Hepatitis C Virus (HCV)NCT07565948
Sofosbuvir/Velpatasvir/Voxilaprevir Salvage Therapy in Hepatitis C Patients Who Relapsed After DAA Treatment
An observational study of Hepatitis C Virus (HCV), run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatitis C Virus (HCV)
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age ≥18 years at the time of enrollment
- Confirmed chronic hepatitis C virus (HCV) infection
- Documented virologic relapse after prior direct-acting antiviral (DAA) therapy
- Detectable HCV RNA at screening
- Received or planned to receive a 12-week regimen of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) as salvage therapy
- Willing and able to provide written informed consent
Who cannot join
- Pregnant or breastfeeding women
- Participation in another interventional clinical study during the study period
Trial locations and contacts
1 site in 1 country.
China1 site
Xiangya Hospital of Central South University
Changsha, Hunan, 410000
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Hepatitis C Virus (HCV)
- Keywords
- Hepatitis C Virus (HCV)
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hepatitis C salvage therapy group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virologic Response at 12 Weeks After Treatment (SVR12)
Proportion of participants with undetectable HCV RNA 12 weeks after completion of treatment.
Measured: 12 weeks after end of treatment
Secondary outcomes (3)
On-Treatment Virologic Response
Proportion of participants with undetectable HCV RNA during treatment.
Measured: During treatment (Week 4 and Week 12)
Normalization of Liver Enzymes
Proportion of participants achieving normalization of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels.
Measured: Baseline to Week 12 of treatment
Incidence of Adverse Events
Frequency and type of adverse events observed during treatment and follow-up.
Measured: From treatment initiation to 12 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start1 Jan 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C Virus (HCV)Studies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang Yan, Xiangya Hospital of Central South University
- Investigators
- Huang Yan, Professor, Study director, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565948
- Sponsor's protocol ID
- xiangya HCV project
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Papaluca T, Roberts SK, Strasser SI, Stuart KA, Farrell G, MacQuillan G, Dore GJ, Wade AJ, George J, Hazeldine S, O'Beirne J, Wigg A, Fisher L, McGarity B, Sawhney R, Sinclair M, Thomas J, Valiozis I, Weltman M, Wilson M, Woodward A, Ahlenstiel G, Haque M, Levy M, Prewett E, Sievert W, Sood S, Tse E, Valaydon Z, Bowden S, Douglas M, New K, O'Keefe J, Hellard M, Doyle J, Stoove M, Thompson AJ. Efficacy and Safety of Sofosbuvir/Velpatasvir/Voxilaprevir for Hepatitis C Virus (HCV) NS5A-Inhibitor Experienced Patients With Difficult to Cure Characteristics. Clin Infect Dis. 2021 Nov 2;73(9):e3288-e3295. doi: 10.1093/cid/ciaa1318.
PubMed 32887983Llaneras J, Riveiro-Barciela M, Lens S, Diago M, Cachero A, Garcia-Samaniego J, Conde I, Arencibia A, Arenas J, Gea F, Torras X, Luis Calleja J, Antonio Carrion J, Fernandez I, Maria Morillas R, Rosales JM, Carmona I, Fernandez-Rodriguez C, Hernandez-Guerra M, Llerena S, Bernal V, Turnes J, Gonzalez-Santiago JM, Montoliu S, Figueruela B, Badia E, Delgado M, Fernandez-Bermejo M, Inarrairaegui M, Pascasio JM, Esteban R, Marino Z, Buti M. Effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir in patients with chronic hepatitis C previously treated with DAAs. J Hepatol. 2019 Oct;71(4):666-672. doi: 10.1016/j.jhep.2019.06.002. Epub 2019 Jun 14.
PubMed 31203153
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study Evaluating the Efficacy and Safety of Sofosbuvir/Velpatasvir/Voxilaprevir in Chronic Hepatitis C Patients With Relapse After Direct-Acting Antiviral Therapy
- ClinicalTrials.gov ID
- NCT07565948
- Acronym / sponsor ID
- xiangya HCV project
- Conditions
- Hepatitis C Virus (HCV)
- Keywords
- Hepatitis C Virus (HCV)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatitis C salvage therapy group | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- Age ≥18 years at the time of enrollment
- Confirmed chronic hepatitis C virus (HCV) infection
- Documented virologic relapse after prior direct-acting antiviral (DAA) therapy
- Detectable HCV RNA at screening
- Received or planned to receive a 12-week regimen of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) as salvage therapy
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding women
- Participation in another interventional clinical study during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sustained Virologic Response at 12 Weeks After Treatment (SVR12)
Time frame: 12 weeks after end of treatment
Proportion of participants with undetectable HCV RNA 12 weeks after completion of treatment.
3 secondary outcomes
On-Treatment Virologic Response
Time frame: During treatment (Week 4 and Week 12)
Normalization of Liver Enzymes
Time frame: Baseline to Week 12 of treatment
Incidence of Adverse Events
Time frame: From treatment initiation to 12 weeks after end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Background: PubMed 32887983Papaluca T, Roberts SK, Strasser SI, Stuart KA, Farrell G, MacQuillan G, Dore GJ, Wade AJ, George J, Hazeldine S, O'Beirne J, Wigg A, Fisher L, McGarity B, Sawhney R, Sinclair M, Thomas J, Valiozis I, Weltman M, Wilson M, Woodward A, Ahlenstiel G, Haque M, Levy M, Prewett E, Sievert W, Sood S, Tse E, Valaydon Z, Bowden S, Douglas M, New K, O'Keefe J, Hellard M, Doyle J, Stoove M, Thompson AJ. Efficacy and Safety of Sofosbuvir/Velpatasvir/Voxilaprevir for Hepatitis C Virus (HCV) NS5A-Inhibitor Experienced Patients With Difficult to Cure Characteristics. Clin Infect Dis. 2021 Nov 2;73(9):e3288-e3295. doi: 10.1093/cid/ciaa1318.
- Background: PubMed 31203153Llaneras J, Riveiro-Barciela M, Lens S, Diago M, Cachero A, Garcia-Samaniego J, Conde I, Arencibia A, Arenas J, Gea F, Torras X, Luis Calleja J, Antonio Carrion J, Fernandez I, Maria Morillas R, Rosales JM, Carmona I, Fernandez-Rodriguez C, Hernandez-Guerra M, Llerena S, Bernal V, Turnes J, Gonzalez-Santiago JM, Montoliu S, Figueruela B, Badia E, Delgado M, Fernandez-Bermejo M, Inarrairaegui M, Pascasio JM, Esteban R, Marino Z, Buti M. Effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir in patients with chronic hepatitis C previously treated with DAAs. J Hepatol. 2019 Oct;71(4):666-672. doi: 10.1016/j.jhep.2019.06.002. Epub 2019 Jun 14.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huang Yan, Professor study director
Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C Virus (HCV), run by Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Virologic Response at 12 Weeks After Treatment (SVR12) (time frame: 12 weeks after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07565948, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.