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Effect of Entecavir Treatment on Regression and Disease Outcome in HBV-induced Liver Fibrosis and Cirrhosis Patients

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ClinicalTrials.gov Identifier: NCT02849132
Recruitment Status : Active, not recruiting
First Posted : July 29, 2016
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Hong You, Beijing Friendship Hospital

Brief Summary:
Patients who have completed 2-years entecavir-based treatment in Regress Study will receive another 5-years entecavir extension therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan; A third liver biopsy will be performed at year 3 in patients who have significant fibrosis at second biopsy. CT and endoscopy will be performed at baseline and year 3.

Condition or disease Intervention/treatment Phase
Hepatitis B Liver Cirrhosis Drug: Entecavir Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Entecavir Treatment on Regression and Long-term Disease Outcome in Patients With HBV-induced Liver Fibrosis and Cirrhosis (Regress Extension Study)
Study Start Date : January 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis
Drug Information available for: Entecavir

Arm Intervention/treatment
Experimental: Treatment group
entecavir oral,0.5mg daily for 5 years
Drug: Entecavir
oral entecavir 0.5mg daily for 5 years




Primary Outcome Measures :
  1. Fibrosis regression rate [ Time Frame: year 3 ]
    Ishak fibrosis score decrease more than 1 stage after 3 years treatment

  2. Cumulative incidence of liver decompensation [ Time Frame: year 5 ]
    Cumulative incidence of liver decompensation (including ascites, hepatic encephalopathy, esophageal varices bleeding and Hepatocellular Carcinoma) and death after 5 years treatment


Secondary Outcome Measures :
  1. Virological response [ Time Frame: year 1, 3 and 5 ]
    Percentage of patients achieving hepatitis B virus (HBV) DNA < 20IU/mL at year 1, 3 and 5

  2. Aminotransferase response [ Time Frame: year 1, 3 and 5 ]
    The percentage of patients with alanine aminotransferase (ALT) normalization at year 1, 3 and 5

  3. HBeAg loss or HBeAg seroconversion [ Time Frame: year 1, 3 and 5 ]
    Percentage of patients with HBeAg loss or HBeAg seroconversion at year 1, 3 and 5

  4. HBsAg loss or HBsAg seroconversion rate [ Time Frame: year 1, 3 and 5 ]
    Percentage of patients with HBsAg loss or HBsAg seroconversion at year 1, 3 and 5

  5. Dynamic changes of Child-Pugh score [ Time Frame: year 1, 3 and 5 ]
    Dynamic changes of Child-Pugh score after 1, 3 and 5 years of treatment

  6. Dynamic changes of MELD score [ Time Frame: year 1, 3 and 5 ]
    Dynamic changes of MELD score after 1, 3 and 5 years of treatment

  7. Dynamic changes of liver stiffness values measured by Transient Elastography [ Time Frame: year 1, 3 and 5 ]
    Dynamic changes of liver stiffness values after 1, 3 and 5 years of treatment

  8. Improvement of life quality (SF36 and EQ-5D) [ Time Frame: year 1, 3 and 5 ]
    Improvement of life quality after 1, 3 and 5 years of treatment



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Subjects who completed the 2 years of entecavir-based therapy in Regress study; Subjects who are willing to participate the extension study.

Exclusion Criteria:

- Any complication of severe heart, lung, kidney, brain, blood diseases or other important systematic diseases; Pregnant women; Subjects who could not compliance with the protocol judged by investigators; Subjects who are not suitable for the study 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): NCT02849132


Locations
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China, Beijing
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing, China, 100015
Peking University First Hospital
Beijing, Beijing, China, 100034
302 Military Hospital Of China
Beijing, Beijing, China, 100039
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing, China, 100050
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing, China, 100050
Peking University People's Hospital
Beijing, Beijing, China, 100050
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing, China, 100069
Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
Peking University
Beijing, Beijing, China, 100871
China, Guangdong
NanfangHospital,Southern Medical University
Guangzhou, Guangdong, China, 510515
China, Hebei
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050051
Shijiazhuang Fifth Hospital
Shijiazhuang, Hebei, China, 50021
China, Hubei
Tongji Hospital, Tongji Medical College , Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
China, Jilin
The Affiliated Hospital of Yanbian University
Yanji, Jilin, China, 133000
China, Shanghai
Renji Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai, China, 200032
Huashan Hospital FuDan University
Shanghai, Shanghai, China, 200040
Zhongshan Hospital Fudan University
Shanghai, Shanghai, China, 200040
Shanghai General Hospital
Shanghai, Shanghai, China, 200080
Shanghai Public Health Clinical Center
Shanghai, Shanghai, China, 201508
China, Shanxi
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 30001
Xijing Hospital, Fourth Military Medical University
Xi'an, Shanxi, China, 710032
China, Tianjin
The Hospital Affiliated to Logistics University of Chinese People's Armed Police Force
Tianjin, Tianjin, China, 300162
China, Zhejiang
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310016
China
Tianjin Third Central Hospital
Tianjin, China, 300170
Sponsors and Collaborators
Beijing Friendship Hospital
Investigators
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Principal Investigator: Hong You, Doctor Beijing Friendship Hospital

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Responsible Party: Hong You, Vice-Director of Liver Research Center, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT02849132     History of Changes
Other Study ID Numbers: 2016ZX10002011
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Hepatitis B
Liver Cirrhosis
Fibrosis
Hepatitis
Liver Diseases
Digestive System Diseases
Pathologic Processes
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Entecavir
Antiviral Agents
Anti-Infective Agents