Hepatitis CPhase 4NCT05467826
Efficacy and Safety of SOF/VEL + RBV and SOF/VEL/VOX for 12 Weeks in HCV Subjects With GT3b and Compensated Cirrhosis
A Phase 4 study testing Sofosbuvir/Velpatasvir + Ribavirin and Sofosbuvir/Velpatasvir/Voxilaprevir in people with Hepatitis C and Cirrhosis, run by Peking University People's Hospital.
Trial summary
Direct-acting antiviral agents (DAAs) targeting HCV have revolutionized the treatment of HCV. The efficacy of DAA-based therapy can depend on patient-related factors such as treatment experience, cirrhosis, but also on viral genotype. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Cirrhosis
- What is being tested?
- Sofosbuvir/Velpatasvir + Ribavirin and Sofosbuvir/Velpatasvir/Voxilaprevir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 31 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent
- Male or female, age ≥18 years
- Body mass index (BMI) between 18.0-35.0kg/m2 and bodyweight ≥ 40 kg
- Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
- Anti-HCV positive at screening
- HCV RNA 104 IU/mL at screening by the Central Laboratory
Show all 17Show fewer
- HCV genotype 3b assessed at screening by the Central Laboratory
- DAA treatment naïve defined as having never been exposed to approved or experimental HCV-specific direct-acting antiviral agents. Pegylated interferon/interferon based prior treatment is allowed.
- Cirrhosis Determination: cirrhosis is defined as any one of the following:
- Liver biopsy showing cirrhosis (e.g., Metavir score = 4 or Ishak score ≥5) in 24 months before screening, or
- Fibroscan® with a result of >12.5 kPa in 6 months before screening
- The lab test at screening should meet all the criterion below: a) ALT ≤ 10 the upper limit of normal (ULN); b) AST ≤ 10 ULN; c) Total bilirubin ≤ 2 ULN; d) Platelets ≥ 60,000/L; e) Neutrophile ≥ 1,500/L; f) HbA1c ≤ 8.5%; g) Creatinine clearance (CLcr) ≥ 60 mL /min as calculated by the Cockcroft-Gault equation; h) Hemoglobin ≥ 11 g/dL for female subjects; ≥ 12 g/dL for male subjects; i) Albumin ≥ 3 g/dL; j) INR ≤ 1.7 x ULN; k) AFP <100ng/mL；if 20ng/mL≤AFP≤100ng/mL，HCC should be exclude by liver ultrasound
- Females of childbearing potential must have a negative serum pregnancy test at screening
- Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
- Male subjects must agree to avoid donating sperm in 6 months after the last dose of drug
- Subject must be of generally good health, with the exception of chronic HCV infection, as determined by the Investigator
- Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments
Who cannot join
- Decompensated cirrhosis, including but not limited to: prior or current ascites, variceal hemorrhage and/or hepatic encephalopathy; prior or current Child-Pugh B or C
- HBsAg posititve at screening
- Anti-HIV positive at screening
- Alcohol abuse
- Contraindication of ribavirin, including but not limited to hemoglobinapathy
- Pregnant or nursing female or male with pregnant female partner
Show all 10Show fewer
- Use of any prohibited concomitant medications as described in Section before screening
- Known hypersensitivity to SOF, VEL, RBV or formulation excipients
- Subjects who has any of the following history: a) Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis); b) Solid organ transplantation; c) Significant pulmonary disease, significant cardiac disease or porphyria; d) Pancreatitis; e) Autoimmune diseases (e.g., systemic lupus erythematosus, sarcoidosis, psoriasis); f) Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years; g) Malignancy within the 5 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible; h) Significant drug allergy (such as anaphylaxis or hepatotoxicity).
- Assessed as ineligible by investigators
Trial locations and contacts
No sites are listed yet.
