Viral Hepatitis CNCT07316842
SVR12 in Genotype 3 HCV (F0-F2) Treated With RDV + SOF
An observational study of Viral Hepatitis C, run by Center of target therapy at 1 site in Russia.
Trial summary
This study will follow a group of people with chronic hepatitis C infection of genotype 3 who have mild to moderate liver fibrosis (stages F0-F2, measured by a liver stiffness test). All participants will be receiving the antiviral drugs ravidasvir and sofosbuvir as part of their regular medical care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Viral Hepatitis C
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 17 Sep 2025to 2 Feb 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic hepatitis C virus infection genotype 3 with fibrosis stage F0-F2 were selected for this non-interventional study. These patients represent an important group with a high probability of successful therapy response and relatively low risk of complications, making them ideal candidates for studying the efficacy and safety of a short-term treatment regimen with ravidasvir and sofosbuvir. A similar patient population showed a high rate of sustained virological response (93.42%) in the EASE clinical trial (NCT05757700) with an 8-week therapy regimen. Despite the presence of significant data on treatment of chronic hepatitis C overall, detailed descriptions of disease epidemiology depending on virus genotype, fibrosis stage, and treatment efficacy in patients at early disease stages in real clinical practice are limited.
Who may be able to join
- Patient informed consent for the collection and use of data in scientific research.
- Diagnosed chronic hepatitis C (genotype 3).
- Fibrosis stage F0-F2 according to METAVIR, confirmed by liver biopsy or liver elastography (results of performed studies must be no older than 3 months at the start of antiviral therapy).
- Signed informed consent.
- Age ≥18 years.
- Antiviral therapy with ravidasvir and sofosbuvir initiated as part of routine clinical practice.
Who cannot join
- Significant concomitant liver diseases considered relevant by the investigator (hepatitis B, hemochromatosis, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, hepatocellular carcinoma).
- Presence of other active viral infections (e.g., hepatitis B, HIV).
- If the patient has received other antiviral treatment for hepatitis C within the last 6 months.
- Pregnancy or breastfeeding.
- Alcohol or drug dependence that may interfere with adherence to the treatment regimen.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Single-cohort, Observational Clinical Study Evaluating the Rate of Achieving SVR12 in Patients With Chronic Hepatitis C Genotype 3 With Fibrosis Stage F0-F2 Who Received Ravidasvir + Sofosbuvir Therapy.
This study will follow a group of people with chronic hepatitis C infection of genotype 3 who have mild to moderate liver fibrosis (stages F0-F2, measured by a liver stiffness test). All participants will be receiving the antiviral drugs ravidasvir and sofosbuvir as part of their regular medical care.
Only patients who start this treatment, meet the study's eligibility criteria, and give written consent for their medical data to be used in research will take part. They will be monitored during their routine clinic visits while receiving the two-drug therapy.
After 8 weeks of treatment, researchers will check how many patients have cleared the virus from their blood. Those who achieve this response will continue to be followed for another 4 and 12 weeks after treatment to see if the virus remains undetectable.
Read the detailed description
An observational, prospective, single-cohort study will be conducted in patients with chronic hepatitis C virus infection of genotype 3 and fibrosis stage F0-F2 according to the METAVIR score based on liver elastography data, who have initiated antiviral therapy with ravidasvir and sofosbuvir as part of routine clinical practice.
Patients who have initiated antiviral therapy with ravidasvir and sofosbuvir, meet the inclusion criteria, and have signed informed consent for the use of their data in scientific research will be enrolled in the study. Patients will be followed in the clinic in accordance with routine medical practice during the course of ravidasvir and sofosbuvir antiviral therapy.
After 8 weeks of therapy, the rate of viral eradication in peripheral blood will be determined. Patients who achieve a virological response will continue to be followed to assess the maintenance of virological response at 4 and 12 weeks after completion of antiviral therapy.
- Conditions
- Viral Hepatitis C
- Keywords
- Ravidasvir, Sofosbuvir
- Medical subject headings
- Hepatitis C
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the rate of achieving sustained virological response (SVR12)
Absence of detectable hepatitis C virus (HCV) RNA in a patient's blood 12 weeks after completing antiviral treatment
Measured: 20 weeks after enrollment to the study (8 weeks of antiviral treatment + 12 week of post-treatment follow up)
Secondary outcomes (3)
Evaluation of the rate of achieving aviremia 4 weeks after completion of antiviral therapy (SVR-4)
The absence of detectable hepatitis C virus (HCV) RNA in a patient's blood 4 weeks after completing antiviral treatment
Measured: 12 weeks after enrollment (8 weeks of antiviral treatment + 4 weeks of post-treatment follow up)
Assessment of the dynamics of viral load changes during treatment
The amount of hepatitis C virus RNA present in a milliliter of a patient's blood (IU/mL).
Measured: At Week 4 after enrollment (therapy initiation), at Week 8 after enrollment (end of antiviral treatment), at Week 12 and Week 20 after enrollment (post-treatment follow up).
Assessment of the safety and tolerability of therapy.
The frequency and nature of side effects associated with the combination of ravidasvir and sofosbuvir.
