- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04071353
Observational Cohort Study of Clinical Outcomes After Antiviral Therapy for Chronic Hepatitis C
August 25, 2019 updated by: Yao Xie, Beijing Ditan Hospital
Observational Cohort Study of Clinical Outcomes After Antiviral Therapy in Chronic Hepatitis C Patients
This study was a clinical observational cohort study of two-way, non-intervention long-term dynamic follow-up.
Enrolled in the Department of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, with interferon combined with ribavirin (PR) antiviral therapy (PR treatment greater than or equal to 6 months) and/or direct acting antivirals (DAAs) In patients with chronic hepatitis C, the baseline, antiviral treatment and withdrawal follow-up data before the antiviral treatment were collected, and the patients were followed up for 3-6 months.
Clinical data such as clinical biochemistry, HCV RNA and serological markers (anti-HCV), AFP and liver imaging (liver ultrasound) were collected during the study period.
At least 144 weeks of observation on the virological response and clinical outcome of anti-viral treatment of chronic hepatitis C, the main evaluation index of liver cancer and decompensated liver cirrhosis after stopping the drug, and exploring the antiviral treatment of patients Long-term virological response and clinical outcomes, clarifying their influencing factors.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This study was a clinical observational cohort study of two-way, non-intervention long-term dynamic follow-up.
Enrolled in the Department of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, with interferon combined with ribavirin (PR) antiviral therapy (PR treatment greater than or equal to 6 months) and/or direct acting antivirals (DAAs) In patients with chronic hepatitis C, the baseline, antiviral treatment and withdrawal follow-up data before the antiviral treatment were collected, and the patients were followed up for 3-6 months.
Clinical data such as clinical biochemistry, HCV RNA and serological markers (anti-HCV), AFP and liver imaging (liver ultrasound) were collected during the study period.
At least 144 weeks of observation on the virological response and clinical outcome of anti-viral treatment of chronic hepatitis C, the main evaluation index of liver cancer and decompensated liver cirrhosis after stopping the drug, and exploring the antiviral treatment of patients Long-term virological response and clinical outcomes, clarifying their influencing factors.
Study Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100015
- Recruiting
- liver disease center, Beijing Ditan Hospital
-
Contact:
- Yao Xie, phD/MD
- Phone Number: 2489 8610-84322200
- Email: xieyao@public.nta.net.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Chronic hepatitis C patients treated with interferon plus ribavirin (PR) antiviral therapy (PR treatment greater than or equal to 6 months) and/or direct antiviral drugs (DAAs).
All patients with chronic hepatitis C were eligible for the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis C (2015).
Description
Inclusion Criteria:
- Chronic hepatitis C patients treated with interferon plus ribavirin (PR) antiviral therapy (PR treatment greater than or equal to 6 months) and/or direct antiviral drugs (DAAs)
Exclusion Criteria:
- Co-infected with hepatitis B virus or human immunodeficiency virus
- Had an autoimmune disease, liver tumour, or severe cardiac disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Interferon combined with ribavirin group
Interferon combined with ribavirin (PR) antiviral therapy (PR treatment for 6 months or more) in patients with chronic hepatitis C, collect basic data before antiviral therapy, and during the PR antiretroviral treatment period, Follow-up was performed every 3-6 months in March, June, September, December, DAAs antiviral treatment during January, March, and withdrawal follow-up, and clinical biochemistry, HCV RNA, and serological markers were used during follow-up ( anti-HCV), AFP and liver imaging (liver ultrasound) examination.
|
Interferon combined with ribavirin antiviral therapy
Interferon combined with ribavirin antiviral therapy
|
DAAs treatment group
Patients with chronic hepatitis C treated with direct acting antivirals (DAAs), collect basic data before antiviral therapy, and during the period of PR antiviral treatment, January, March, June, September, December Follow-up was performed every 3-6 months during January, March, and withdrawal follow-up during DAAs antiviral therapy.
Clinical biochemistry, HCV RNA and serological markers (anti-HCV), AFP, and liver imaging were performed at follow-up.
Liver ultrasound) check.
|
DAAs antiviral treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of liver cancer
Time Frame: up to 144 weeks
|
The incidence of liver cancer after anti-viral treatment of chronic hepatitis C
|
up to 144 weeks
|
The incidence of decompensated cirrhosis
Time Frame: up to 144 weeks
|
The incidence of decompensated cirrhosis after anti-viral treatment of chronic hepatitis C
|
up to 144 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of persistent virological response or relapse
Time Frame: up to 144 weeks
|
Percentage of persistent virological response or relapse after antiviral therapy for chronic hepatitis C
|
up to 144 weeks
|
Related factors of liver cancer
Time Frame: up to 144 weeks
|
Related factors including viral indicators (HCV RNA content, anti-HCV), clinical biochemical indicators (ALT, AST, ALB, Tbil), blood routine and coagulation function indicators (PTA) and serum AFP and liver ultrasound results of liver cancer after anti-viral treatment of chronic hepatitis C
|
up to 144 weeks
|
Related factors of decompensated cirrhosis
Time Frame: up to 144 weeks
|
Related factors including viral indicators (HCV RNA content, anti-HCV), clinical biochemical indicators (ALT, AST, ALB, Tbil), blood routine and coagulation function indicators (PTA) and serum AFP and liver ultrasound results of decompensated cirrhosis after anti-viral treatment of chronic hepatitis C
|
up to 144 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Yao Xie, phD/MD, Beijing Ditan Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2019
Primary Completion (Anticipated)
August 1, 2020
Study Completion (Anticipated)
August 1, 2020
Study Registration Dates
First Submitted
August 18, 2019
First Submitted That Met QC Criteria
August 25, 2019
First Posted (Actual)
August 28, 2019
Study Record Updates
Last Update Posted (Actual)
August 28, 2019
Last Update Submitted That Met QC Criteria
August 25, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis, Chronic
- Hepatitis C, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Antineoplastic Agents
- Interferons
- Ribavirin
Other Study ID Numbers
- DTXY021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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