Hepatitis CNCT04948801
SOF/VEL±RBV: Efficacy and Safety in GT 3 and 6 HCV Patients
An observational study of Hepatitis C, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
150 GT3 or GT6 CHC patients with or without compensated cirrhosis will be recruited from five centers in China including G3a 50, G3b 50, G6 50 respectively. GT3a and GT6 CHC with or without compensated patients will be administered one pill of Epclusa each day for 12 weeks, and GT3b patients will be administered… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Epclusa (sofosbuvir and velpatasvir)
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2018to 30 Dec 2021
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The groups or cohorts will be selected from people who was diagnosed with hepatitis c at the hospital.
Who may be able to join
- HCV RNA ≥ 15 IU/Ml at Screening
- HCV genotype 3a ,3b and 6
- Hepatitis C without decompensated cirrhosis of the liver
Who cannot join
- Patients failed to previous NS5A-containing DAAs therapy
- Decompensated cirrhosis
- HCC
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Deparment of Infectious Diseases, the Second Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 020
Zhe-bin Wu, resident physician, 13751743264, wzbice1982@sohu.com
Zhe-bin Wu, resident physician
About this study
Official title: SOF/VEL±RBV: Real-World Efficacy and Safety in GT 3 and 6 HCV Patients in China
150 GT3 or GT6 CHC patients with or without compensated cirrhosis will be recruited from five centers in China including G3a 50, G3b 50, G6 50 respectively. GT3a and GT6 CHC with or without compensated patients will be administered one pill of Epclusa each day for 12 weeks, and GT3b patients will be administered Epclusa each plus Ribavirin for 12 weeks.
Read the detailed description
This is a Prospective, observational, multi-center, real-world study to investigate real world effectiveness and safety of SOF/VEL±RBV in Chinese patients infected by HCV GT-3 and 6. 150 GT3 or GT6 CHC patients with or without compensated cirrhosis will be recruited from five centers in China including G3a 50, G3b 50, G6 50 respectively. GT3a and GT6 CHC with or without compensated cirrhosis will be administered one pill of Epclusa each day for 12 weeks, and GT3b patients will be administered one pill of Epclusa each plus Ribavirin for 12 weeks.Demographic, clinical, adverse event and virological data were be collected throughout treatment and post-treatment follow-up.
- Conditions
- Hepatitis C
- Being tested
- Epclusa (sofosbuvir and velpatasvir)
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epclusa (sofosbuvir and velpatasvir)Drug
Epclusa (sofosbuvir and velpatasvir) is a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.
| Study group | Role | What they receive |
|---|---|---|
| genotype 3a HCV | genotype 3a hepatitis C Receives: Drug: Epclusa (sofosbuvir and velpatasvir) | |
| genotype 6 HCV | genotype 6 hepatitis C Receives: Drug: Epclusa (sofosbuvir and velpatasvir) | |
| genotype 3b HCV | genotype 3b hepatitis C Receives: Drug: Epclusa (sofosbuvir and velpatasvir) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVR12
HCV RNA <LLOQ at Week 12 after cessation of treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start8 Dec 2018
- Primary completion1 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhe-bin Wu, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948801
- Sponsor's protocol ID
- [2018]02-417-01
- Status last verified
- Jul 2021
- First submitted
- 16 Mar 2021
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOF/VEL±RBV: Real-World Efficacy and Safety in GT 3 and 6 HCV Patients in China
- ClinicalTrials.gov ID
- NCT04948801
- Acronym / sponsor ID
- [2018]02-417-01
- Conditions
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 8 Dec 2018 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 2 Jul 2021 (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.
150 GT3 or GT6 CHC patients with or without compensated cirrhosis will be recruited from five centers in China including G3a 50, G3b 50, G6 50 respectively. GT3a and GT6 CHC with or without compensated patients will be administered one pill of Epclusa each day for 12 weeks, and GT3b patients will be administered Epclusa each plus Ribavirin for 12 weeks.
Detailed description
This is a Prospective, observational, multi-center, real-world study to investigate real world effectiveness and safety of SOF/VEL±RBV in Chinese patients infected by HCV GT-3 and 6. 150 GT3 or GT6 CHC patients with or without compensated cirrhosis will be recruited from five centers in China including G3a 50, G3b 50, G6 50 respectively. GT3a and GT6 CHC with or without compensated cirrhosis will be administered one pill of Epclusa each day for 12 weeks, and GT3b patients will be administered one pill of Epclusa each plus Ribavirin for 12 weeks.Demographic, clinical, adverse event and virological data were be collected throughout treatment and post-treatment follow-up.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| genotype 3a HCV | – | Drug: Epclusa (sofosbuvir and velpatasvir)genotype 3a hepatitis C |
| genotype 6 HCV | – | Drug: Epclusa (sofosbuvir and velpatasvir)genotype 6 hepatitis C |
| genotype 3b HCV | – | Drug: Epclusa (sofosbuvir and velpatasvir)genotype 3b hepatitis C |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The groups or cohorts will be selected from people who was diagnosed with hepatitis c at the hospital.
Key inclusion criteria (3 listed)
- HCV RNA ≥ 15 IU/Ml at Screening
- HCV genotype 3a ,3b and 6
- Hepatitis C without decompensated cirrhosis of the liver
Key exclusion criteria (4 listed)
- Patients failed to previous NS5A-containing DAAs therapy
- Decompensated cirrhosis
- HCC
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
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 |
|---|---|---|
| Epclusa (sofosbuvir and velpatasvir)Epclusa (sofosbuvir and velpatasvir) is a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection. | Drug | genotype 3a HCV, genotype 3b HCV, genotype 6 HCV |
Primary outcome
SVR12
Time frame: 12 weeks
HCV RNA <LLOQ at Week 12 after cessation of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- 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.
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, run by Third Affiliated Hospital, Sun Yat-Sen 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 3 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: status not confirmed, as of the sponsor's last update on 2 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhang Xiao hong, Professor (020-85253333 ext. 2372, 1716511502@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SVR12 (time frame: 12 weeks). 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 2 Jul 2021.