Emtricitabine for Naive Chinese Chronic Hepatitis B Patients

December 29, 2014 updated by: Jun Cheng, Asian-Pacific Alliance of Liver Disease, Beijing
This study evaluates generic emtricitabine(FTC) in Chinese naive chronic hepatitis B patients. Patients were divided into 2 groups: HBeAg positive Chronic hepatitis B(CHB)group and HBeAg negative Chronic hepatitis B(CHB)group.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Generic emtricitabine(FTC) has been approved for treatment of naive chronic hepatitis B(CHB) patients in China. Yet data are limited for this agent. The investigators design this trial to test the effect of FTC in Chinese CHB which including naive HBeAg positive and Negative CHB patients. Response guided therapy strategy is adopted for patients who can not achieve HBV DNA negativity at week 24 FTC treatment, which means FTC and adefovir are combined for these patients.

Study Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HBsAg positive for more than 6 months
  • HBeAg positive patients: HBV DNA ≥ 5log10 copies/ml
  • HBeAg postive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4
  • HBeAg negative patients: HBV DNA ≥ 4log10 copies/ml
  • HBeAg postive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4
  • nucleoside/nucleotide naive paitents

Exclusion Criteria:

  • Diagnosed HCC with AFP and ultrasound, CT or MRI
  • Creatine >130μmol/L or Ccr < 70mL/min
  • Hemoglobin <100g/L
  • Neutrophils <1.5E+9/L
  • PLT<80E+9/L
  • Coinfected with HAV,HEV,HCV,HDV or HIV
  • ANA > 1:100
  • Uncontrolled cardiovascluar diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer
  • Drug abuse or alcohal addiction
  • Previous history of taking agents of lamivudine, adefovir, tenofovir entecavir or telbivudine
  • Long-term use of immunosuppressor or immunomodulator 6 months before enrollment to this trial
  • Underwent liver transplantation or liver transplantation in schedule
  • Allergic to nucleoside or nucleotide analogues
  • Preganency or in breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HBeAg positive CHB group
1000 patients take generic emtricitabine capsule(200 mg one time per day) for 96 weeks,and for patients who have HBV DNA > 500 copies/ml, adefovir dipivoxil were combined
Drug: Emtricitabine
emtricitabine were given to each patients at baseline and respoonse guided therapy was adopted according HBV DNA level at week 24
Other Names:
  • Brand name：Huierding
Experimental: HBeAg negativie CHB group
1000 patients take generic emtricitabine capsule(200 mg one time per day) for 96 weeks,and for patients who have HBV DNA > 500 copies/ml, adefovir dipivoxil were combined
Drug: Emtricitabine
emtricitabine were given to each patients at baseline and respoonse guided therapy was adopted according HBV DNA level at week 24
Other Names:
  • Brand name：Huierding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
virological response rate
Time Frame: week 96
HBV DNA < 500 copies/ml
week 96

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HBV DNA decrease level
Time Frame: week24, 48, 72 and 96
HBV DNA decrease compared with baseline（log10 copies/ml）
week24, 48, 72 and 96
HBV DNA negativity rate
Time Frame: week 24, 48 and 72
HBV DNA < 500 copies/ml
week 24, 48 and 72
biochemical response
Time Frame: week 24,48,72 and 96
ALT normalization
week 24,48,72 and 96
HBeAg loss
Time Frame: week 24,48,72 and 96
HBeAg loss in HBeAg positive group
week 24,48,72 and 96
HBeAg seroconversion
Time Frame: week 24,48,72 and 96
HBeAg seroconversion in HBeAg positive group
week 24,48,72 and 96
HBeAg reversion
Time Frame: week 24,48,72 and 96
HBeAg positive in Baseline HBeAg negativie group patients
week 24,48,72 and 96
HBsAg loss
Time Frame: week 24,48,72 and 96
HBsAg loss in both group
week 24,48,72 and 96
HBsAg seroconversion
Time Frame: week 24,48,72 and 96
HBsAg loss and anti-HBs positive
week 24,48,72 and 96
adverse event
Time Frame: week 24,48,72 and 96
type and rate of adverse events;type and rate of severe adverse event;
week 24,48,72 and 96
HBV genetic resistance to emtricitabine and adefovir
Time Frame: week 24,48,72 and 96
HBV genetic resistance to emtricitabine and adefovir
week 24,48,72 and 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asian-Pacific Alliance of Liver Disease, Beijing

Collaborators

Beijing Ditan Hospital
National Health and Family Planning Commission, P.R.China
Hebei Medical University Pharmaceutical Factory

Investigators

  • Principal Investigator: Jun Cheng, M.D., Asian Pacific Alliance of Liver Diseases, Beijing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

December 23, 2014

First Submitted That Met QC Criteria

December 29, 2014

First Posted (Estimate)

December 30, 2014

Study Record Updates

Last Update Posted (Estimate)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 29, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FTC-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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