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

NCT02287857 | Unknown DMC

• 1 other identifier: CTTQ-TDF-V4.0
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 15

Brief 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

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Compared with baseline, decline of serum HBV-DNA in the value

  48 week

Study Arms (2)

Domestic Tenofovir Disoproxil Fumarate Tablets

EXPERIMENTAL

Drug: Domestic Tenofovir Disoproxil Fumarate Tablets

Tenofovir Disoproxil Fumarate Tablets of Gilead

ACTIVE COMPARATOR

Drug: Tenofovir Disoproxil Fumarate Tablets of Gilead

Interventions

Domestic Tenofovir Disoproxil Fumarate Tablets DRUG

1 Domestic Tenofovir Disoproxil Fumarate Tablets and 1 blank Tenofovir Disoproxil Fumarate Tablets of Gilead

Domestic Tenofovir Disoproxil Fumarate Tablets

Tenofovir Disoproxil Fumarate Tablets of Gilead DRUG

1 blank Domestic Tenofovir Disoproxil Fumarate Tablets and 1Tenofovir Disoproxil Fumarate Tablets of Gilead

Tenofovir Disoproxil Fumarate Tablets of Gilead

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (15)

Beijing Ditan Hospital Capital Medical University

Beijing, Beijing Municipality, 100015, China

RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Beijing You An Hospital, Capital Medical University

Beijing, Beijing Municipality, 100069, China

RECRUITING

First Affiliated Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400039, China

RECRUITING

Third Affiliated Hospital of Sun Yat-sen

Guangzhou, Guangdong, 510630, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

The Second Hospital of Nanjing

Nanjing, Jiangsu, 210003, China

RECRUITING

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201508, China

RECRUITING

West China Hospital of Sichuan University

Chengdou, Sichuan, 610041, China

RECRUITING

First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Related Publications (2)

• Chen XF, Fan YN, Si CW, Yu YY, Shang J, Yu ZJ, Mao Q, Xie Q, Zhao W, Li J, Gao ZL, Wu SM, Tang H, Cheng J, Chen XY, Zhang WH, Wang H, Xu ZN, Wang L, Dai J, Xu JH. Tenofovir disoproxil fumarate in Chinese chronic hepatitis B patients: Results of a multicenter, double-blind, double-dummy, clinical trial at 96 weeks. World J Clin Cases. 2021 Jun 26;9(18):4690-4699. doi: 10.12998/wjcc.v9.i18.4690.

  PMID: 34222435 DERIVED

• Liang RY, Xu JH, Si CW, Wang S, Shang J, Yu ZJ, Mao Q, Xie Q, Zhao W, Li J, Gao ZL, Wu SM, Tang H, Cheng J, Chen XY, Zhang WH, Wang H, Xu ZN, Wang L, Dai J, Yu YY. A randomized, double-blind, double-dummy, controlled, multicenter study of Qingzhong (tenofovir disoproxil fumarate) versus Viread for the treatment of chronic hepatitis B: First-stage results at week 48. Medicine (Baltimore). 2019 Aug;98(33):e16778. doi: 10.1097/MD.0000000000016778.

  PMID: 31415381 DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan yan Yu, doctor

CONTACT

13901194223; yyy@bjnu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2014
• First Posted: November 11, 2014
• Study Start: September 1, 2014
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

CN (15)