HCVPhase 2/3NCT03362814
Efficacy and Safety of Ravidasvir in Combination With Danoprevir/r and Ribavirin(RBV) in Treatment-naive, Non-cirrhotic, Chronic Hepatitis C Virus Genotype1 Infected Subjects.
A Phase 2/3 study testing Ravidasvir, Danoprevir and Ritonavir in people with HCV, run by Ascletis Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of Ravidasvir in combination with Danoprevir/r and ribavirin(RBV) by sustain virologic response 12 (SVR12), in treatment-naive, non-cirrhotic, chronic hepatitis C genotype 1 infected patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCV
- What is being tested?
- Ravidasvir, Danoprevir and Ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 425 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 24 Apr 2019
- Phase
- Phase 2/3
- 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
- Infection with Chronic hepatitis C genotype 1confirmed at screening;
- Anti-HCV positive；
- HCV RNA ≥1 × 10000IU / mL;
- Not treated with interferon and / or any other direct-acting antiviral (DAA) drug;
- Non-cirrhotic;
- Voluntarily sign informed consent.
Who cannot join
- HCV genotypes 2 to 7 or undetectable HCV genotype or mixed HCV genotype;
- Fibroscan detection result > 12.9kPa or Histopathological examination result of patients is with cirrhosis;
- Past or existing evidence of the presence of non-HCV-induced chronic liver disease;
- Previous history of hepatocellular carcinoma, or suspected hepatocellular carcinoma found prior to screening, or suspected abdominal hepatoblastoma at screening or AFP>100ng/mL;
- Anti-HAV (IgM) 、HBsAg 、anti-HEV (IgM) or anti-HIV is positive;
- BMI<18 or≥30 kg/m2;
- ANC<1.5×109/L、PLT<100×109/L、HB<110g/L（female）or<120g/L（male）；INR>1.5；ALT or AST≥5*ULN；TBIL≥2*ULN（DBIL≥ 35%TBIL）；Cr≥1.5*ULN;
- Others as specified in detailed protocol.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: A Phase2/3, Multi-center, Randomized, Double-blind, Placebo-parallel Controlled Study to Investigate the Efficacy and Safety of Ravidasvir in Combination With Danoprevir/r and Ribavirin(RBV) in Treatment-naive, Non-cirrhotic, Chronic Hepatitis C Genotype 1 Infected Subjects.
The purpose of this study is to assess the efficacy and safety of Ravidasvir in combination with Danoprevir/r and ribavirin(RBV) by sustain virologic response 12 (SVR12), in treatment-naive, non-cirrhotic, chronic hepatitis C genotype 1 infected patients.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RavidasvirDrug
Also called ASC16
Ravidasvir 200mg tablet administered orally once daily
DanoprevirDrug
Also called ASC08
Danoprevir 100mg tablet administered orally twice daily
RitonavirDrug
Ritonavir 100mg tablet administered orally twice daily
Ribavirin 100 MGDrug
Ribavirin tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations(<75kg = 1000mg and ≥75kg = 1200mg)
Ravidasvir PlaceboDrug
Ravidasvir Placebo tablet administered orally once daily
Danoprevir PlaceboDrug
Danoprevir Placebo tablet administered orally twice daily
Ritonavir PlaceboDrug
Ritonavir Placebo tablet administered orally twice daily
Ribavirin PlaceboDrug
Ribavirin Placebo tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations(<75kg = 5 tablets and ≥75kg = 6 tablets)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Ravidasvir + Danoprevir + Ritonavir + Ribavirin Receives: Drug: Ravidasvir; Drug: Danoprevir; Drug: Ritonavir; Drug: Ribavirin 100 MG |
| Placebo Group | Placebo comparator | Ravidasvir placebo + Danoprevir placebo + Ritonavir placebo + Ribavirin placebo Receives: Drug: Ravidasvir Placebo; Drug: Danoprevir Placebo; Drug: Ritonavir Placebo; Drug: Ribavirin Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants achieving sustained Virologic response 12 weeks after EOT
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks after cessation of therapy
Measured: Post treatment Week 12
Adverse events leading to permanent discontinuation of study drug
Measured: baseline to week 12
Secondary outcomes (5)
Percentage of Participants achieving sustained Virologic response 4 weeks after EOT
SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 4 weeks after cessation of therapy
Measured: Post treatment Week 4
Percentage of Participants achieving sustained Virologic response 24 weeks after EOT
SVR24 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 24 weeks after cessation of therapy
Measured: Post treatment Week 24
Quatitation change of HCV RNA compared to baseline after treatment
Measured: Baseline to week 1
Percentage of participants with viral breakthrough
Viral breakthrough was defined as HCV RNA ≥LLOQ after having previously had HCV RNA< LLOQ while receiving treatment, confirmed with 2 consecutive values
Measured: Baseline to week 12
Percentage of participants with viral relapse
Viral relapse was defined as HCV RNA ≥LLOQ during the post treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values.
