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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04301882
Recruitment Status : Recruiting
First Posted : March 10, 2020
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Yao Xie, Beijing Ditan Hospital

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.

Condition or disease Intervention/treatment
Chronic Hepatitis C Drug: interferon combined with ribavirin (PR) antiviral therapy Drug: direct antiviral drugs (DAAs)

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 144 Weeks
Official Title: An Observational Cohort Study of Clinical Outcomes After Antiviral Treatment of Chronic Hepatitis C Patients
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


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)
Drug: 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)

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




Primary Outcome Measures :
  1. Incidence of liver cancer [ Time Frame: 144 weeks after withdrawal ]
    Incidence of liver cancer after chronic hepatitis C antiviral treatment

  2. Incidence of decompensated cirrhosis [ Time Frame: 144 weeks after withdrawal ]
    Incidence of decompensated cirrhosis after chronic hepatitis C antiviral treatment


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04301882


Locations
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China, Beijing
Department of Hepatology Division 2, Beijing Ditan Hospital Recruiting
Beijing, Beijing, China, 100015
Contact: Yao Xie, Doctor    8610-84322200 ext 2489    xieyao00120184@sina.com   
Contact: Minghui Li, phD    +86 10-84322284    wuhm2000@sina.com   
Sponsors and Collaborators
Beijing Ditan Hospital
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Responsible Party: Yao Xie, Director of Hepatology Division 2, Beijing Ditan Hospital
ClinicalTrials.gov Identifier: NCT04301882    
Other Study ID Numbers: DTXY023
First Posted: March 10, 2020    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yao Xie, Beijing Ditan Hospital:
Chronic hepatitis C
Interferon
Ribavirin
Clinical outcome
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Antiviral Agents
Antineoplastic Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action