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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02826070
Other study ID # MOH-09
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received June 27, 2016
Last updated July 4, 2016
Start date April 2015
Est. completion date October 2017

Study information

Verified date June 2016
Source Nanfang Hospital of Southern Medical University
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate that long-term treatment (up to six years) with telbivudine or telbivudine plus adefovir results in the regression in liver inflammation and fibrosis/cirrhosis.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 130
Est. completion date October 2017
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

1. Patients who completed EFFORT extension study.

2. Patients who had baseline (that is the week 0 of EFFORT study) HBV DNA <9 Log copies/mL and ALT =2×ULN.

3. Patients who are willing to participate in the further extension study.

4. Patient is willing and able to comply with the study drug regimen and all other study requirements.

5. Patients must give written informed consent before any assessment is performed.

Exclusion Criteria:

1. Poor compliance judged by investigators

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Telbivudine
Telbivudine, 600mg, oral, daily
Adefovir dipivoxil
Adefovir dipivoxil 10mg, oral, daily
Other:
off-treatment follow-up


Locations

Country Name City State
China 302 Military Hospital Of China Beijing Beijing
China Beijing Ditan Hospital Beijing Beijing
China BeiJing YouAn Hospital ,Capital Medical University Beijing Beijing
China Department of infectious disease, First Hospital of Peking University Beijing Beijing
China People's Hospital of Beijing University Beijing Beijing
China First Hospital .Jilin Unniversity Changchun Jilin
China Xiangya Hospital Central-South Univrsity Changsha Hunan
China The Second Affiliated of ChongQing University of Medical Science Chongqing Chongqing
China Department of Infectious Disease, Nanfang Hospital Guangzhou Guangdong
China No. 8 People's Hospital In GuangZhou Guangzhou Guangdong
China The Third Hospital of Sun Yat-Sen University Guangzhou Guangdong
China The First Affiliated Hospital of College of Medicine, Zhejiang University Hangzhou Zhejiang
China JiNan Infectious Diseases Hospital Jinan Shandong
China No.81 Hospital of PLA Nanjing Jiangsu
China Changhai Hospital affiliated to Second Military Medical University Shanghai Shanghai
China Huashan Hospital,Fudan University Shanghai Shanghai
China Shanghai Ruijin Hospital Shanghai Shanghai
China ShengJing Hospital of China Medical University Shengyang Liaoning
China Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei
China Tangdu Hospital XiAn Shanxi

Sponsors (3)

Lead Sponsor Collaborator
Nanfang Hospital of Southern Medical University Major Science and Technology Special Project of China Twelfth-Five-Year Project, Novartis

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients with histological improvement (=2-point decrease in the Knodell necroinflammatory score and no worsening in Ishak fibrosis score). Week 48 No
Secondary Percentage of patients achieving hepatitis B virus (HBV) DNA <300copies/mL at week 48 and 96 in on-treatment group week 48, week 96 No
Secondary Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48 and 96 in on-treatment group week 48, week 96 No
Secondary Percentage of patients with HBsAg loss or HBsAg seroconversion at week 48 and 96 in on-treatment group week 48, week 96 No
Secondary The percentage of patients with alanine aminotransferase (ALT) normalization at week 48 and 96 in on-treatment group week 48, week 96 No
Secondary Percentage of patients with HBV DNA breakthrough at week 48 and 96 in on-treatment group week 48, week 96 No
Secondary Percentage of patients with genotypic resistance among the patients with HBV DNA breakthrough at week 48 and 96 in on-treatment group week 48, week 96 No
Secondary Incidence of adverse effect at week 48 and 96 in on-treatment group week 48, week 96 No
Secondary Percentage of patients with glomerular filtration rate (GFR) shifting to >90 mL/min/1.73 m2 for patients with GFR <90 mL/min/1.73 m2 at baseline of EFFORT study at week 48 and 96 in on-treatment group week 48, week 96 No
Secondary Sustained response rate of durability of HBeAg seroconversion at week 48 and 96 in off-treatment group week 48, week 96 No
Secondary Percentage of patients who re-achieved ALT normalization and HBV DNA <300 copies/mL in the patients retreated who developed hepatitis flare after stopping treatment in off-treatment group week 96 No
Secondary Incidence of abnormal laboratory examination at week 48 and 96 in on-treatment group week 48, week 96 No
Secondary Percentage of hepatitis flare at week 48 and 96 in off-treatment group week 48, week 96 No
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