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Real World Study of Chronic Viral Hepatitis
| Condition or disease |
|---|
| Hepatitis, Chronic |
Chronic viral hepatitis is defined as infectious liver disease caused by persistent virus infection for more than six months. Sustained viral replication and ongoing liver inflammation can eventually lead to liver fibrosis/cirrhosis or even hepatocellular carcinoma. Chronic viral hepatitis infection causes at least 80% of all liver cancers.
Though chronic viral hepatitis is a major global health concern, there is still a lack of evidence in high quality about the management of chronic viral hepatitis and the long-term outcome of patients. The concept of real-world data and research has been officially introduced into China since 2010. Real-world evidence, based on real-world data, can help practitioners have better understanding of the characteristics of the patients with different treatment strategies.
This study is aimed to collect and analyze clinical data of patients with chronic viral hepatitis in the real world, to investigate the long-term outcome of these patients and to optimize treatment options based on these data.
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 10000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 5 Years |
| Official Title: | Real World Study of Chronic Viral Hepatitis |
| Estimated Study Start Date : | July 20, 2019 |
| Estimated Primary Completion Date : | August 1, 2024 |
| Estimated Study Completion Date : | August 1, 2029 |
| Group/Cohort |
|---|
|
chronic hepatitis B
No intervention. The clinical data of patients (including demographic information, details of antiviral therapy, imaging and laboratory testings) will be collected and analyzed.
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chronic hepatitis C
No intervention. The clinical data of patients (including demographic information, details of antiviral therapy, imaging and laboratory testings) will be collected and analyzed.
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- Virologic responses(for both chronic hepatitis B and C) [ Time Frame: 24 weeks after treatment initiation ]Sustained virological response （Able to sustain an undetectable viral load for a period）
- Serological responses(for chronic hepatitis B only) [ Time Frame: 48 weeks after treatment initiation ]Hepatitis B e antigen (HBeAg) seroconversion(HBeAg loss and presence of anti-HBe) and hepatitis B surface antigen(HBsAg) seroconversion (HBsAg loss and presence of anti-HBs)
- Histological responses(for both chronic hepatitis B and C) [ Time Frame: 48 weeks after treatment initiation ]Significant improvement in fibrosis was defined as a decrease in the Ishak score of at least 1 point; (the Ishak score describes six stages of fibrosis, 0 for No fibrosis and 6 for Cirrhosis; higher the Ishak score is, more severe the fibrosis is).
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Informed consent of patients.
- Evidence of persistent virus infection for greater than six months [hepatitis C virus(HCV) RNA positive, hepatitis B surface antigen(HBsAg) or hepatitis B virus(HBV) DNA positive]
Exclusion Criteria:
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Serious psychiatric history, especially depression.
- Severe mental illness is defined as major depression or psychosis, suicide attempts, hospitalization due to mental illness or a period of disability due to mental illness.
- Patients with serious diseases of heart, lung, kidney, brain, blood and other important organs.
- Patients with malignant tumors (excluding those cured).
| Contact: Yiqi Yu, Doctor | 13601637563 ext 02152887969 | yyq19890619@126.com |
| China, Shanghai | |
| Huashan Hospital | Recruiting |
| Shanghai, Shanghai, China, 200000 | |
| Contact: Yiqi Yu, doctor 13601637563 yyq19890619@126.com | |
| Study Chair: | Wenhong Zhang, Professor | Huashan Hospital |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | July 7, 2019 | ||||||
| First Posted Date | July 19, 2019 | ||||||
| Last Update Posted Date | July 19, 2019 | ||||||
| Estimated Study Start Date | July 20, 2019 | ||||||
| Estimated Primary Completion Date | August 1, 2024 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||||
| Change History | No Changes Posted | ||||||
| Current Secondary Outcome Measures |
Histological responses(for both chronic hepatitis B and C) [ Time Frame: 48 weeks after treatment initiation ] Significant improvement in fibrosis was defined as a decrease in the Ishak score of at least 1 point; (the Ishak score describes six stages of fibrosis, 0 for No fibrosis and 6 for Cirrhosis; higher the Ishak score is, more severe the fibrosis is).
|
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| Original Secondary Outcome Measures | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | Real World Study of Chronic Viral Hepatitis | ||||||
| Official Title | Real World Study of Chronic Viral Hepatitis | ||||||
| Brief Summary | This study is aimed to collect and analyze clinical data of patients with chronic viral hepatitis in the real world, to investigate the long-term outcome of these patients and to optimize treatment options based on these data. | ||||||
| Detailed Description |
Chronic viral hepatitis is defined as infectious liver disease caused by persistent virus infection for more than six months. Sustained viral replication and ongoing liver inflammation can eventually lead to liver fibrosis/cirrhosis or even hepatocellular carcinoma. Chronic viral hepatitis infection causes at least 80% of all liver cancers. Though chronic viral hepatitis is a major global health concern, there is still a lack of evidence in high quality about the management of chronic viral hepatitis and the long-term outcome of patients. The concept of real-world data and research has been officially introduced into China since 2010. Real-world evidence, based on real-world data, can help practitioners have better understanding of the characteristics of the patients with different treatment strategies. This study is aimed to collect and analyze clinical data of patients with chronic viral hepatitis in the real world, to investigate the long-term outcome of these patients and to optimize treatment options based on these data. |
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| Study Type | Observational [Patient Registry] | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | 5 Years | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Non-Probability Sample | ||||||
| Study Population | Patients with chronic viral hepatitis. | ||||||
| Condition | Hepatitis, Chronic | ||||||
| Intervention | Not Provided | ||||||
| Study Groups/Cohorts |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Recruiting | ||||||
| Estimated Enrollment |
10000 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Estimated Study Completion Date | August 1, 2029 | ||||||
| Estimated Primary Completion Date | August 1, 2024 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 75 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | Not Provided | ||||||
| Contacts |
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| Listed Location Countries | China | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT04025944 | ||||||
| Other Study ID Numbers | KY2019-RWS(CVH) | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Wen-hong Zhang, Huashan Hospital | ||||||
| Study Sponsor | Huashan Hospital | ||||||
| Collaborators | Not Provided | ||||||
| Investigators |
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| PRS Account | Huashan Hospital | ||||||
| Verification Date | July 2019 | ||||||
