- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04301882
An Observational Cohort Study of Clinical Outcomes After Antiviral Treatment of Chronic Hepatitis C
March 6, 2020 updated by: Yao Xie, Beijing Ditan Hospital
An Observational Cohort Study of Clinical Outcomes After Antiviral Treatment of Chronic Hepatitis C Patients
This study is a two-way, non-interventional long-term dynamic follow-up clinical observational cohort study.
In the Second Division of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, chronic hepatitis C patients who were treated with interferon combined with ribavirin (PR) antiviral therapy (PR treatment for 6 months or more) and / or direct acting antivirals (DAAs ), and the baseline, antiviral treatment and discontinuation follow-up data of patients before antiviral treatment were collected, and follow-up observations of patients were carried out for every 3-6 months.
The clinical data such as clinical biochemistry, HCV RNA and serological indicators (anti-HCV), AFP, and liver imaging (liver ultrasound) were collected during the study period.
The virological response and clinical outcomes of chronic hepatitis C antiviral therapy were observed for at least 144 weeks.
The incidence of liver cancer and decompensated liver cirrhosis after discontinuation of the drug was the main evaluation index.
The aim is to explore long-term virological response and clinical outcomes, and elucidate its influencing factors.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This study is a two-way, non-interventional long-term dynamic follow-up clinical observational cohort study.
Enrolled in the Second Division of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, via interferon combined with ribavirin (PR) antiviral therapy (PR treatment for 6 months or more) and / or direct acting antivirals (DAAs ) For patients with chronic hepatitis C treated, collect baseline, antiviral treatment and discontinuation follow-up data of patients before antiviral treatment, and follow-up observations of patients enrolled every 3-6 months.
Collect clinical data such as clinical biochemistry, HCV RNA and serological indicators (anti-HCV), AFP, and liver imaging (liver ultrasound) during the study period.
The virological response and clinical outcomes of chronic hepatitis C antiviral therapy were observed for at least 144 weeks.
The incidence of liver cancer and decompensated liver cirrhosis after discontinuation of the drug was the main evaluation index.
The aim is to explore long-term virological response and clinical outcomes, and elucidate its 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
- Department of Hepatology Division 2, Beijing Ditan Hospital
-
Contact:
- Yao Xie, Doctor
- Phone Number: 2489 8610-84322200
- Email: xieyao00120184@sina.com
-
Contact:
- Minghui Li, phD
- Phone Number: +86 10-84322284
- Email: wuhm2000@sina.com
-
-
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
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with chronic hepatitis C treated with interferon combined with ribavirin (PR) antiviral therapy (PR therapy for 6 months or more) and / or direct antiviral drugs (DAAs).
All patients with chronic hepatitis C met the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis C (2015).
Description
Inclusion Criteria:
- Ages 18 to 75;
- Unlimited gender;
- Patients with chronic hepatitis C treated with interferon combined with ribavirin (PR) antiviral therapy (PR therapy for 6 months or more) and / or direct antiviral drugs (DAAs). All patients with chronic hepatitis C met the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis C (2015)
- No hormones and / or immunosuppressants and other hepatoprotective drugs;
- Sign a written informed consent.
Exclusion Criteria:
- Combined with other hepatitis virus (HBV, HDV) infections;
- Immune liver disease;
- HIV infection;
- long-term alcohol and / or other liver damage drugs;
- mental illness;
- Evidence of liver tumor (liver cancer or AFP> 100 ng / ml);
- Decompensated cirrhosis;
- Those who have serious heart, brain, lung, kidney and other system diseases that cannot participate in long-term follow-up;
- There are hormones and / or immunosuppressants and other hepatoprotective drugs.
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
interferon combined with ribavirin (PR) antiviral therapy
Patients with chronic hepatitis C treated with interferon combined with ribavirin (PR) antiviral therapy (PR therapy greater than or equal to 6 months)
|
Patients with chronic hepatitis C treated with interferon combined with ribavirin (PR) antiviral therapy (PR therapy greater than or equal to 6 months)
|
direct antiviral drugs (DAAs)
Patients with chronic hepatitis C treated with direct antiviral drugs (DAAs)
|
Patients with chronic hepatitis C treated with direct antiviral drugs (DAAs)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of liver cancer
Time Frame: 144 weeks after withdrawal
|
Incidence of liver cancer after chronic hepatitis C antiviral treatment
|
144 weeks after withdrawal
|
Incidence of decompensated cirrhosis
Time Frame: 144 weeks after withdrawal
|
Incidence of decompensated cirrhosis after chronic hepatitis C antiviral treatment
|
144 weeks after withdrawal
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of sustained virological response or relapse
Time Frame: 144 weeks after withdrawal
|
Rate of sustained virological response or relapse after antiviral treatment of chronic hepatitis C
|
144 weeks after withdrawal
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
September 1, 2019
Primary Completion (Anticipated)
September 1, 2020
Study Completion (Anticipated)
September 1, 2020
Study Registration Dates
First Submitted
March 5, 2020
First Submitted That Met QC Criteria
March 6, 2020
First Posted (Actual)
March 10, 2020
Study Record Updates
Last Update Posted (Actual)
March 10, 2020
Last Update Submitted That Met QC Criteria
March 6, 2020
Last Verified
March 1, 2020
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
- Antimetabolites
- Antineoplastic Agents
- Interferons
- Ribavirin
- Antiviral Agents
Other Study ID Numbers
- DTXY023
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.
Clinical Trials on Chronic Hepatitis C
-
Sohag UniversityRecruiting
-
Tripep ABInovio PharmaceuticalsUnknownChronic Hepatitis C Virus InfectionSweden
-
AbbVieCompletedHepatitis C Virus | Chronic Hepatitis C Virus
-
AbbVie (prior sponsor, Abbott)CompletedHepatitis C | Chronic Hepatitis C Infection | HCV | Hepatitis C Genotype 1United States
-
Hospices Civils de LyonCompleted
-
Humanity and Health Research CentreBeijing 302 Hospital; Nanfang Hospital of Southern Medical University; Yamanashi...Recruiting
-
Hadassah Medical OrganizationXTL BiopharmaceuticalsWithdrawnChronic Hepatitis C Virus InfectionIsrael
-
Hadassah Medical OrganizationUnknownChronic Hepatitis C Virus InfectionIsrael
-
AbbVie (prior sponsor, Abbott)CompletedHepatitis C | Chronic Hepatitis C Infection | HCV | Hepatitis C Genotype 1United States, Puerto Rico
Clinical Trials on interferon combined with ribavirin (PR) antiviral therapy
-
Dayanand Medical College and HospitalCompleted
-
Tel-Aviv Sourasky Medical CenterUnknown
-
Kaohsiung Medical University Chung-Ho Memorial...Completed
-
National Institute of Allergy and Infectious Diseases...CompletedHIV Infections | Hepatitis CUnited States
-
Minneapolis Veterans Affairs Medical CenterUS Department of Veterans Affairs; Kadmon Corporation, LLC; InterMune; San Diego... and other collaboratorsCompletedChronic Hepatitis C
-
Kaohsiung Medical University Chung-Ho Memorial...Completed
-
Aga Khan UniversityGetz PharmaCompletedHepatitis C | Chronic Disease | TreatmentPakistan
-
UPECLIN HC FM Botucatu UnespCompletedHepatitis, Viral, Non-A, Non-B, Parenterally-TransmittedBrazil
-
National Institutes of Health Clinical Center (CC)CompletedHIV Infection | Hepatitis C InfectionUnited States
-
Eastern Cooperative Oncology GroupNational Cancer Institute (NCI)Completed