NCT05092074

Brief Summary

The investigators aim to assess the effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) for 12 weeks in hepatitis C virus (HCV)-infected patients who fail to prior NS5A-containing DAA regimens and HCV genotype 1a and 3 patients who fail to prior non-NS5A-containing DAA regimen in Taiwan on a basis of a multicenter observational study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

15 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

1.2 years

First QC Date

October 3, 2021

Last Update Submit

October 25, 2021

Conditions

Hepatitis C Virus InfectionTreatment Side EffectsAdherence, TreatmentEffect of Drug

Keywords

Hepatitis C virusSofosbuvirVelpatasvirVoxilaprevir

Outcome Measures

Primary Outcomes (1)

  • Sustained virologic response (SVR)

    Number and percentage of participants who have undetectable serum level of HCV RNA at off-treatment week 12

    A total of 24 weeks after the initiation of treatment (drug treatment for 12 weeks and off-treatment follow-up for additional 12 weeks)

Interventions

Vosevi 400/100/100 Oral TabletDRUG

Sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX, Vosevi) 400/100/100 oral tablet: 1 table per os per day for 12 weeks

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic hepatitis C virus-infected patients who are aged 20 years or more and who are not responded to a prior course of NA5A-containing DAA regimen (all viral genotypes) or to a prior course of non-NS5A-containing DAA regimen (viral genotype 1a or 3). Patients should have compensated liver diseases, and should not take co-medications which are contraindicated for use in the presence of SOF/VEL/VOX.

You may qualify if:

  • Chronic hepatitis C virus (HCV) infection, defined as the presence of HCV RNA for ≥ 6 months
  • Age ≥ 20 years
  • Patients with any HCV genotype (genotype 1-6 or indeterminate genotype) who failed to NS5A-containing DAA regimen or patients with HCV genotype 1a or 3 who failed to non-NS5A-containing DAA regimen

You may not qualify if:

  • Decompensated cirrhosis
  • Patients who receive concomitant medications which are contraindicated for SOF/VEL/VOX, and who decline to stop or switch contraindicated concomitant medications
  • Patients who receive therapeutic vaccination or other investigational agents for HCV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

China Medical University Beigang Hospital

Beigang, Taiwan

RECRUITING

Changhua Christian Hospital

Changhua, Taiwan

RECRUITING

Ditmanson Medical Foundation Chiayi Christian Hospital

Chiayi City, Taiwan

RECRUITING

St. Martin De Porres Hospital

Chiayi City, Taiwan

RECRUITING

Yang Ming Hospital

Chiayi City, Taiwan

RECRUITING

Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Dalin, Taiwan

RECRUITING

National Taiwan University Hospital, Yun-Lin Branch

Douliu, Taiwan

RECRUITING

Chi-Mei Medical Center, Liouying

Liuying, Taiwan

RECRUITING

Fu Jen Catholic University Hospital

New Taipei City, Taiwan

RECRUITING

China Medical University Hospital

Taichung, Taiwan

RECRUITING

Chung Shan Medical University Hospital

Taichung, Taiwan

RECRUITING

Taichung Veterans General Hospital

Taichung, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

Taipei Medical University Hospital

Taipei, Taiwan

RECRUITING

Tri-Service General Hospital

Taipei, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1. 5 mL of whole blood to detect the HCV viral resistance profiles (NS3 and NS5A regions) in all participants before SOF/VEL/VOX treatment 2. 5 mL of whole blood to detect the HCV viral resistance profiles (NS3 and NS5A regions) in participants who fail to respond to SOF/VEL/VOX treatment after off-therapy 12 weeks of observation

MeSH Terms

Conditions

Hepatitis CTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHealth BehaviorBehavior

Study Officials

  • Chen-Hua Liu, MD

    National Taiwan University Hospital

    STUDY DIRECTOR

Central Study Contacts

Chen-Hua Liu, MD

CONTACT

+886-223123456jacque_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

October 3, 2021

First Posted

October 25, 2021

Study Start

October 1, 2021

Primary Completion

December 31, 2022

Study Completion

February 28, 2023

Last Updated

November 1, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(15)