Measured: End of treatment to post-treatment week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start1 Jul 2017
- Primary completion12 Dec 2018
- Study completion24 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCVStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yahong Chen, Master, Study director, Ascletis Pharmaceuticals Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362814
- Sponsor's protocol ID
- ASC-ASC16-II/III-CTP-1-01
- Status last verified
- Nov 2017
- First submitted
- 28 Nov 2017
- Last updated
- 28 Jul 2020
- 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 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase2/3, Multi-center, Randomized, Double-blind, Placebo-parallel Controlled Study to Investigate the Efficacy and Safety of Ravidasvir in Combination With Danoprevir/r and Ribavirin(RBV) in Treatment-naive, Non-cirrhotic, Chronic Hepatitis C Genotype 1 Infected Subjects.
- ClinicalTrials.gov ID
- NCT03362814
- Acronym / sponsor ID
- ASC-ASC16-II/III-CTP-1-01
- Conditions
- HCV
- Keywords
- HCV, Ravidasvir, SVR12
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 24 Apr 2019 (actual)
- First posted
- 5 Dec 2017 (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.
The purpose of this study is to assess the efficacy and safety of Ravidasvir in combination with Danoprevir/r and ribavirin(RBV) by sustain virologic response 12 (SVR12), in treatment-naive, non-cirrhotic, chronic hepatitis C genotype 1 infected patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Ravidasvir, Drug: Danoprevir, Drug: Ritonavir, Drug: Ribavirin 100 MGRavidasvir + Danoprevir + Ritonavir + Ribavirin |
| Placebo Group | Placebo comparator | Drug: Ravidasvir Placebo, Drug: Danoprevir Placebo, Drug: Ritonavir Placebo, Drug: Ribavirin PlaceboRavidasvir placebo + Danoprevir placebo + Ritonavir placebo + Ribavirin placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Infection with Chronic hepatitis C genotype 1confirmed at screening;
- Anti-HCV positive；
- HCV RNA ≥1 × 10000IU / mL;
- Not treated with interferon and / or any other direct-acting antiviral (DAA) drug;
- Non-cirrhotic;
Key exclusion criteria (8 listed)
- HCV genotypes 2 to 7 or undetectable HCV genotype or mixed HCV genotype;
- Fibroscan detection result > 12.9kPa or Histopathological examination result of patients is with cirrhosis;
- Past or existing evidence of the presence of non-HCV-induced chronic liver disease;
- Previous history of hepatocellular carcinoma, or suspected hepatocellular carcinoma found prior to screening, or suspected abdominal hepatoblastoma at screening or AFP>100ng/mL;
- Anti-HAV (IgM) 、HBsAg 、anti-HEV (IgM) or anti-HIV is positive;
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 |
|---|---|---|
| RavidasvirAlso: ASC16Ravidasvir 200mg tablet administered orally once daily | Drug | Experimental Group |
| DanoprevirAlso: ASC08Danoprevir 100mg tablet administered orally twice daily | Drug | Experimental Group |
| RitonavirRitonavir 100mg tablet administered orally twice daily | Drug | Experimental Group |
| Ribavirin 100 MGRibavirin tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations(<75kg = 1000mg and ≥75kg = 1200mg) | Drug | Experimental Group |
| Ravidasvir PlaceboRavidasvir Placebo tablet administered orally once daily | Drug | Placebo Group |
| Danoprevir PlaceboDanoprevir Placebo tablet administered orally twice daily | Drug | Placebo Group |
| Ritonavir PlaceboRitonavir Placebo tablet administered orally twice daily | Drug | Placebo Group |
| Ribavirin PlaceboRibavirin Placebo tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations(<75kg = 5 tablets and ≥75kg = 6 tablets) | Drug | Placebo Group |
Primary outcome
Percentage of Participants achieving sustained Virologic response 12 weeks after EOT
Time frame: Post treatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks after cessation of therapy
Adverse events leading to permanent discontinuation of study drug
Time frame: baseline to week 12
5 secondary outcomes
Percentage of Participants achieving sustained Virologic response 4 weeks after EOT
Time frame: Post treatment Week 4
Percentage of Participants achieving sustained Virologic response 24 weeks after EOT
Time frame: Post treatment Week 24
Quatitation change of HCV RNA compared to baseline after treatment
Time frame: Baseline to week 1
Percentage of participants with viral breakthrough
Time frame: Baseline to week 12
Percentage of participants with viral relapse
Time frame: End of treatment to post-treatment week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- 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.
Yahong Chen, Master study director
Ascletis Pharmaceuticals Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ravidasvir, Danoprevir and Ritonavir in people with HCV, run by Ascletis Pharmaceuticals Co., Ltd. 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 28 Jul 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of Participants achieving sustained Virologic response 12 weeks after EOT (time frame: Post treatment Week 12). The study lists 2 primary outcomes in all. 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 28 Jul 2020.