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Sofosbuvir/Velpatasvir/Voxilaprevir Salvage Therapy in Hepatitis C Patients Who Relapsed After DAA Treatment

29. april 2026 opdateret af: Huang Yan, Xiangya Hospital of Central South University

A Multicenter Study Evaluating the Efficacy and Safety of Sofosbuvir/Velpatasvir/Voxilaprevir in Chronic Hepatitis C Patients With Relapse After Direct-Acting Antiviral Therapy

This multicenter study evaluates the effectiveness and safety of a 12-week regimen of sofosbuvir/velpatasvir/voxilaprevir in patients with chronic hepatitis C who relapsed after prior direct-acting antiviral therapy. The study assesses the rate of sustained virologic response after treatment, along with changes in liver function and overall safety. It also explores whether clinical factors such as liver cirrhosis, viral genotype, and the use of ribavirin influence treatment outcomes, aiming to better define this regimen as a salvage therapy option.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Detaljeret beskrivelse

Despite the high cure rates achieved with direct-acting antiviral (DAA) therapies, a subset of patients with chronic hepatitis C virus (HCV) infection experience virologic relapse after treatment. Optimal retreatment strategies for these patients, particularly those with advanced liver disease or genotype 3 infection, remain an important clinical concern. This multicenter observational study was conducted across 24 academic centers in Hunan and Shanxi Provinces, China, to evaluate the real-world effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) as a salvage therapy. Adult patients with confirmed chronic HCV infection who relapsed following prior DAA therapy were enrolled and received a 12-week course of SOF/VEL/VOX. The use of ribavirin was permitted at the discretion of the treating physician. Virologic response was assessed by measuring HCV RNA levels during treatment and at 12 weeks after treatment completion to determine sustained virologic response (SVR12). Laboratory parameters, including liver function tests and hematologic indices, were monitored to evaluate treatment response and safety. Subgroup analyses were performed to explore the potential impact of baseline characteristics such as age, sex, liver cirrhosis status, viral genotype, and treatment regimen on treatment outcomes. Safety was assessed by recording adverse events throughout treatment and follow-up. This study aims to provide real-world evidence to support the use of SOF/VEL/VOX as an effective and well-tolerated retreatment option for patients with prior DAA failure, with particular attention to populations that are more difficult to treat.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

200

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Hunan
      • Changsha, Hunan, Kina, 410000
        • Xiangya Hospital of Central South University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients between the age of 18-75, who have confirmed chronic hepatitis C virus (HCV) infection and experienced virologic relapse after prior direct-acting antiviral (DAA) therapy, with detectable HCV RNA at enrollment, and who received a 12-week regimen of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) as salvage treatment.

Beskrivelse

Inclusion Criteria:

  1. Age ≥18 years at the time of enrollment
  2. Confirmed chronic hepatitis C virus (HCV) infection
  3. Documented virologic relapse after prior direct-acting antiviral (DAA) therapy
  4. Detectable HCV RNA at screening
  5. Received or planned to receive a 12-week regimen of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) as salvage therapy
  6. Willing and able to provide written informed consent

Exclusion Criteria:

  1. Pregnant or breastfeeding women
  2. Participation in another interventional clinical study during the study period

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Hepatitis C salvage therapy group

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sustained Virologic Response at 12 Weeks After Treatment (SVR12)
Tidsramme: 12 weeks after end of treatment
Proportion of participants with undetectable HCV RNA 12 weeks after completion of treatment.
12 weeks after end of treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
On-Treatment Virologic Response
Tidsramme: During treatment (Week 4 and Week 12)
Proportion of participants with undetectable HCV RNA during treatment.
During treatment (Week 4 and Week 12)
Normalization of Liver Enzymes
Tidsramme: Baseline to Week 12 of treatment
Proportion of participants achieving normalization of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels.
Baseline to Week 12 of treatment
Incidence of Adverse Events
Tidsramme: From treatment initiation to 12 weeks after end of treatment
Frequency and type of adverse events observed during treatment and follow-up.
From treatment initiation to 12 weeks after end of treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Xiangya Hospital of Central South University

Efterforskere

  • Studieleder: Huang Yan, Professor, Xiangya Hospital of Central South University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2022

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

22. april 2026

Først indsendt, der opfyldte QC-kriterier

29. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • xiangya HCV project

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hepatitis C-virus (HCV)

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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CROs in Belgium

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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