Huiying Rao, Dr. contact
About this study
Official title: Efficacy and Safety of Sofosbuvir/Velpatasvir Plus Ribavirin for 12 Weeks or Sofosbuvir/Velpatasvir/Voxilaprevir for 12 Weeks in DAA Treatment Naïve HCV Subjects With GT3b, Compensated Cirrhosis in China
Direct-acting antiviral agents (DAAs) targeting HCV have revolutionized the treatment of HCV. The efficacy of DAA-based therapy can depend on patient-related factors such as treatment experience, cirrhosis, but also on viral genotype. The high prevalence of genotype 3, which is considered difficult to cure, remains a challenge because many oral DAAs are less effective for this genotype, particularly subtype 3b than for others. Current guidance generally recommends sofosbuvir (SOF)/velpatasvir (VEL) ± ribavirin (RBV), glecaprevir/pibrentasvir and SOF/VEL/voxilaprevir (VOX) as first-line therapy for genotype 3, and an interferon-based regimen - SOF plus pegylated interferon and ribavirin is still recommended as an alternative treatment option. These recommendations are based on clinical data generated in regions where genotype 3a predominates. Our recent study indicated that sofosbuvir plus ribavirin for 24 weeks in subjects with HCV genotype 3 infection resulted in high rates of SVR. However, the SVR12 rate among subjects with genotype 3b was lower than that observed in subjects with genotype 3a infection, particularly among treatment-experienced subjects with cirrhosis.
Our study aimed to investigate the efficacy and safety of SOF/VEL plus RBV for 12 weeks or SOF/VEL/VOX for 12 weeks in DAAs treatment naïve HCV subjects with GT3b, compensated cirrhosis in China.
Read the detailed description
Chronic hepatitis C virus (HCV) infection, which may lead to cirrhosis and hepatocellular carcinoma, is a major cause of chronic liver disease worldwide. Genotype 3 is the second most common genotype globally, accounting for approximately 18% of all adult HCV infections. Subjects with HCV genotype 3 infection, particularly genotype 3b, have a greater risk of developing hepatic steatosis, more rapid progression of hepatic fibrosis and cirrhosis, and hepatocellular carcinoma. Although there is only a small percentage of HCV subjects with genotype 3 in East Asia (5.4%) and China (8.7%), genotype 3b represents more than 50% of genotype 3 subjects in China,compared to most other regions of the world where genotype 3a predominates. In certain provinces of China, such as Yunnan Guizhou, and Chongqing, genotype 3b is the predominant HCV subtype among genotype 3 subjects.
Direct-acting antiviral agents (DAAs) targeting HCV have revolutionized the treatment of HCV. The efficacy of DAA-based therapy can depend on patient-related factors such as treatment experience, cirrhosis, but also on viral genotype. The high prevalence of genotype 3, which is considered difficult to cure, remains a challenge because many oral DAAs are less effective for this genotype, particularly subtype 3b than for others. Current guidance generally recommends sofosbuvir (SOF)/velpatasvir (VEL) ± ribavirin (RBV), glecaprevir/pibrentasvir and SOF/VEL/voxilaprevir (VOX) as first-line therapy for genotype 3, and an interferon-based regimen - SOF plus pegylated interferon and ribavirin is still recommended as an alternative treatment option. These recommendations are based on clinical data generated in regions where genotype 3a predominates. Our recent study indicated that sofosbuvir plus ribavirin for 24 weeks in subjects with HCV genotype 3 infection resulted in high rates of SVR. However, the SVR12 rate among subjects with genotype 3b was lower than that observed in subjects with genotype 3a infection, particularly among treatment-experienced subjects with cirrhosis.
Our study aimed to investigate the efficacy and safety of SOF/VEL plus RBV for 12 weeks or SOF/VEL/VOX for 12 weeks in DAAs treatment naïve HCV subjects with GT3b, compensated cirrhosis in China.
- Conditions
- Hepatitis C, Cirrhosis
- Being tested
- Sofosbuvir/Velpatasvir + Ribavirin, Sofosbuvir/Velpatasvir/Voxilaprevir
- Medical subject headings
- Hepatitis C, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbuvir/Velpatasvir + RibavirinDrug
Also called Epclusa
Sofosbuvir 400mg/velpatasvir 100mg + ribavirin 1000mg/1200mg for 12 weeks
Sofosbuvir/Velpatasvir/VoxilaprevirDrug
Also called Vosevi
Sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Sofosbuvir 400mg/velpatasvir 100mg + ribavirin 1000mg/1200mg for 12 weeks Receives: Drug: Sofosbuvir/Velpatasvir + Ribavirin |
| Arm 2 | Experimental | Sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg for 12 weeks Receives: Drug: Sofosbuvir/Velpatasvir/Voxilaprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants with SVR12
To evaluate the efficacy of treatment with SOF/VEL plus RBV for 12 weeks or SOF/VEL/VOX for 12 weeks in DAA treatment naïve HCV participants with GT3b, participants initiated on treatment will be assessed for viral load response at 12 weeks post treatment (SVR12). We use the proportion of participants with SVR12 as primary outcome measure.
