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Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Positive Hepatitis B (China)

NCT02836249 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2024-10-15

Study results available
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Summary

The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B virus (HBV) infection in China.

Conditions

  • HBV
  • Chronic HBV Infection

Interventions

DRUG

TAF

TAF 25 mg tablet administered orally once daily

DRUG

TDF

TDF 300 mg tablet administered orally once daily

DRUG

TAF Placebo

TAF placebo tablet administered orally once daily

DRUG

TDF Placebo

TDF placebo tablet administered orally once daily

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-19
Primary Completion
2017-03-21
Completion
2023-08-31
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02836249 on ClinicalTrials.gov