Chronic Hepatitis CNCT06180590
The Efficacy of Vosevi in Treating DAA-experienced Patients
An observational study of Chronic Hepatitis C and Medication Reaction, run by The Third Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
Hepatitis C virus (HCV) infection remains a significant health problem in our country. The World Health Organization estimated that 71 million people worldwide had chronic HCV infection in 2015. And 399,000 people died from cirrhosis or primary hepatocellular carcinoma caused by HCV infection. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Chronic Hepatitis C, Medication Reaction
- What is being tested?
- Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2023to 28 Feb 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We enroll DAAs-experienced hepatitis C patients in The Third Affiliated Hospital of Guangzhou Medical University
Who may be able to join
- Age of 20-70 years.
- Accepted the standard direct antiviral agent before
- HCV-RNA still positive
- Patients are administrated with once-daily oral Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir: 400mg/100mg/100mg) or Sofosbuvir/Velpatasvir (400mg/100mg) combined with ribavirin（500mg）twice a day treatment for rescue therapy.
- The good compliance of patients.
Who cannot join
- Patients with antibodies against HIV, HBV, HDV, concretion or other forms of infectious disease.
- Evidence of hepatocellular carcinoma, decompensated liver disease, auto-immune hepatitis, or significant renal, cardiovascular, respiratory or neurological comorbidity.
- Concurrent treatment with glucocorticoids, cytotoxic drugs, nonsteroidal anti-inflammatory drugs, or immune modulators.
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Xingfei Pan, PhD, 13662517686, panxf0125@163.com
About this study
Official title: A Prospective Cohort Study: the Efficacy of Vosevi in Treating Direct Antiviral Agent Therapy Failure Patients
Hepatitis C virus (HCV) infection remains a significant health problem in our country. The World Health Organization estimated that 71 million people worldwide had chronic HCV infection in 2015. And 399,000 people died from cirrhosis or primary hepatocellular carcinoma caused by HCV infection. In 2006, the positive rate of HCV antibody in the population aged 1-59 was 0.43%. Therefore, it was estimated that there were about 5.6 million HCV infected people in the general population, and about 10 million cases of HCV infected people in high-risk groups and high incidence areas.
Universal genotype direct antiviral agent (DAA) is the preferred antiviral therapy for hepatitis C. Sofosbuvir/velpatasvir are direct antiviral agents for hepatitis C. The results of Asian clinical trials mainly in Chinese population showed that the sustained virologic response (SVR) rates of sofosbuvir/velpatasvir at 12 weeks in genotype 1a, 1b, 2, 3a, 3b and 6 were 100%, 100%, 100%, 95%, 76% and 99%, respectively. Limited data showed that the SVR rate of sofosbuvir/velpatasvir at 12 weeks was 96% in Chinese genotype 3b patients without cirrhosis and 50% in patients with cirrhosis.
Read more
After standard antiviral therapy for hepatitis C, there are still some patients who cannot obtain SVR, and these patients are defined as DAA-experienced patients. The guidelines recommend that Sofosbuvir/Velpatasvir combined with ribavirin be used as salvage therapy for patients with DAA-experienced failure. Vosevi is a new generation of antiviral therapy for hepatitis C, which contains three components, (Sofosbuvir, Velpatasvir and Voxilaprevir. It was a salvage treatment plan for DAAs-experienced patients which was recommended by the Chinese hepatitis C prevention and treatment guidelines in 2019. However, there are insufficient data on the proportion of SVR acquired in Vosevi treated DAAs-experienced patients in Asian populations and the effectivity of antiviral therapy between Vosevi and Sofosbuvir/Velpatasvir combined with ribavirin.
In the present study, the investigators enroll DAAs-experienced hepatitis C patients. The participants are randomly divided into two groups. Then the participants are treated with Vosevi or Sofosbuvir/Velpatasvir combined with ribavirin respectively. All enrolled participants are followed-up for 3 years. Objectives of the present study are as follows:
- To clarify the sustained virologic response rate after Vosevi therapy for DAAs-experienced patients.
