Chronic Hepatitis BPhase 3NCT07095855
A Phase III Study to Evaluate the Efficacy and Safety of ZM-H1505R in Patients With CHB
A Phase 3 study testing ZM-H1505R 100mg and NAs （"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"or"TMF"） treatments in people with Chronic Hepatitis B, run by Shanghai Zhimeng Biopharma, Inc. at 1 site in China.
Trial summary
This study is divided into two parts. Part A is a multicenter, randomized, double-blind, placebo controlled phase Ill clinical trial, designed to evaluate the efficacy and safety of ZM-H1505R in combination with NAs versus NAs monotherapy with HBV DNA ≥ 50 IU/mL and are HBeAg positive who have received NAs monotherapy… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- ZM-H1505R 100mg and NAs （"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"or"TMF"） treatments
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,300 participants
- Where
- 1 siteChina
- Study dates
- Aug 2025to Jan 2030
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Able to understand and sign the written informed consent form;
- 2.Adult males and females aged 18-65 years(inclusive) at screening;
- 3.Have been used NAs monotherapy with ETV(0.5 mg or 1.0mg, QD),TDF (300 mg, QD),TAF (25 mg, QD),or TMF (25 mg, OD)for at least 12 months at the time of enrollment; Have been on stable and continuous use of one of these medications for at least 6months, and do not plan to switch to any other NAs class of medications after entering this clinical trial;
- 4.Evidence of prior HBV infection (e.g., HBsAg and/or HBV DNA positive), or HBsAg positive at screening;
- 5.HBV DNA ≥50 IU/mL as measured by a local healthcare facility within 30 days prior to screening and HBV DNA ≥50 IU/mL as confirmed by central laboratory testing at the time of screening;
- 6.HBeAg positivity confirmed by central laboratory testing at screening;
- 7.Women of childbearing potential or males with female partners of childbearing potential must agree to voluntarily use the contraceptive methods specified in the protocol from screening to 28 days after the last dose of the study.
Who cannot join
- 1.Progressive fibrosis or cirrhosis detected at screening, or progressive fibrosis or cirrhosis defined as follows: Metavir ≥ 3 or Ishak fibrosis score ≥ 4 by liver biopsy within 1 year prior to screening; or in the absence of an appropriate liver biopsy, liver stiffness test (FibroScan) ≥ 9 kPa within 3 months prior to screening, or liver stiffness test (FibroTouch) ≥ 9.6 kPa(FibroScan preferred) ;
- 2.History of hepatocellular carcinoma (HCC); or serum alpha-fetoprotein (AFP) ≥ 50 ng/mL at screening, or imaging examination such as abdominal ultrasound, CT (computed tomography) or MRI (magnetic resonance imaging) suggesting possible HCC;
- 3.Subjects meeting any of the following clinical laboratory parameters at screening:
- Hemoglobin < 110 g/L (for males) or < 100 g/L (for females);
- Platelet count < 90 × 109/L;
- Neutrophil count < 1.5 × 109/L;
Show all 22Show fewer
- Alanine aminotransferase (ALT) or Aspartate aminotransferase(AST)> 3 × upper limit of normal (×ULN);
- International normalized ratio (INR) of prothrombin time > 1.3;
- Albumin < 35 g/L;
- Total bilirubin > 2 × ULN, and direct bilirubin > 1.5 × ULN;
- Estimated glomerular filtration rate < 60 mL/min/1.73 m2(calculated using the CKD-MDRD formula).
- 4.Abnormal result of electrocardiogram (ECG) at screening and inappropriate for the study participation judged by the investigator; or QTcF (QT corrected using the Fridericia formula): > 450 ms for males, > 470 ms for females at screening;
- 5.Co-infection with human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or hepatitis E virus (HEV); Note: Subjects with positive HCV antibody (Ab) but negative HCV RNA and subjects with positive HEV immunoglobulin M (IgM) but negative HEV RNA will NOT be excluded.
- 6.Other malignancy unless the subject's malignancy has been cured by surgical resection (e.g., basal cell skin cancer); Note: Subjects who are suspected of having malignancy must be excluded regardless of evidence of local recurrence or metastasis.
