Micro-elimination of Hepatitis C Virus Infection in Uremics

NCT03891550 | Unknown Phase 3 FDA Drug

• 1 other identifier: KMUHIRB-F(II)-20180057
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Keywords

HCV, micro-elimination, DAA

Outcome Measures

Primary Outcomes (1)

• The rate of HCV micro-elimination in the per-protocol (PP) HD centers

  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

  9 months

Secondary Outcomes (7)

• Rate of HCV micro-elimination in the full-analysis-set (FAS) HD centers

  9 months

• Rate of NoC-HD in the per-protocol (PP) HD centers

  9 months

• Rate of NoC-HD in the full-analysis-set (FAS) HD centers

  9 months

• Proportion of drug related adverse events

  6 months

• SVR12 rate in the FAS population

  6 months

Study Arms (1)

SOF/VEL

EXPERIMENTAL

sofosbuvir (SOF) 400 mg/Velpatasvir(VEL) 100 mg fixed-dosage combination once-daily for 12 weeks

Drug: Epclusa

Interventions

Epclusa DRUG

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

SOF/VEL

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

Location

Related Publications (2)

• Huang CF, Dai CY, Wang CW, Liang PC, Wei YJ, Tsai PC, Jang TY, Hsu PY, Jia-Jung Lee, Niu SW, Huang JC, Yeh ML, Huang CI, Hsieh MY, Lin YH, Chen SC, Chiu YW, Huang JF, Chang JM, Hwang SJ, Chuang WL, Yu ML; FORMOSA-LIKE investigators. Therapy as prevention toward HCV elimination in maintenance hemodialysis: a multi-center, prospective cohort study. Clin Kidney J. 2023 Jun 14;16(12):2429-2436. doi: 10.1093/ckj/sfad138. eCollection 2023 Dec.

  PMID: 38046041 DERIVED

• Yu ML, Huang CF, Wei YJ, Lin WY, Lin YH, Hsu PY, Hsu CT, Liu TW, Lee JJ, Niu SW, Huang JC, Hung TS, Yeh ML, Huang CI, Liang PC, Hsieh MY, Chen SC, Huang JF, Chang JM, Chiu YW, Dai CY, Hwang SJ, Chuang WL; FORMOSA-LIKE investigators. Establishment of an outreach, grouping healthcare system to achieve microelimination of HCV for uremic patients in haemodialysis centres (ERASE-C). Gut. 2021 Dec;70(12):2349-2358. doi: 10.1136/gutjnl-2020-323277. Epub 2020 Dec 10.

  PMID: 33303567 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

sofosbuvir-velpatasvir drug combination

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

Study Officials

• Ming-Lung Yu, MD.,PhD.

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: active, open labeled, single arm study

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 27, 2019
• Study Start: May 13, 2019
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: July 10, 2020

Record last verified: 2020-07

Locations

TW (1)