EFFORT Further Extension Study

Hepatitis B, Chronic Clinical Trial

Official title:

Efficacy of Long-term Telbivudine Treatment on Histological Improvements in Patients With Chronic Hepatitis B (EFFORT Further Extension Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02826070
• Other study ID #: MOH-09
• 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

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

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