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

Chronic Hepatitis B Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02287857
• Other study ID #: CTTQ-TDF-V4.0
• Status: Recruiting
• Phase: N/A
• Start date: September 2014
• Est. completion date: October 2019

Study information

• Verified date: March 2019
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Yan yan Yu, doctor
• Phone: 13901194223
• Email: yyy[@]bjnu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Domestic Tenofovir Disoproxil Fumarate Tablets
1 Domestic Tenofovir Disoproxil Fumarate Tablets and 1 blank Tenofovir Disoproxil Fumarate Tablets of Gilead
• Tenofovir Disoproxil Fumarate Tablets of Gilead
1 blank Domestic Tenofovir Disoproxil Fumarate Tablets and 1Tenofovir Disoproxil Fumarate Tablets of Gilead

Locations

Country	Name	City	State
China	Beijing Ditan Hospital Capital Medical University	Beijing	Beijing
China	Beijing You An Hospital, Capital Medical University	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	West China Hospital of Sichuan University	Chengdou	Sichuan
China	First Affiliated Hospital, Third Military Medical University	Chongqing	Chongqing
China	Third Affiliated Hospital of Sun Yat-sen	Guangzhou	Guangdong
China	First Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	The Second Hospital of Nanjing	Nanjing	Jiangsu
China	Huashan Hospital, Fudan University	Shanghai	Shanghai
China	Ruijin Hospital Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Shanghai Public Health Clinical Center	Shanghai	Shanghai
China	First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compared with baseline, decline of serum HBV-DNA in the value		48 week