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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02287857
Enrollment
360
Registered
2014-11-11
Start date
2014-09-30
Completion date
2019-10-31
Last updated
2019-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

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.

Interventions

DRUGDomestic Tenofovir Disoproxil Fumarate Tablets

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

DRUGTenofovir Disoproxil Fumarate Tablets of Gilead

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

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Compared with baseline, decline of serum HBV-DNA in the value48 week

Countries

China

Contacts

Primary ContactYan yan Yu, doctor
yyy@bjnu.edu13901194223

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026