Hepatitis C InfectionNCT05601518
Efficacy and Safety of Coblopasvir Hydrochloride Capsules Combined With Sofosbuvir Tablets for the Treatment of Chronic HCV Infection: A Prospective, Multi-center Real-world Study.
An observational study of Hepatitis C Infection, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
Chronic hepatitis C is a long-lasting infectious disease caused by hepatitis C virus (HCV). According to statistics by the World Health Organization (WHO), the global HCV prevalence is estimated at 2.8%, equating to approximately 185 million. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Infection
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 31 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: chronic hepatitis C infection (positive serum anti-HCV antibodies, detection of HCV RNA in serum)
Who may be able to join
- Chronic hepatitis C infection
- Age 18 years and over
- Patients who treated with coblopasvir hydrochloride capsules/sofosbuvir tablets;
Who cannot join
- Patients who are receiving other DAAs drugs at the same time;
- Subjects with poor compliance who are unable to complete treatment or follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Chronic hepatitis C is a long-lasting infectious disease caused by hepatitis C virus (HCV). According to statistics by the World Health Organization (WHO), the global HCV prevalence is estimated at 2.8%, equating to approximately 185 million. Chronic HCV infection can lead to chronic inflammatory necrosis and fibrosis in the liver, and in some patients can develop into hepatic cirrhosis and even hepatocellular carcinoma (HCC), endangering the health and life of patients.
The development of direct-acting antiviral agents (DAAs) since 2011 markedly improved antiviral efficacy and significantly shortened treatment cycle, making the drugs convenient for clinical use. Small molecule DAAs exert target-specific effects on proteins involved in the HCV life cycle and have been included in the treatment guidelines by leading associations for the study of liver diseases worldwide.
Read more
Treatment regimen for hepatitis C - coblopasvir hydrochloride capsules combined with sofosbuvir tablets:
Coblopasvir hydrochloride capsule is an NS5A inhibitor that inhibits the replication and assembly of HCV, and sofosbuvir tablet is a NS5B polymerase inhibitor. The primary efficacy results (sustained virologic response 12 weeks post-treatment, SVR12) were comparable between the phase II and III clinical studies: the overall SVR12 in subjects was 97%. The SVR12 after coblopasvir hydrochloride capsules combined with sofosbuvir tablets in genotype 3 infection with cirrhosis and genotype 3b infection with cirrhosis were superior to the results of sofosbuvir and velpatasvir tablets obtained in clinical studies in Asia (83% vs. 72%; 67% vs. 50%).
Coblopasvir hydrochloride capsule and sofosbuvir tablet were approved for marketing by National Medical Products Administration of China in Feb. 2020 and Mar. 2020, respectively. This study is designed to evaluate the safety and efficacy of coblopasvir hydrochloride capsules combined with sofosbuvir tablets in clinical practice after marketing.
- Conditions
- Hepatitis C Infection
- Keywords
- hepatitis C infection
- 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 |
|---|---|---|
| Single Group Assignment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virologic response (SVR)
The proportion of patients with undetectable levels is detected by highly sensitive HCV RNA assay (lower limit of detection < 15 IU/mL)
Measured: 24 weeks
Secondary outcomes (1)
Adverse events
Record AEs during the study (observe and record at any time).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start1 Nov 2022 (estimated)
- Primary completion31 Dec 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 (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C InfectionStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601518
- Sponsor's protocol ID
- 22408-0-03
- Status last verified
- Oct 2022
- First submitted
- 27 Oct 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
AASLD/IDSA HCV Guidance Panel. Hepatitis C guidance: AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus. Hepatology. 2015 Sep;62(3):932-54. doi: 10.1002/hep.27950. Epub 2015 Aug 4. No abstract available.
PubMed 26111063Wei L, Xie Q, Hou JL, Jia J, Li W, Xu M, Li J, Wu S, Cheng J, Jiang J, Wang G, Yang Y, Mou Z, Gao ZL, Gong G, Niu JQ, Hu P, Tang H, Lin F, Dou X, Li L, Zhang LL, Nan Y, Massetto B, Yang JC, Knox SJ, Kersey K, German P, Mo H, Jiang D, Brainard DM, Jiang J, Ning Q, Duan Z. Sofosbuvir plus ribavirin with or without peginterferon for the treatment of hepatitis C virus: Results from a phase 3b study in China. J Gastroenterol Hepatol. 2018 Jun;33(6):1168-1176. doi: 10.1111/jgh.14102. Epub 2018 Mar 25.