- To clarify the safety and efficacy between the Vosevi therapy and the Sofosbuvir/Velpatasvir combined with ribavirin therapy.
- To clarify the changes of biochemistry indexes in DAAs-experienced patients after Vosevi therapy.
- To clarify the virological relapse rate at 12 weeks after Vosevi therapy. E. To clarify the rate of cirrhosis and liver cancer during the follow-up.
- Conditions
- Chronic Hepatitis C, Medication Reaction
- Being tested
- Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]
- Keywords
- Vosevi, Efficacy, DAAs-experienced, Sustained Viral Response
- Medical subject headings
- Hepatitis C, Chronic, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]Drug
Evaluate the efficacy of Vosevi in DAAs-experienced patients
| Study group | Role | What they receive |
|---|---|---|
| Vosevi Group | Patients are administrated with once-daily oral Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir: 400mg/100mg/100mg) Receives: Drug: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi] | |
| Sofosbuvir/Velpatasvir combined with ribavirin Group | Patients are administrated with once-daily oral Sofosbuvir/Velpatasvir (400mg/100mg) combined with ribavirin（500mg）twice a day Receives: Drug: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi] |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of sustained virologic response after antiviral therapy
Testing HCV-RNA in patients after antiviral therapy using Vosevi or Sofosbuvir/Velpatasvir combined with ribavirin
Measured: in one week after completed the antiviral therapy
Secondary outcomes (3)
The proportion of ALT normalization after antiviral therapy
Testing for ALT level in patients after antiviral therapy using Vosevi or Sofosbuvir/Velpatasvir combined with ribavirin
Measured: in one week after completed the antiviral therapy
The proportion of virologic relapse after antiviral therapy
Testing HCV-RNA in patients at 12 weeks during off-treatment
Measured: in 12 weeks after completed the antiviral therapy
The proportion of hepatitis C patients developed into cirrhosis or liver cancer during off-treatment
Testing in patients every half a year during off-treatment
Measured: Liver ultrasound every half a year after completed the antiviral therapy until the study ending
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start28 Feb 2023
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xingfei Pan, PhD, Study director, The Third Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180590
- Sponsor's protocol ID
- LCYJ-2023-005
- Status last verified
- Jun 2023
- First submitted
- 12 Dec 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study: the Efficacy of Vosevi in Treating Direct Antiviral Agent Therapy Failure Patients
- ClinicalTrials.gov ID
- NCT06180590
- Acronym / sponsor ID
- LCYJ-2023-005
- Conditions
- Chronic Hepatitis C, Medication Reaction
- Keywords
- Vosevi, Efficacy, DAAs-experienced, Sustained Viral Response
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Third Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 22 Dec 2023 (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.
Hepatitis C virus (HCV) infection remains a significant health problem in our country. The World Health Organization estimated that 71 million people worldwide had chronic HCV infection in 2015. And 399,000 people died from cirrhosis or primary hepatocellular carcinoma caused by HCV infection. In 2006, the positive rate of HCV antibody in the population aged 1-59 was 0.43%. Therefore, it was estimated that there were about 5.6 million HCV infected people in the general population, and about 10 million cases of HCV infected people in high-risk groups and high incidence areas.
Universal genotype direct antiviral agent (DAA) is the preferred antiviral therapy for hepatitis C. Sofosbuvir/velpatasvir are direct antiviral agents for hepatitis C. The results of Asian clinical trials mainly in Chinese population showed that the sustained virologic response (SVR) rates of sofosbuvir/velpatasvir at 12 weeks in genotype 1a, 1b, 2, 3a, 3b and 6 were 100%, 100%, 100%, 95%, 76% and 99%, respectively. Limited data showed that the SVR rate of sofosbuvir/velpatasvir at 12 weeks was 96% in Chinese genotype 3b patients without cirrhosis and 50% in patients with cirrhosis.