- 7.History of chronic liver disease with a non-HBV etiology, such as alcoholic liver disease, autoimmune liver disease, hereditary liver disease, non-alcoholic fatty liver disease, except for simple fatty liver disease;
- 8.Other concurrent severe systemic diseases or clinical manifestations, for which the investigator considers not suitable to participate in this study;
- 9.Use of any investigational product or drug not approved by regulatory authorities within 3 months prior to screening;
- 10.History of persistent alcohol consumption (alcohol consumption exceeding 40 g ethanol for males or 20g ethanol for females per day on average) within 6 months prior to screening;
- 11.History of drug dependence or drug abuse;
- 12.Pregnant or breastfeeding women;
- 13.Known hypersensitivity to the active ingredient or formulation excipients of the investigational drug;
- 14.Inappropriate for the study participation for any reason not otherwise listed as judged by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Hospital of Jilin University
Changchun, Jilin, 130000
Junqi Niu, +8613756661205, junqiniu@aliyun.com
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled and Open-Label Extension Phase III Study to Evaluate the Efficacy and Safety of ZM-H1505R (Canocapavir) in Combination With Nucleos(t)Ide Analog(NAs) Compared With NAs Monotherapy in Patients With Chronic Hepatitis B Who Have Received NAs Monotherapy for at Least 12 Months
This study is divided into two parts. Part A is a multicenter, randomized, double-blind, placebo controlled phase Ill clinical trial, designed to evaluate the efficacy and safety of ZM-H1505R in combination with NAs versus NAs monotherapy with HBV DNA ≥ 50 IU/mL and are HBeAg positive who have received NAs monotherapy for at least 12months.Part B is an open-label extension and follow-up period designed to evaluate the long-term safety and efficacy of ZM-H1505R in combination with NAs.
Read the detailed description
This study is divided into two parts. Part A is a multicenter, randomized, double-blind, placebo controlled phase Ill clinical trial, designed to evaluate the efficacy and safety of ZM-H1505R in combination with NAs versus NAs monotherapy with HBV DNA ≥ 50 IU/mL and are HBeAg positive who have received NAs monotherapy for at least 12months.Part B is an open-label extension and follow-up period designed to evaluate the long-term safety and efficacy of ZM-H1505R in combination with NAs.
- Part A (Double-Blind Treatment Period): Eligible subjects will be randomized in a 1:1 ratio into 2 groups. Group A:ZM-H1505R 100mg +NAs Group B:ZM-H1505R placebo +NAs Two randomization stratification factors were set: NAs type of ETV, TDF,TAF, or TMF (no less than 15% of ETV, TDF, and TAF); HBV DNA <2000 IU/mL and HBV DNA >2000 IU/mL . All subjects completed a 48-week efficacy and safety evaluation followed by an interim analysis, the results of which were used to submit an NDA application.
- Part B (Open-Label Extension Period): At the end of the 48-week randomized double-blind treatment period, all eligible subjects will transfer to the open-label extension period and were treated with ZM-H1505R 100 mg +NAs while the study drug was evaluated for efficacy and safety until the end of the 144 weeks.
- Follow-up Period: At the end of the 144-week open-label extension period, all subjects will continue to take NAs, as a monotherapy for a 4-week follow-up period for observation of efficacy and safety of after discontinuation of study drug in ZM-H1505R .
- Conditions
- Chronic Hepatitis B
- Being tested
- ZM-H1505R 100mg, ZM-H1505R Placebo, NAs （"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"or"TMF"） treatments
- Keywords
- ZM-H1505R, Hepatitis B, CHB
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZM-H1505R 100mgDrug
ZM-H1505R(100mg,QD) will be used in Part A double-blind treatment period for 48 weeks and Part B open-label extension period 144 weeks.
ZM-H1505R PlaceboOther
ZM-H1505R Placebo(100mg,QD) will be used in Part A double-blind treatment period for 48 weeks.
NAs （"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"or"TMF"） treatmentsCombination product
All eligible subjects will be use NAs （"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"or"TMF"） treatments during the study for 148 weeks, including Part A and Part B.
Subjects will continue to use the NAs as combination therapy before enrollment, the dosage will not be adjusted during the study. Subjects use in accordance with medical advice andinstructions.
| Study group | Role | What they receive |
|---|---|---|
| Group A:ZM-H1505R + NAs | Experimental | ZM-H1505R 100mg,QD + NAs(ETV or TDF or TAF or TMF) Receives: Drug: ZM-H1505R 100mg; Combination Product: NAs （"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"or"TMF"） treatments |
| Group B: ZM-H1505R Placebo + NAs | Placebo comparator | ZM-H1505R Placebo 100mg,QD + NAs(ETV or TDF or TAF or TMF) Receives: Other: ZM-H1505R Placebo; Combination Product: NAs （"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"or"TMF"） treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects achieves complete virologic response (CVR) at week 48 of treatment.
