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Micro-elimination of Hepatitis C Virus Infection in Uremics

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891550
Recruitment Status : Active, not recruiting
First Posted : March 27, 2019
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary:
There is a huge gap between the clinical efficacy and community effectiveness in the treatment of chronic hepatitis C in Taiwan. HCV infection prevails in uremic patients with the prevalence of > 10 % in Taiwan.The current study will be executed in each participating hemodialysis centers by an outreach team of HCV treaters, treating all of the HCV-viremic uremia patients and HD staffs at the same time (group therapy) in each individual HD center (Erase-C campaign) with all oral directly-acting antivirals, to ensure the rates of diagnosis, accessibility, treatment and follow-up.The purpose of the study is to demonstrate a model of care using outreach HCV treaters by implementing the concept of "group therapy" with one-size-fit-all pangenotypic DAA regimen, 12 weeks of sofosbuvir/velpatasvir, in each individual hemodialysis center (Erase-C campaign) to achieve HCV micro-elimination.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Epclusa Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: active, open labeled, single arm study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Micro-elimination of Hepatitis C Virus Infection With Pan-genotypic DAA Regimen in Hepatitis C Highly Endemic and Contagious Community (ERASE-C)
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : April 15, 2024
Estimated Study Completion Date : April 15, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SOF/VEL
sofosbuvir (SOF) 400 mg/Velpatasvir(VEL) 100 mg fixed-dosage combination once-daily for 12 weeks
Drug: Epclusa
sofosbuvir (SOF) 400 mg/Velpatasvir(VEL) 100 mg fixed-dosage combination once-daily for 12 weeks for all HCV genotype patients with and without hepatic decompensation




Primary Outcome Measures :
  1. The rate of HCV micro-elimination in the per-protocol (PP) HD centers [ Time Frame: 9 months ]
    proportion of HD centers t-C campaign"hat achieve an 80% reduction of prevalence rate of HCV viremia in each individual HD center at post campaign week 24 among the HD centers that having ≥ 90% of HCV viremic patients participating the "Erase


Secondary Outcome Measures :
  1. Rate of HCV micro-elimination in the full-analysis-set (FAS) HD centers [ Time Frame: 9 months ]
    proportion of HD centers that achieve an 80% reduction of prevalence rate of HCV viremia in each individual HD center at post campaign week 24 among the HD centers that having ≥ one HCV viremic patients participating the "Erase-C campaign" and receiving ≥ one doe of any study medication.

  2. Rate of NoC-HD in the per-protocol (PP) HD centers [ Time Frame: 9 months ]
    proportion of HD centers with all patients of HCV viremia at baseline becoming HCV-RNA < LLOQ, at post campaign week 24 in HD centers that having all HCV viremic patients participating the "Erase-C campaign".

  3. Rate of NoC-HD in the full-analysis-set (FAS) HD centers [ Time Frame: 9 months ]
    proportion of HD centers with all patients of HCV viremia at baseline becoming HCV-RNA < LLOQ, at post campaign week 24 in HD centers that having ≥ one HCV viremic patients participating the "Erase-C campaign" and receiving ≥ one doe of any study medication.

  4. Proportion of drug related adverse events [ Time Frame: 6 months ]
    any adverse events, serious adverse events, discontinuations and laboratory abnormality during and 24 weeks after study medication in the full-analysis-set (FAS) population (subjects receiving ≥ 1 dose of any study medication).

  5. SVR12 rate in the FAS population [ Time Frame: 6 months ]
    proportion of patients with HCV-RNA < LLOQ, at post treatment week 12 in FAS population

  6. SVR rate in the modified full-analysis-set (mFAS) population [ Time Frame: 6 months ]
    proportion of patients with HCV-RNA < LLOQ at posttreatment week 12 in mFAS population (subjects receiving ≥1 dose of any study medication and HCV RNA data available at posttreatment week 12 and excluding non-virological failures)

  7. The annual incidence rate of new HCV infection [ Time Frame: 60 months ]
    new infection of HCV among staffs/patients who are HCV non-viremic at pre-screening of the study, or reinfection characterized by viral sequencing, among HCV staffs/patients who achieve an SVR12 after SOF/VEL treatment, during 5-year follow-up.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Medical staffs and patients on HD, with age 20 years or more at the time of screening, agree to participate the study and provide informed consent.
  • A negative serum pregnancy test is required for female subjects (unless permanently sterile or greater than two years post-menopausal)
  • Subjects and their partners are considered childbearing potential must agree to use acceptable contraceptive method during treatment till SVR12.
  • Ability to participate and willingness to give written informed consent and to comply with the study restrictions.

Exclusion Criteria:

Medical staffs or uremic patients who are seropositive for HCV RNA and have contraindication to or unwilling to receive SOF/VEL, or who failed to prior IFN-free direct antiviral agents (DAA) regimens


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): NCT03891550


Locations
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Taiwan
Kaohsiung Medical University Hospital
Kaohsiung, Taiwan, 807
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
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Principal Investigator: Ming-Lung Yu, MD.,PhD. Kaohsiung Medical University
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Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT03891550    
Other Study ID Numbers: KMUHIRB-F(II)-20180057
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
HCV, micro-elimination, DAA
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Sofosbuvir-velpatasvir drug combination
Antiviral Agents
Anti-Infective Agents