HCV Reinfection in HD Patients Achieving SVR

NCT04732832 | Unknown

• 1 other identifier: 202012090RINC
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 7

Brief Summary

Among the hemodialysis units, the global incidence of HCV infection ranges from 1.2% to 2.9%. Data regarding the long-term risk of reinfection among hemodialysis patients achieving SVR are limited. To our best knowledge, only one study assessed the long-term negativity of serum HCV RNA in hemodialysis patients who achieved SVR after IFN-based therapies. With a median follow-up of 48 months following SVR, the life-time cumulative survival for HCV RNA negativity was 86% among the 121 participants who were on maintenance dialysis. Furthermore, the life-time cumulative survival for HCV RNA negativity was 95% among the 45 participants who underwent renal transplantation from HCV-negative donors. Because the literatures regarding the long-term follow-up of viral outcome, the patient numbers to be recruited are still limited, and all studies are focused on IFN-based treatment, we aim to assess the long-term risk of HCV reinfection in hemodialysis patients attaining SVR by IFN-based or IFN-free therapies.

Conditions

Hepatitis C Virus Infection; Hepatitis C Virus Infection, Response to Therapy of; Hemodialysis Complication

Keywords

Hepatitis C virus; Hemodialysis; Sustained virologic response; Reinfection

Outcome Measures

Primary Outcomes (1)

• Cumulative reinfection rate

  Time-dependent accumulative proportion of participants with evidence of resurgence of HCV viremia from the time point of viral clearance after antiviral therapy to the time point of last follow-up

  Through study completion, an average of 3 years

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hemodialysis patients who undergo antiviral therapy for hepatitis C virus infection and who achieve sustained virologic response

You may qualify if:

• Age old than 20 years old
• Patients receiving hemodialysis during interferon (IFN)-based or IFN-free antiviral therapy
• Patients achieving sustained virologic response (SVR), defined as undetectable serum HCV RNA at week 12 off-therapy

You may not qualify if:

• Poor access to sites for venipuncture

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (7)

National Taiwan University Hospital, Yun-Lin Branch

Douliu, 640, Taiwan

RECRUITING

China Medical University Hospital

Taichung, 40447, Taiwan

RECRUITING

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Taipei City Hospital, Ren-Ai Branch

Taipei, 10629, Taiwan

RECRUITING

Taipei Medical University Hospital

Taipei, 110, Taiwan

RECRUITING

Tri-Service General Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Hepatitis C; Reinfection

Condition Hierarchy (Ancestors)

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

Study Officials

• Chen-Hua Liu, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen-Hua Liu, MD

CONTACT

+886-223123456; jacque_liu@mail2000.com.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 1, 2021
• Study Start: February 1, 2021
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

TW (7)