PubMed 29380415
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Coblopasvir Hydrochloride Capsules Combined With Sofosbuvir Tablets for the Treatment of Chronic HCV Infection: A Prospective, Multi-center Real-world Study.
- ClinicalTrials.gov ID
- NCT05601518
- Acronym / sponsor ID
- 22408-0-03
- Conditions
- Hepatitis C Infection
- Keywords
- hepatitis C infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 1 Nov 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.
Chronic hepatitis C is a long-lasting infectious disease caused by hepatitis C virus (HCV). According to statistics by the World Health Organization (WHO), the global HCV prevalence is estimated at 2.8%, equating to approximately 185 million. Chronic HCV infection can lead to chronic inflammatory necrosis and fibrosis in the liver, and in some patients can develop into hepatic cirrhosis and even hepatocellular carcinoma (HCC), endangering the health and life of patients.
The development of direct-acting antiviral agents (DAAs) since 2011 markedly improved antiviral efficacy and significantly shortened treatment cycle, making the drugs convenient for clinical use. Small molecule DAAs exert target-specific effects on proteins involved in the HCV life cycle and have been included in the treatment guidelines by leading associations for the study of liver diseases worldwide.
Treatment regimen for hepatitis C - coblopasvir hydrochloride capsules combined with sofosbuvir tablets:
Coblopasvir hydrochloride capsule is an NS5A inhibitor that inhibits the replication and assembly of HCV, and sofosbuvir tablet is a NS5B polymerase inhibitor. The primary efficacy results (sustained virologic response 12 weeks post-treatment, SVR12) were comparable between the phase II and III clinical studies: the overall SVR12 in subjects was 97%. The SVR12 after coblopasvir hydrochloride capsules combined with sofosbuvir tablets in genotype 3 infection with cirrhosis and genotype 3b infection with cirrhosis were superior to the results of sofosbuvir and velpatasvir tablets obtained in clinical studies in Asia (83% vs. 72%; 67% vs. 50%).
Coblopasvir hydrochloride capsule and sofosbuvir tablet were approved for marketing by National Medical Products Administration of China in Feb. 2020 and Mar. 2020, respectively. This study is designed to evaluate the safety and efficacy of coblopasvir hydrochloride capsules combined with sofosbuvir tablets in clinical practice after marketing.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Assignment | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- chronic hepatitis C infection (positive serum anti-HCV antibodies, detection of HCV RNA in serum)
Key inclusion criteria (3 listed)
- Chronic hepatitis C infection
- Age 18 years and over
- Patients who treated with coblopasvir hydrochloride capsules/sofosbuvir tablets;
Key exclusion criteria (2 listed)
- Patients who are receiving other DAAs drugs at the same time;
- Subjects with poor compliance who are unable to complete treatment or follow-up.
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 (SVR)
Time frame: 24 weeks
The proportion of patients with undetectable levels is detected by highly sensitive HCV RNA assay (lower limit of detection < 15 IU/mL)
1 secondary outcome
Adverse events
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Background: PubMed 26111063AASLD/IDSA HCV Guidance Panel. Hepatitis C guidance: AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus. Hepatology. 2015 Sep;62(3):932-54. doi: 10.1002/hep.27950. Epub 2015 Aug 4. No abstract available.
- Background: PubMed 29380415Wei L, Xie Q, Hou JL, Jia J, Li W, Xu M, Li J, Wu S, Cheng J, Jiang J, Wang G, Yang Y, Mou Z, Gao ZL, Gong G, Niu JQ, Hu P, Tang H, Lin F, Dou X, Li L, Zhang LL, Nan Y, Massetto B, Yang JC, Knox SJ, Kersey K, German P, Mo H, Jiang D, Brainard DM, Jiang J, Ning Q, Duan Z. Sofosbuvir plus ribavirin with or without peginterferon for the treatment of hepatitis C virus: Results from a phase 3b study in China. J Gastroenterol Hepatol. 2018 Jun;33(6):1168-1176. doi: 10.1111/jgh.14102. Epub 2018 Mar 25.
- 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.
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 Infection, run by Beijing Tsinghua Chang Gung Hospital 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 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: status not confirmed, as of the sponsor's last update on 1 Nov 2022. 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 Lai Wei, MD (+86-1056118881, weilai@mail.tsinghua.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained virologic response (SVR) (time frame: 24 weeks). 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 NCT05601518, 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 1 Nov 2022.