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EFFORT Further Extension Study

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ClinicalTrials.gov Identifier: NCT02826070
Recruitment Status : Unknown
Verified June 2016 by Nanfang Hospital of Southern Medical University.
Recruitment status was:  Active, not recruiting
First Posted : July 7, 2016
Last Update Posted : July 7, 2016
Sponsor:
Collaborators:
Major Science and Technology Special Project of China Twelfth-Five-Year Project
Novartis
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: Telbivudine Drug: Adefovir dipivoxil Other: off-treatment follow-up Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Long-term Telbivudine Treatment on Histological Improvements in Patients With Chronic Hepatitis B (EFFORT Further Extension Study)
Study Start Date : April 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Off-treatment
Patients who had stopped treatment during EFFORT extension study could receive 2-year off-treatment follow-up. All the patients in Part I will be followed up at the interval of 12 weeks. For these patients, if they have hepatitis flare during follow-up, they will be re-treated with telbivudine combined with adefovir for the left study period ( the total study period is 2 years) and followed up at the interval of 12 weeks. Hepatitis flare is defined as HBV DNA>4 Log10 copies/mL with either ALT≥5 times upper limit of normal (ULN) or TBIL≥2×ULN,or 2 ≤ALT ≤5 ×ULN (at two consecutive visits at least 2 weeks apart) and total bilirubin (TBIL) <2×ULN.
Other: off-treatment follow-up
On-treatment
Patients with continuous treatment during EFFORT extension study will continue treatment, without off-treatment rule in the further extension study. The treatment strategy is depended on the HBV DNA level of each individual, that is, for patients with negative HBV DNA level (defined as HBV DNA <20 IU/mL) will continue their previous treatment strategy; and for patients with positive HBV DNA level (defined as HBV DNA>=20 IU/mL) will receive the combination therapy of telbivudine and adefovir, irrespective of their previous treatment strategy. All the patients in Part II will be followed up at the interval of 24 weeks until they complete the 2-year on-treatment follow-up. Patients will be conducted liver biopsy at the sixth year of treatment. All the patients with telbivudine monotherapy will be switched to telbivudine plus adefovir once confirmed HBV DNA breakthrough developed.
Drug: Telbivudine
Telbivudine, 600mg, oral, daily

Drug: Adefovir dipivoxil
Adefovir dipivoxil 10mg, oral, daily




Primary Outcome Measures :
  1. Percentage of patients with histological improvement (≥2-point decrease in the Knodell necroinflammatory score and no worsening in Ishak fibrosis score). [ Time Frame: Week 48 ]

Secondary Outcome Measures :
  1. Percentage of patients achieving hepatitis B virus (HBV) DNA <300copies/mL at week 48 and 96 in on-treatment group [ Time Frame: week 48, week 96 ]
  2. Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48 and 96 in on-treatment group [ Time Frame: week 48, week 96 ]
  3. Percentage of patients with HBsAg loss or HBsAg seroconversion at week 48 and 96 in on-treatment group [ Time Frame: week 48, week 96 ]
  4. The percentage of patients with alanine aminotransferase (ALT) normalization at week 48 and 96 in on-treatment group [ Time Frame: week 48, week 96 ]
  5. Percentage of patients with HBV DNA breakthrough at week 48 and 96 in on-treatment group [ Time Frame: week 48, week 96 ]
  6. Percentage of patients with genotypic resistance among the patients with HBV DNA breakthrough at week 48 and 96 in on-treatment group [ Time Frame: week 48, week 96 ]
  7. Incidence of adverse effect at week 48 and 96 in on-treatment group [ Time Frame: week 48, week 96 ]
  8. 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 [ Time Frame: week 48, week 96 ]
  9. Sustained response rate of durability of HBeAg seroconversion at week 48 and 96 in off-treatment group [ Time Frame: week 48, week 96 ]
  10. 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 [ Time Frame: week 96 ]
  11. Incidence of abnormal laboratory examination at week 48 and 96 in on-treatment group [ Time Frame: week 48, week 96 ]
  12. Percentage of hepatitis flare at week 48 and 96 in off-treatment group [ Time Frame: week 48, week 96 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826070


Locations
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China, Beijing
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
China, Chongqing
The Second Affiliated of ChongQing University of Medical Science
Chongqing, Chongqing, China
China, Guangdong
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
China, Hubei
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
China, Hunan
Xiangya Hospital Central-South Univrsity
Changsha, Hunan, China
China, Jiangsu
No.81 Hospital of PLA
Nanjing, Jiangsu, China
China, Jilin
First Hospital .Jilin Unniversity
Changchun, Jilin, China
China, Liaoning
ShengJing Hospital of China Medical University
Shengyang, Liaoning, China
China, Shandong
JiNan Infectious Diseases Hospital
Jinan, Shandong, China
China, Shanghai
Changhai Hospital affiliated to Second Military Medical University
Shanghai, Shanghai, China
Huashan Hospital,Fudan University
Shanghai, Shanghai, China
Shanghai Ruijin Hospital
Shanghai, Shanghai, China
China, Shanxi
Tangdu Hospital
XiAn, Shanxi, China
China, Zhejiang
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Major Science and Technology Special Project of China Twelfth-Five-Year Project
Novartis
Investigators
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Principal Investigator: Jinlin Hou Nanfang Hospital of Southern Medical University

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Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT02826070     History of Changes
Other Study ID Numbers: MOH-09
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Nanfang Hospital of Southern Medical University:
Chronic Hepatitis B

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Adefovir
Adefovir dipivoxil
Telbivudine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents