Assessment for effect and safety of Tenofovir Disoproxil Fumarate Tablets in the treatment of hepatitis B: a randomized, bouble blinding by double simulation, positive agent, multicenter trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-12002126

Enrollment

Unknown

Registered

2012-04-25

Start date

2012-05-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Chronic hepatitis B

Interventions

A:Oral ADV 10mg/d

B:Tenofovir Disoproxil Fumarate Tablets

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18~60 years; 2. Both gender; 3. Patient with positive finding of HBsAg at least 24 weeks; 4. Patient with positive reaction of HBeAb, HBV-DNA>=10*5 copies/ml, and 10xULN>=ALT>2xULN; or negative HBeAb, HBV-DNA>=10*4 copies/ml, and 10xULN>=ALT>1.5xULN; 5. CHB patient without history of use nucleotides or nucleic acid; 6. To be able to understand and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patient with any evidence supporting the diagnosis of liver cancer; 2. Patient with any clinical symptom of decompensation liver disease: TBil>1.5*ULN, PT delayed>=3 minutes or prothrombin activity 10*ULN or Transient hepatic decompensation resulted from the disease worse

Design outcomes

Primary

Measure	Time frame
Rate of normalization of HBV-DNA;ALT;	—

Countries

China

Contacts

Public ContactCheng Jun

chengj302@hotmail.com+86 010 84322006

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026