Affiliated Hospital of Sun Yat-sen

    Guangzhou, Guangdong 510630
    China

    Active - Recruiting

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Active - Recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Henan 450003
    China

    Active - Recruiting

  • First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu
    China

    Active - Recruiting

  • The Second Hospital of Nanjing

    Nanjing, Jiangsu 210003
    China

    Active - Recruiting

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai 200040
    China

    Active - Recruiting

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

  • Shanghai Public Health Clinical Center

    Shanghai, Shanghai 201508
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdou, Sichuan 610041
    China

    Active - Recruiting

  • First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang
    China

    Active - Recruiting

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