Observational Cohort Study of Clinical Outcomes After Antiviral Therapy for Chronic Hepatitis C

NCT ID: NCT04071353

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-01

Study Completion Date

2020-08-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Intervention Type DRUG

Interferon combined with ribavirin antiviral therapy

ribavirin

Intervention Type DRUG

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

Intervention Type DRUG

DAAs antiviral treatment

Interventions

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Interferon

Interferon combined with ribavirin antiviral therapy

Intervention Type DRUG

ribavirin

Interferon combined with ribavirin antiviral therapy

Intervention Type DRUG

DAAs

DAAs antiviral treatment

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Ditan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yao Xie

Director of liver disease

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yao Xie, phD/MD

Role: STUDY_DIRECTOR

Beijing Ditan Hospital

Locations

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liver disease center, Beijing Ditan Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yao Xie, doctor

Role: CONTACT

8613501093293

Facility Contacts

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Yao Xie, phD/MD

Role: primary

8610-84322200 ext. 2489

Other Identifiers

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DTXY021

Identifier Type: -

Identifier Source: org_study_id

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