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

NCT04301882 | Unknown

• 1 other identifier: DTXY023
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Hepatitis C

Keywords

Chronic hepatitis C; Interferon; Ribavirin; Clinical outcome

Outcome Measures

Primary Outcomes (2)

• Incidence of liver cancer

  Incidence of liver cancer after chronic hepatitis C antiviral treatment

  144 weeks after withdrawal

• Incidence of decompensated cirrhosis

  Incidence of decompensated cirrhosis after chronic hepatitis C antiviral treatment

  144 weeks after withdrawal

Secondary Outcomes (1)

• Rate of sustained virological response or relapse

  144 weeks after withdrawal

Study Arms (2)

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)

Drug: interferon combined with ribavirin (PR) antiviral therapy

direct antiviral drugs (DAAs)

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

Drug: direct antiviral drugs (DAAs)

Interventions

interferon combined with ribavirin (PR) antiviral therapy DRUG

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

direct antiviral drugs (DAAs) DRUG

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

direct antiviral drugs (DAAs)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Ditan Hospital: lead

Study Sites (1)

Department of Hepatology Division 2, Beijing Ditan Hospital

Beijing, Beijing Municipality, 100015, China

RECRUITING

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 144 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Hepatology Division 2

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 10, 2020
• Study Start: September 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

CN (1)