An Observational Cohort Study of Clinical Outcomes After Antiviral Treatment of Chronic Hepatitis C

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT04071353

Chronic Hepatitis C

UNKNOWN

The Predictive Value of On-treatment Virological Response for Sustained Virological Response in Chronic Hepatitis C

NCT01464008

Chronic Hepatitis C

COMPLETED

Study to Assess Clinical Outcomes in Chronic Hepatitis C Patients Previously Treated With Daclatasvir-Based Regimens

NCT03366610

Hepatitis C

COMPLETED

Follow up of IFN Vs DAAs HCV SVR (IFDACS Study)

NCT02578693

Chronic Hepatitis C Infection

COMPLETED

Pegylated Interferon Plus Ribavirin in Treating Older Patients With Chronic Hepatitis C

NCT00629824

Chronic Hepatitis C

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Hepatitis C

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

interferon combined with ribavirin (PR) antiviral therapy

Intervention Type DRUG

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)

direct antiviral drugs (DAAs)

Intervention Type DRUG

Patients with chronic hepatitis C treated with direct antiviral drugs (DAAs)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type DRUG

direct antiviral drugs (DAAs)

Patients with chronic hepatitis C treated with direct antiviral drugs (DAAs)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No