Chronic HCV InfectionPhase 2/3NCT05395416
Antaitavir Hasophate Capsules Combined With Yiqibuvir Tablets in Treatment Adult Patients With Chronic Hepatitis C
A Phase 2/3 study testing HEC74647PA+HEC110114 in people with Chronic HCV Infection, run by Sunshine Lake Pharma Co., Ltd. at 36 sites in China.
Trial summary
The safety, tolerability and antiviral activity of Antaitavir Hasophate in Combination With Yiqibuvir in treatment-naive and treatment-experienced patients with chronic hepatitis C virus (HCV) infection Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic HCV Infection
- What is being tested?
- HEC74647PA+HEC110114
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 514 participants
- Where
- 36 sitesChina
- Study dates
- 21 Jun 2021to 11 Apr 2023
- 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
- Willing and able to provide written informed consent;
- Male or female, age≥18 years;
- Body mass index (BMI)≥18.0 and≤32.0 kg/m2, and Weight≥40 kg;
- Serological detection of anti-HCV antibodies was positive at screening;
- HCV RNA≥1×104 IU/mL at Screening;
- HCV genotype 1~6, mixed genotype or indeterminate assessed at Screening by the Central Laboratory.
Who cannot join
- Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage);
- Chronic liver disease of a non-HCV etiology (Including but not limited to hemochromatosis, Wilson's disease,alfa-1 antitrypsin deficiency);
- Significant cardiac disease(Including but not limited to myocardial infarction, bradycardia) ;
- Psychiatric illness or psychological disease or relevant medical history;
- Solid organ transplantation;
- Subjects have any other medical disorder that may interfere with subjects treatment, assessment or compliance with the protocol.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
China36 sites
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102200
Beijing You'an Hospital,Capital Medical University
Beijing
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui
The First Hospital of Jilin University
Changchun, Jilin
Hunan Provincial People's Hospital
Changsha, Hunan
Xiangya Hospital Central South University
Changsha, Hunan
Foshan First People's Hospital
Foshan, Guangdong
The 900th Hospital of the Joint Logistics Support Force Hospital
Fuzhou, Fujian
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong
The Fourth Affiliated Hospital of Harbin Medical University
Haerbin, Heilongjiang
Hainan Provincial People's Hospital
Haikou, Hainan
The Second Hospital of Anhui Medical University
Hefei, Anhui
Anhui Provincial Hospital
Hefei, Anwei
The First Affiliated Hospital of South China
Hengyang, Hunan
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu
Luoyang Central Hospital
Luoyang, Henan
Jiangsu Provincial Hospital
Nanjing, Jiangsu
Nanjing Second Hospital
Nanjing, Jiangsu
The First Affiliated Hospital of Nanchang University
Nanyang, Jiangxi
Qingdao Municipal Hospital
Qingdao, Shandong
Huashan Hospital of the Fudan University
Shanghai, Shanghai Municipality
The Sixth People's Hospital Of Shenyang
Shenyang, Liaoning
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality
Tonghua Central Hospital
Tonghua, Jilin
Wuhan University People's Hospital
Wuhan, Hebei
Wuxi No.5 People's Hospital
Wuxi, Jiangsu
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Yanbian University Hospital
Yanbian, Jilin
Henan Infectious Diseases Hospital
Zhengzhou, Henan
Henan Provincial People's Hospital
Zhengzhou, Henan
Zhengzhou People's Hospital
Zhengzhou, Henan
Zhenjiang Third People's Hospital
Zhenjiang, Jiangsu
About this study
Official title: A Phase Ⅱ/Ⅲ Study to Evaluate Efficacy and Safety of Antaitavir Hasophate Capsules in Combination With Yiqibuvir Tablets in Adult Subject With Chronic HCV Infection
The safety, tolerability and antiviral activity of Antaitavir Hasophate in Combination With Yiqibuvir in treatment-naive and treatment-experienced patients with chronic hepatitis C virus (HCV) infection
Read the detailed description
Phase II: Exploring the efficacy and safety of different doses of Antaitavir Hasophate combined with fixed-dose Yiqibuvir in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a basis for the design and implementation of phase III clinical trials.
Phase III: Confirmation of the efficacy and safety of Antaitavir Hasophate combined with Yiqibuvir in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a sufficient basis for drug registration and clinical use.
- Conditions
- Chronic HCV Infection
- Being tested
- HEC74647PA+HEC110114, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEC74647PA+HEC110114Drug
Also called Antaitavir Hasophate+Yiqibuvir
administered orally once daily for 12 weeks
PlaceboDrug
administered orally once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| HEC74647PA+HEC110114 100 mg/200 mg | Experimental | Phase II: HCV GT 1-6 participants were medicated with HEC74647PA Capsules 100 mg or200 mg once daily and HEC110114 tablets 600 mg once daily Receives: Drug: HEC74647PA+HEC110114 |
| HEC74647PA+HEC110114 | Experimental | Phase III: HCV GT 1-6 participants were medicated with HEC74647PA Capsules 100 mg /200 mg once daily and HEC110114 tablets 600 mg once daily Receives: Drug: HEC74647PA+HEC110114 |
| Placebo | Placebo comparator | Phase III: HCV GT 1-6 participants were medicated with HEC74647PA Placebo Capsules once daily and HEC110114 Placebo tablets once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virologic response at 12 weeks after end of treatment (SVR12)
Percentage of subjects with plasma HCV RNA not detected or below the lower limit of quantitation (15 IU/mL)
Measured: Posttreatment Week 12
Type and frequencies of Adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Up to posttreatment week 24
Secondary outcomes (2)
Percentage of subjects with sustained virologic response 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < the lower limit of quantitation (LLOQ) at 4 and 24 weeks after stopping study treatment, respectively
Measured: Posttreatment Weeks 4 and 24
Percentage of subjects with virologic failure
- On-treatment virologic failure: Breakthrough (confirmed HCV RNA ≥the lower limit of quantitation (LLOQ) after having previously had HCV RNA <the lower limit of quantitation (LLOQ) while on treatment), or Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment);
- Virologic relapse: Confirmed HCV RNA ≥the lower limit of quantitation (LLOQ) during the posttreatment period having achieved HCV RNA <the lower limit of quantitation (LLOQ) at last on-treatment visit.