Measured: 12 weeks post treatment.
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of Participants With treatment-related adverse events as assessed by CTCAE v4.0- SOF/VEL plus RBV vs. SOF/VEL/VOX.
Measured: Treatment start date through treatment completion (up to 24 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start1 Sep 2022 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huiying Rao, Peking University People's Hospital
- Investigators
- Huiying Rao, Dr., Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467826
- Sponsor's protocol ID
- PKU-HCV-3B
- Status last verified
- Jul 2022
- First submitted
- 18 Jul 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang R, Ji F, Jiang Y, Li S, Su M, Zhong Y, Zu H, Ding Y, Kong X, Shang J, Wei L, Rao H. Sofosbuvir/Velpatasvir/Voxilaprevir Versus Sofosbuvir/Velpatasvir Plus Ribavirin in Patients With Hepatitis C Virus Genotype 3b and Compensated Cirrhosis: A Multicentre Randomized Controlled Trial. J Med Virol. 2025 Nov;97(11):e70709. doi: 10.1002/jmv.70709.
PubMed 41255102
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sofosbuvir/Velpatasvir Plus Ribavirin for 12 Weeks or Sofosbuvir/Velpatasvir/Voxilaprevir for 12 Weeks in DAA Treatment Naïve HCV Subjects With GT3b, Compensated Cirrhosis in China
- ClinicalTrials.gov ID
- NCT05467826
- Acronym / sponsor ID
- PKU-HCV-3B
- Conditions
- Hepatitis C, Cirrhosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Jul 2022 (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.
Direct-acting antiviral agents (DAAs) targeting HCV have revolutionized the treatment of HCV. The efficacy of DAA-based therapy can depend on patient-related factors such as treatment experience, cirrhosis, but also on viral genotype. The high prevalence of genotype 3, which is considered difficult to cure, remains a challenge because many oral DAAs are less effective for this genotype, particularly subtype 3b than for others. Current guidance generally recommends sofosbuvir (SOF)/velpatasvir (VEL) ± ribavirin (RBV), glecaprevir/pibrentasvir and SOF/VEL/voxilaprevir (VOX) as first-line therapy for genotype 3, and an interferon-based regimen - SOF plus pegylated interferon and ribavirin is still recommended as an alternative treatment option. These recommendations are based on clinical data generated in regions where genotype 3a predominates. Our recent study indicated that sofosbuvir plus ribavirin for 24 weeks in subjects with HCV genotype 3 infection resulted in high rates of SVR. However, the SVR12 rate among subjects with genotype 3b was lower than that observed in subjects with genotype 3a infection, particularly among treatment-experienced subjects with cirrhosis.
Our study aimed to investigate the efficacy and safety of SOF/VEL plus RBV for 12 weeks or SOF/VEL/VOX for 12 weeks in DAAs treatment naïve HCV subjects with GT3b, compensated cirrhosis in China.
Detailed description
Chronic hepatitis C virus (HCV) infection, which may lead to cirrhosis and hepatocellular carcinoma, is a major cause of chronic liver disease worldwide. Genotype 3 is the second most common genotype globally, accounting for approximately 18% of all adult HCV infections. Subjects with HCV genotype 3 infection, particularly genotype 3b, have a greater risk of developing hepatic steatosis, more rapid progression of hepatic fibrosis and cirrhosis, and hepatocellular carcinoma. Although there is only a small percentage of HCV subjects with genotype 3 in East Asia (5.4%) and China (8.7%), genotype 3b represents more than 50% of genotype 3 subjects in China,compared to most other regions of the world where genotype 3a predominates. In certain provinces of China, such as Yunnan Guizhou, and Chongqing, genotype 3b is the predominant HCV subtype among genotype 3 subjects.