Measured: 20 weeks after enrollment (8 weeks of antiviral therapy and 12 weeks of post-treatment follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start17 Sep 2025
- Primary completion2 Feb 2026 (estimated)
- Study completion2 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center of target therapy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pavel Bogomolov, Prof., PhD, MD, Principal investigator, Center of target therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316842
- Sponsor's protocol ID
- CTT-004
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-cohort, Observational Clinical Study Evaluating the Rate of Achieving SVR12 in Patients With Chronic Hepatitis C Genotype 3 With Fibrosis Stage F0-F2 Who Received Ravidasvir + Sofosbuvir Therapy.
- ClinicalTrials.gov ID
- NCT07316842
- Acronym / sponsor ID
- CTT-004
- Conditions
- Viral Hepatitis C
- Keywords
- Ravidasvir, Sofosbuvir
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Center of target therapyUniversity, hospital or other
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- 2 Feb 2026 (estimated)
- Study completion
- 2 Feb 2026 (estimated)
- First posted
- 5 Jan 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 study will follow a group of people with chronic hepatitis C infection of genotype 3 who have mild to moderate liver fibrosis (stages F0-F2, measured by a liver stiffness test). All participants will be receiving the antiviral drugs ravidasvir and sofosbuvir as part of their regular medical care.
Only patients who start this treatment, meet the study's eligibility criteria, and give written consent for their medical data to be used in research will take part. They will be monitored during their routine clinic visits while receiving the two-drug therapy.
After 8 weeks of treatment, researchers will check how many patients have cleared the virus from their blood. Those who achieve this response will continue to be followed for another 4 and 12 weeks after treatment to see if the virus remains undetectable.
Detailed description
An observational, prospective, single-cohort study will be conducted in patients with chronic hepatitis C virus infection of genotype 3 and fibrosis stage F0-F2 according to the METAVIR score based on liver elastography data, who have initiated antiviral therapy with ravidasvir and sofosbuvir as part of routine clinical practice.
Patients who have initiated antiviral therapy with ravidasvir and sofosbuvir, meet the inclusion criteria, and have signed informed consent for the use of their data in scientific research will be enrolled in the study. Patients will be followed in the clinic in accordance with routine medical practice during the course of ravidasvir and sofosbuvir antiviral therapy.
After 8 weeks of therapy, the rate of viral eradication in peripheral blood will be determined. Patients who achieve a virological response will continue to be followed to assess the maintenance of virological response at 4 and 12 weeks after completion of antiviral therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic hepatitis C virus infection genotype 3 with fibrosis stage F0-F2 were selected for this non-interventional study. These patients represent an important group with a high probability of successful therapy response and relatively low risk of complications, making them ideal candidates for studying the efficacy and safety of a short-term treatment regimen with ravidasvir and sofosbuvir. A similar patient population showed a high rate of sustained virological response (93.42%) in the EASE clinical trial (NCT05757700) with an 8-week therapy regimen. Despite the presence of significant data on treatment of chronic hepatitis C overall, detailed descriptions of disease epidemiology depending on virus genotype, fibrosis stage, and treatment efficacy in patients at early disease stages in real clinical practice are limited.
Key inclusion criteria (6 listed)
- Patient informed consent for the collection and use of data in scientific research.
- Diagnosed chronic hepatitis C (genotype 3).
- Fibrosis stage F0-F2 according to METAVIR, confirmed by liver biopsy or liver elastography (results of performed studies must be no older than 3 months at the start of antiviral therapy).
- Signed informed consent.
- Age ≥18 years.
Key exclusion criteria (5 listed)
- Significant concomitant liver diseases considered relevant by the investigator (hepatitis B, hemochromatosis, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, hepatocellular carcinoma).
- Presence of other active viral infections (e.g., hepatitis B, HIV).
- If the patient has received other antiviral treatment for hepatitis C within the last 6 months.
- Pregnancy or breastfeeding.
- Alcohol or drug dependence that may interfere with adherence to the treatment regimen.
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
Evaluation of the rate of achieving sustained virological response (SVR12)
Time frame: 20 weeks after enrollment to the study (8 weeks of antiviral treatment + 12 week of post-treatment follow up)
Absence of detectable hepatitis C virus (HCV) RNA in a patient's blood 12 weeks after completing antiviral treatment
3 secondary outcomes
Evaluation of the rate of achieving aviremia 4 weeks after completion of antiviral therapy (SVR-4)
Time frame: 12 weeks after enrollment (8 weeks of antiviral treatment + 4 weeks of post-treatment follow up)
Assessment of the dynamics of viral load changes during treatment
Time frame: At Week 4 after enrollment (therapy initiation), at Week 8 after enrollment (end of antiviral treatment), at Week 12 and Week 20 after enrollment (post-treatment follow up).
Assessment of the safety and tolerability of therapy.
Time frame: 20 weeks after enrollment (8 weeks of antiviral therapy and 12 weeks of post-treatment follow up)
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 5 Jan 2026.
- 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.
Pavel Bogomolov, Prof., PhD, MD principal investigator
Center of target therapy
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 Viral Hepatitis C, run by Center of target therapy at 1 site in Russia.
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 5 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 5 Jan 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 Russia. 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?
Evaluation of the rate of achieving sustained virological response (SVR12) (time frame: 20 weeks after enrollment to the study (8 weeks of antiviral treatment + 12 week of post-treatment follow up)). 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 5 Jan 2026.