Measured: Up to posttreatment week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start21 Jun 2021
- Primary completion11 Apr 2023
- Study completion11 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic HCV InfectionStudies of the same condition, open and under way.
- More trials run by Sunshine Lake Pharma Co., Ltd.The 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
- 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
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lai Wei, Doctor, Study chair, Beijing Tsinghua Changgeng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395416
- Sponsor's protocol ID
- HEC74647/HEC110114-Ⅱ/Ⅲ-01
- Status last verified
- May 2022
- First submitted
- 20 May 2022
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅱ/Ⅲ Study to Evaluate Efficacy and Safety of Antaitavir Hasophate Capsules in Combination With Yiqibuvir Tablets in Adult Subject With Chronic HCV Infection
- ClinicalTrials.gov ID
- NCT05395416
- Acronym / sponsor ID
- HEC74647/HEC110114-Ⅱ/Ⅲ-01
- Conditions
- Chronic HCV Infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 11 Apr 2023 (actual)
- First posted
- 27 May 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.
The safety, tolerability and antiviral activity of Antaitavir Hasophate in Combination With Yiqibuvir in treatment-naive and treatment-experienced patients with chronic hepatitis C virus (HCV) infection
Detailed description
Phase II: Exploring the efficacy and safety of different doses of Antaitavir Hasophate combined with fixed-dose Yiqibuvir in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a basis for the design and implementation of phase III clinical trials.
Phase III: Confirmation of the efficacy and safety of Antaitavir Hasophate combined with Yiqibuvir in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a sufficient basis for drug registration and clinical use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HEC74647PA+HEC110114 100 mg/200 mg | Experimental | Drug: HEC74647PA+HEC110114Phase II: HCV GT 1-6 participants were medicated with HEC74647PA Capsules 100 mg or200 mg once daily and HEC110114 tablets 600 mg once daily |
| HEC74647PA+HEC110114 | Experimental | Drug: HEC74647PA+HEC110114Phase III: HCV GT 1-6 participants were medicated with HEC74647PA Capsules 100 mg /200 mg once daily and HEC110114 tablets 600 mg once daily |
| Placebo | Placebo comparator | Drug: PlaceboPhase III: HCV GT 1-6 participants were medicated with HEC74647PA Placebo Capsules once daily and HEC110114 Placebo tablets once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Willing and able to provide written informed consent;
- Male or female, age≥18 years;
- Body mass index (BMI)≥18.0 and≤32.0 kg/m2, and Weight≥40 kg;
- Serological detection of anti-HCV antibodies was positive at screening;
- HCV RNA≥1×104 IU/mL at Screening;
Key exclusion criteria (6 listed)
- Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage);
- Chronic liver disease of a non-HCV etiology (Including but not limited to hemochromatosis, Wilson's disease,alfa-1 antitrypsin deficiency);
- Significant cardiac disease(Including but not limited to myocardial infarction, bradycardia) ;
- Psychiatric illness or psychological disease or relevant medical history;
- Solid organ transplantation;
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 |
|---|---|---|
| HEC74647PA+HEC110114Also: Antaitavir Hasophate+Yiqibuviradministered orally once daily for 12 weeks | Drug | HEC74647PA+HEC110114, HEC74647PA+HEC110114 100 mg/200 mg |
| Placeboadministered orally once daily for 12 weeks | Drug | Placebo |
Primary outcome
Sustained virologic response at 12 weeks after end of treatment (SVR12)
Time frame: Posttreatment Week 12
Percentage of subjects with plasma HCV RNA not detected or below the lower limit of quantitation (15 IU/mL)
Type and frequencies of Adverse events
Time frame: Up to posttreatment week 24
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
2 secondary outcomes
Percentage of subjects with sustained virologic response 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24)
Time frame: Posttreatment Weeks 4 and 24
Percentage of subjects with virologic failure
Time frame: Up to posttreatment 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 14 May 2025.
Related trials for Chronic HCV Infection
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
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.
Lai Wei, Doctor study chair
Beijing Tsinghua Changgeng Hospital
36 sites 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 HEC74647PA+HEC110114 in people with Chronic HCV Infection, run by Sunshine Lake Pharma Co., Ltd. at 36 sites 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 6 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 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites 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?
Sustained virologic response at 12 weeks after end of treatment (SVR12) (time frame: Posttreatment 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 14 May 2025.