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Trial record 9 of 9 for:    "Liver Cirrhosis" | "Telbivudine"

Improvement of Hard Endpoint in Chronic Hepatitis B Patients Treated With Antiviral Therapy

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ClinicalTrials.gov Identifier: NCT03366571
Recruitment Status : Recruiting
First Posted : December 8, 2017
Last Update Posted : December 8, 2017
Sponsor:
Collaborators:
Peking University First Hospital
Peking University People's Hospital
Beijing YouAn Hospital
Beijing Tiantan Hospital
Beijing Ditan Hospital
Beijing 302 Hospital
Peking Union Medical College Hospital
China-Japan Friendship Hospital
Information provided by (Responsible Party):
Jidong Jia, Beijing Friendship Hospital

Brief Summary:
Patients who have completed 3 years follow-up of the past Beijing Science and Technology Commission Research will receive another 2-years anti-viral 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. CT or MRI and endoscopy will be performed at baseline and 3 years. At the end of the study, the cumulative rate of clinical hepatic hard endpoint will be calculated.

Condition or disease Intervention/treatment
Chronic Hepatitis B Drug: Nucleos(t)ide Analogues

Detailed Description:
Patients who have completed 3 years follow-up of the past Beijing Science and Technology Commission Research will receive another 2-years anti-viral 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. CT or MRI and endoscopy will be performed at baseline and 3 years. At the end of the study, the cumulative rate of clinical hepatic hard endpoint will be calculated.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improvement of Hard Endpoint in Chronic Hepatitis B Patients Treated With Antiviral Therapy
Study Start Date : January 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Anti-viral therapy group
Subjects who have completed the 3 years research "Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis"
Drug: Nucleos(t)ide Analogues
Entecavir 0.5mg daily for no less than 5 years ;Lamivudine:100mg qd daily for no less than 5 years; Adefovir Dipivoxil:10mg daily for no less than 5; years;telbivudine:600mg qd daily for no less than 5 years; or their combination therapy for no less than 5 years
Other Name: Baraclude , et al

Non anti-viral therapy group
History study from literature



Primary Outcome Measures :
  1. Cumulative rate of liver decompensation and/or hepatic carcinoma and/or liver related death [ Time Frame: 5 years ]
    Cumulative rate of liver decompensation (including ascites,hepatic encephalopathy,Gastrointestinal hemorrhage),and/or hepatocellular carcinoma, and/or liver related death after 5 years of antiviral treatment


Secondary Outcome Measures :
  1. HBV-DNA undetectable rate [ Time Frame: 5 years ]
    HBV-DNA undetectable rate after 5 years of antiviral treatment

  2. Decrease of transient elastography [ Time Frame: 5 years ]
    Decrease of transient elastography after 5 years of antiviral treatment

  3. HBeAg seroconversion rate [ Time Frame: 5 years ]
    HBeAg seroconversion rate after 5 years of antiviral treatment

  4. HBsAg seroconversion rate [ Time Frame: 5 years ]
    HBsAg seroconversion rate after 5 years of antiviral treatment

  5. Decrease of Child-Pugh score [ Time Frame: 5 years ]
    Decrease of Child-Pugh score after 5 years of antiviral treatment

  6. Decrease of MELD score [ Time Frame: 5 years ]
    Decrease of MELD score after 5 years of antiviral treatment

  7. Improvement of life Quality assessed by SF-36 [ Time Frame: 5 years ]
    Improvement of life Quality assessed by SF-36 after 5 years of antiviral treatment

  8. Improvement of life Quality assessed by EQ-5D [ Time Frame: 5 years ]
    Improvement of life Quality assessed by EQ-5D after 5 years of antiviral treatment


Biospecimen Retention:   Samples With DNA
serum,plasma and DNA


Information from the National Library of Medicine

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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
Sampling Method:   Non-Probability Sample
Study Population
The HBV-related chronic hepatitis /cirrhosis patients who have completed 3 years follow-up of the past Beijing Science and Technology Commission Research.
Criteria

Inclusion Criteria:

  • Patients who have participated in the research funded by Beijing science and Technology Commission and have completed 156 weeks follow-up.
  • Patients comply with the requirements of the trail voluntarily
  • Written informed consent

Exclusion Criteria:

  • Pregnant woman or patient with severe disease
  • Patients with poor adherence to the study
  • Patients not suitable for the study evaluated by the investigator

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): NCT03366571


Contacts
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Contact: Dong J Jia, Doctor jiamd@263.net
Contact: Jialing Zhou, doctor 010-63138665 zhoujialing11@126.com

Locations
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China, Beijing
China-Japan Friendship Hospital Recruiting
Beijing, Beijing, China, 100029
Contact: Anlin Ma, Doctor    13910253710    maanlinjc@163.com   
Principal Investigator: Anlin Ma, Doctor         
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Xiaoyuan Xu, Doctor    13001185762    xiaoyuanxu6@163.com   
Principal Investigator: Xiaoyuan Xu, Doctor         
Beijing 302 Hospital Recruiting
Beijing, Beijing, China
Contact: Feng G Chen       bjchen302@aliyun.com   
Principal Investigator: Feng G Chen         
Beijing Ditan Hospital Recruiting
Beijing, Beijing, China
Contact: Wen Xie         
Beijing Tiantan Hospital Recruiting
Beijing, Beijing, China
Contact: Qing Y Xu         
Beijing YouAn Hospital Recruiting
Beijing, Beijing, China
Contact: Guo H Ding, Doctor    8613699119545    lilei_1978@aliyun.com   
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China
Contact: Qing X Liu         
PeKing University People's Hopital Recruiting
Beijing, Beijing, China
Contact: Hui Ma, Doctor    8613671090481    mahui_wj@163.com   
Sponsors and Collaborators
Beijing Friendship Hospital
Peking University First Hospital
Peking University People's Hospital
Beijing YouAn Hospital
Beijing Tiantan Hospital
Beijing Ditan Hospital
Beijing 302 Hospital
Peking Union Medical College Hospital
China-Japan Friendship Hospital
Investigators
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Principal Investigator: Dong J Jia, Doctor Beijing Friendship Hospital

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Responsible Party: Jidong Jia, Director of Liver Research Center, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT03366571     History of Changes
Other Study ID Numbers: D161100002716003
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jidong Jia, Beijing Friendship Hospital:
Liver Cirrhosis
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Anti-Infective Agents