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

NCT04071353 | Unknown DMC

• 1 other identifier: DTXY021
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Chronic Hepatitis C

Keywords

chronic hepatitis C; Interferon; Ribavirin; Clinical outcome

Outcome Measures

Primary Outcomes (2)

• The incidence of liver cancer

  The incidence of liver cancer after anti-viral treatment of chronic hepatitis C

  up to 144 weeks

• The incidence of decompensated cirrhosis

  The incidence of decompensated cirrhosis after anti-viral treatment of chronic hepatitis C

  up to 144 weeks

Secondary Outcomes (3)

• Percentage of persistent virological response or relapse

  up to 144 weeks

• Related factors of liver cancer

  up to 144 weeks

• Related factors of decompensated cirrhosis

  up to 144 weeks

Study Arms (2)

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.

Drug: Interferon; Drug: ribavirin

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.

Drug: DAAs

Interventions

Interferon DRUG

Interferon combined with ribavirin antiviral therapy

Interferon combined with ribavirin group

ribavirin DRUG

Interferon combined with ribavirin antiviral therapy

Interferon combined with ribavirin group

DAAs DRUG

DAAs antiviral treatment

DAAs treatment group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• Co-infected with hepatitis B virus or human immunodeficiency virus
• Had an autoimmune disease, liver tumour, or severe cardiac disease.

Sponsors & Collaborators

• Beijing Ditan Hospital: lead

Study Sites (1)

liver disease center, Beijing Ditan Hospital

Beijing, Beijing Municipality, 100015, China

RECRUITING

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Interferons; 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)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Yao Xie, phD/MD

  Beijing Ditan Hospital

  STUDY DIRECTOR

Central Study Contacts

Yao Xie, doctor

CONTACT

8613501093293; xieyao00120184@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of liver disease

Study Record Dates

• First Submitted: August 18, 2019
• First Posted: August 28, 2019
• Study Start: August 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

CN (1)