After standard antiviral therapy for hepatitis C, there are still some patients who cannot obtain SVR, and these patients are defined as DAA-experienced patients. The guidelines recommend that Sofosbuvir/Velpatasvir combined with ribavirin be used as salvage therapy for patients with DAA-experienced failure. Vosevi is a new generation of antiviral therapy for hepatitis C, which contains three components, (Sofosbuvir, Velpatasvir and Voxilaprevir. It was a salvage treatment plan for DAAs-experienced patients which was recommended by the Chinese hepatitis C prevention and treatment guidelines in 2019. However, there are insufficient data on the proportion of SVR acquired in Vosevi treated DAAs-experienced patients in Asian populations and the effectivity of antiviral therapy between Vosevi and Sofosbuvir/Velpatasvir combined with ribavirin.
In the present study, the investigators enroll DAAs-experienced hepatitis C patients. The participants are randomly divided into two groups. Then the participants are treated with Vosevi or Sofosbuvir/Velpatasvir combined with ribavirin respectively. All enrolled participants are followed-up for 3 years. Objectives of the present study are as follows:
- To clarify the sustained virologic response rate after Vosevi therapy for DAAs-experienced patients.
- To clarify the safety and efficacy between the Vosevi therapy and the Sofosbuvir/Velpatasvir combined with ribavirin therapy.
- To clarify the changes of biochemistry indexes in DAAs-experienced patients after Vosevi therapy.
- To clarify the virological relapse rate at 12 weeks after Vosevi therapy. E. To clarify the rate of cirrhosis and liver cancer during the follow-up.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vosevi Group | – | Drug: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]Patients are administrated with once-daily oral Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir: 400mg/100mg/100mg) |
| Sofosbuvir/Velpatasvir combined with ribavirin Group | – | Drug: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]Patients are administrated with once-daily oral Sofosbuvir/Velpatasvir (400mg/100mg) combined with ribavirin（500mg）twice a day |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We enroll DAAs-experienced hepatitis C patients in The Third Affiliated Hospital of Guangzhou Medical University
Key inclusion criteria (5 listed)
- Age of 20-70 years.
- Accepted the standard direct antiviral agent before
- HCV-RNA still positive
- Patients are administrated with once-daily oral Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir: 400mg/100mg/100mg) or Sofosbuvir/Velpatasvir (400mg/100mg) combined with ribavirin（500mg）twice a day treatment for rescue therapy.
- The good compliance of patients.
Key exclusion criteria (4 listed)
- Patients with antibodies against HIV, HBV, HDV, concretion or other forms of infectious disease.
- Evidence of hepatocellular carcinoma, decompensated liver disease, auto-immune hepatitis, or significant renal, cardiovascular, respiratory or neurological comorbidity.
- Concurrent treatment with glucocorticoids, cytotoxic drugs, nonsteroidal anti-inflammatory drugs, or immune modulators.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]Evaluate the efficacy of Vosevi in DAAs-experienced patients | Drug | Sofosbuvir/Velpatasvir combined with ribavirin Group, Vosevi Group |
Primary outcome
The proportion of sustained virologic response after antiviral therapy
Time frame: in one week after completed the antiviral therapy
Testing HCV-RNA in patients after antiviral therapy using Vosevi or Sofosbuvir/Velpatasvir combined with ribavirin
3 secondary outcomes
The proportion of ALT normalization after antiviral therapy
Time frame: in one week after completed the antiviral therapy
The proportion of virologic relapse after antiviral therapy
Time frame: in 12 weeks after completed the antiviral therapy
The proportion of hepatitis C patients developed into cirrhosis or liver cancer during off-treatment
Time frame: Liver ultrasound every half a year after completed the antiviral therapy until the study ending
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 13 Mar 2024.
Related trials for Chronic Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
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.
Xingfei Pan, PhD study director
The Third Affiliated Hospital of Guangzhou Medical 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 Chronic Hepatitis C and Medication Reaction, run by The Third Affiliated Hospital of Guangzhou Medical 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 13 Mar 2024. 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?
Contact Xingfei Pan, PhD (13662517686, panxf0125@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of sustained virologic response after antiviral therapy (time frame: in one week after completed the antiviral therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2024.