Direct-acting antiviral agents (DAAs) targeting HCV have revolutionized the treatment of HCV. The efficacy of DAA-based therapy can depend on patient-related factors such as treatment experience, cirrhosis, but also on viral genotype. The high prevalence of genotype 3, which is considered difficult to cure, remains a challenge because many oral DAAs are less effective for this genotype, particularly subtype 3b than for others. Current guidance generally recommends sofosbuvir (SOF)/velpatasvir (VEL) ± ribavirin (RBV), glecaprevir/pibrentasvir and SOF/VEL/voxilaprevir (VOX) as first-line therapy for genotype 3, and an interferon-based regimen - SOF plus pegylated interferon and ribavirin is still recommended as an alternative treatment option. These recommendations are based on clinical data generated in regions where genotype 3a predominates. Our recent study indicated that sofosbuvir plus ribavirin for 24 weeks in subjects with HCV genotype 3 infection resulted in high rates of SVR. However, the SVR12 rate among subjects with genotype 3b was lower than that observed in subjects with genotype 3a infection, particularly among treatment-experienced subjects with cirrhosis.
Our study aimed to investigate the efficacy and safety of SOF/VEL plus RBV for 12 weeks or SOF/VEL/VOX for 12 weeks in DAAs treatment naïve HCV subjects with GT3b, compensated cirrhosis in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Sofosbuvir/Velpatasvir + RibavirinSofosbuvir 400mg/velpatasvir 100mg + ribavirin 1000mg/1200mg for 12 weeks |
| Arm 2 | Experimental | Drug: Sofosbuvir/Velpatasvir/VoxilaprevirSofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Willing and able to provide written informed consent
- Male or female, age ≥18 years
- Body mass index (BMI) between 18.0-35.0kg/m2 and bodyweight ≥ 40 kg
- Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
- Anti-HCV positive at screening
Key exclusion criteria (10 listed)
- Decompensated cirrhosis, including but not limited to: prior or current ascites, variceal hemorrhage and/or hepatic encephalopathy; prior or current Child-Pugh B or C
- HBsAg posititve at screening
- Anti-HIV positive at screening
- Alcohol abuse
- Contraindication of ribavirin, including but not limited to hemoglobinapathy
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 + RibavirinAlso: EpclusaSofosbuvir 400mg/velpatasvir 100mg + ribavirin 1000mg/1200mg for 12 weeks | Drug | Arm 1 |
| Sofosbuvir/Velpatasvir/VoxilaprevirAlso: VoseviSofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg for 12 weeks | Drug | Arm 2 |
Primary outcome
The proportion of participants with SVR12
Time frame: 12 weeks post treatment.
To evaluate the efficacy of treatment with SOF/VEL plus RBV for 12 weeks or SOF/VEL/VOX for 12 weeks in DAA treatment naïve HCV participants with GT3b, participants initiated on treatment will be assessed for viral load response at 12 weeks post treatment (SVR12). We use the proportion of participants with SVR12 as primary outcome measure.
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Treatment start date through treatment completion (up to 24 weeks).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Derived from this study: PubMed 41255102Huang R, Ji F, Jiang Y, Li S, Su M, Zhong Y, Zu H, Ding Y, Kong X, Shang J, Wei L, Rao H. Sofosbuvir/Velpatasvir/Voxilaprevir Versus Sofosbuvir/Velpatasvir Plus Ribavirin in Patients With Hepatitis C Virus Genotype 3b and Compensated Cirrhosis: A Multicentre Randomized Controlled Trial. J Med Virol. 2025 Nov;97(11):e70709. doi: 10.1002/jmv.70709.
- Individual participant dataSharing planned: No
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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.
Huiying Rao, Dr. contact
Huiying Rao, Dr. principal investigator
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sofosbuvir/Velpatasvir + Ribavirin and Sofosbuvir/Velpatasvir/Voxilaprevir in people with Hepatitis C and Cirrhosis, run by Peking University People's Hospital.
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 17 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rui Huang, Dr. (+86 13601208547, strangehead@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 participants with SVR12 (time frame: 12 weeks post 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 NCT05467826, which also lists 1 linked publication.
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 21 Jul 2022.