To evaluate the efficacy of ZM-H1505R in combination with NAs versus NAs monotherapy in adult CHB subjects who have received NAs monotherapy for at least 12 months. (CVR is defined as HBV DNA ≤ 10 IU/mL)
Measured: 48 week
Secondary outcomes (10)
Safety of ZM-H1505R in combination with NAs versus NAs monotherapy in adult CHB subjects who have received NAs monotherapy for at least 12 months.
Safety during the 48-week double-blind treatment period, the open-label extension period, and the follow-up period.
Measured: From baseline to the end of follow-up period(Part A and Part B), assessed up to 148 weeks.
Percentage of subjects who achieve CVR at each scheduled visit other than week 48 visit
CVR is defined as HBV DNA ≤ 10 IU/mL).
Measured: Part A(double-blind treatment period):from baseline to week 48; Part B (open-label extension period and follow-up period):from week 48 to week 148.
Time to achieve CVR in each group
CVR is defined as HBV DNA ≤ 10 IU/mL
Measured: Part A(double-blind treatment period):from baseline to week 48
Percentage of subjects with quantitative HBV DNA ≤ 20 IU/mL
Measured: Part A(double-blind treatment period):from baseline to week 48; Part B (open-label extension period and follow-up period):from week 48 to week 148.
Changes from baseline in quantitative HBV RNA
Measured: Part A(double-blind treatment period):from baseline to week 48; Part B (open-label extension period and follow-up period):from week 48 to week 148.
Percentage of subjects who achieve LLOQ of quantitative HBV RNA
Measured: Part A(double-blind treatment period):from baseline to week 48; Part B (open-label extension period and follow-up period):from week 48 to week 148.
Changes from baseline in quantitative serum HBsAg
Measured: Part A(double-blind treatment period):from baseline to week 48; Part B (open-label extension period and follow-up period):from week 48 to week 148.
Changes from baseline in HBeAg at each scheduled visit
Measured: Part A(double-blind treatment period):from baseline to week 48; Part B (open-label extension period and follow-up period):from week 48 to week 148.
Changes from baseline in quantitative serum HBcrAg at each scheduled visit;
Measured: Part A(double-blind treatment period):from baseline to week 48; Part B (open-label extension period and follow-up period):from week 48 to week 148.
Changes from baseline in liver stiffness test (FibroScan/FibroTouch)
Measured: Part A(double-blind treatment period):at week24 and week 48; Part B (open-label extension period and follow-up period):from week 48 to week 148.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study startAug 2025 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhimeng Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095855
- Sponsor's protocol ID
- ZM-H1505R-301
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 3 Aug 2025
- 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 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled and Open-Label Extension Phase III Study to Evaluate the Efficacy and Safety of ZM-H1505R (Canocapavir) in Combination With Nucleos(t)Ide Analog(NAs) Compared With NAs Monotherapy in Patients With Chronic Hepatitis B Who Have Received NAs Monotherapy for at Least 12 Months
- ClinicalTrials.gov ID
- NCT07095855
- Acronym / sponsor ID
- ZM-H1505R-301
- Conditions
- Chronic Hepatitis B
- Keywords
- ZM-H1505R, Hepatitis B, CHB
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Shanghai Zhimeng Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2025 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 31 Jul 2025 (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 is divided into two parts. Part A is a multicenter, randomized, double-blind, placebo controlled phase Ill clinical trial, designed to evaluate the efficacy and safety of ZM-H1505R in combination with NAs versus NAs monotherapy with HBV DNA ≥ 50 IU/mL and are HBeAg positive who have received NAs monotherapy for at least 12months.Part B is an open-label extension and follow-up period designed to evaluate the long-term safety and efficacy of ZM-H1505R in combination with NAs.
Detailed description
This study is divided into two parts. Part A is a multicenter, randomized, double-blind, placebo controlled phase Ill clinical trial, designed to evaluate the efficacy and safety of ZM-H1505R in combination with NAs versus NAs monotherapy with HBV DNA ≥ 50 IU/mL and are HBeAg positive who have received NAs monotherapy for at least 12months.Part B is an open-label extension and follow-up period designed to evaluate the long-term safety and efficacy of ZM-H1505R in combination with NAs.
- Part A (Double-Blind Treatment Period): Eligible subjects will be randomized in a 1:1 ratio into 2 groups. Group A:ZM-H1505R 100mg +NAs Group B:ZM-H1505R placebo +NAs Two randomization stratification factors were set: NAs type of ETV, TDF,TAF, or TMF (no less than 15% of ETV, TDF, and TAF); HBV DNA <2000 IU/mL and HBV DNA >2000 IU/mL . All subjects completed a 48-week efficacy and safety evaluation followed by an interim analysis, the results of which were used to submit an NDA application.
- Part B (Open-Label Extension Period): At the end of the 48-week randomized double-blind treatment period, all eligible subjects will transfer to the open-label extension period and were treated with ZM-H1505R 100 mg +NAs while the study drug was evaluated for efficacy and safety until the end of the 144 weeks.
- Follow-up Period: At the end of the 144-week open-label extension period, all subjects will continue to take NAs, as a monotherapy for a 4-week follow-up period for observation of efficacy and safety of after discontinuation of study drug in ZM-H1505R .
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 |
|---|---|---|
| Group A:ZM-H1505R + NAs | Experimental | Drug: ZM-H1505R 100mg, Combination Product: NAs （"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"or"TMF"） treatmentsZM-H1505R 100mg,QD + NAs(ETV or TDF or TAF or TMF) |
| Group B: ZM-H1505R Placebo + NAs | Placebo comparator | Other: ZM-H1505R Placebo, Combination Product: NAs （"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"or"TMF"） treatmentsZM-H1505R Placebo 100mg,QD + NAs(ETV or TDF or TAF or TMF) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1.Able to understand and sign the written informed consent form;
- 2.Adult males and females aged 18-65 years(inclusive) at screening;
- 3.Have been used NAs monotherapy with ETV(0.5 mg or 1.0mg, QD),TDF (300 mg, QD),TAF (25 mg, QD),or TMF (25 mg, OD)for at least 12 months at the time of enrollment; Have been on stable and continuous use of one of these medications for at least 6months, and do not plan to switch to any other NAs class of medications after entering this clinical trial;
- 4.Evidence of prior HBV infection (e.g., HBsAg and/or HBV DNA positive), or HBsAg positive at screening;
- 5.HBV DNA ≥50 IU/mL as measured by a local healthcare facility within 30 days prior to screening and HBV DNA ≥50 IU/mL as confirmed by central laboratory testing at the time of screening;
Key exclusion criteria (22 listed)
- 1.Progressive fibrosis or cirrhosis detected at screening, or progressive fibrosis or cirrhosis defined as follows: Metavir ≥ 3 or Ishak fibrosis score ≥ 4 by liver biopsy within 1 year prior to screening; or in the absence of an appropriate liver biopsy, liver stiffness test (FibroScan) ≥ 9 kPa within 3 months prior to screening, or liver stiffness test (FibroTouch) ≥ 9.6 kPa(FibroScan preferred) ;
- 2.History of hepatocellular carcinoma (HCC); or serum alpha-fetoprotein (AFP) ≥ 50 ng/mL at screening, or imaging examination such as abdominal ultrasound, CT (computed tomography) or MRI (magnetic resonance imaging) suggesting possible HCC;
- 3.Subjects meeting any of the following clinical laboratory parameters at screening:
- 4.Abnormal result of electrocardiogram (ECG) at screening and inappropriate for the study participation judged by the investigator; or QTcF (QT corrected using the Fridericia formula): > 450 ms for males, > 470 ms for females at screening;
- 5.Co-infection with human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or hepatitis E virus (HEV); Note: Subjects with positive HCV antibody (Ab) but negative HCV RNA and subjects with positive HEV immunoglobulin M (IgM) but negative HEV RNA will NOT be excluded.
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 |
|---|---|---|
| ZM-H1505R 100mgZM-H1505R(100mg,QD) will be used in Part A double-blind treatment period for 48 weeks and Part B open-label extension period 144 weeks. | Drug | Group A:ZM-H1505R + NAs |
| ZM-H1505R PlaceboZM-H1505R Placebo(100mg,QD) will be used in Part A double-blind treatment period for 48 weeks. | Other | Group B: ZM-H1505R Placebo + NAs |
| NAs （"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"or"TMF"） treatmentsAll eligible subjects will be use NAs （"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"or"TMF"） treatments during the study for 148 weeks, including Part A and Part B. Subjects will continue to use the NAs as combination therapy before enrollment, the dosage will not be adjusted during the study. Subjects use in accordance with medical advice andinstructions. | Combination product | Group A:ZM-H1505R + NAs, Group B: ZM-H1505R Placebo + NAs |
Primary outcome
Percentage of subjects achieves complete virologic response (CVR) at week 48 of treatment.
Time frame: 48 week
To evaluate the efficacy of ZM-H1505R in combination with NAs versus NAs monotherapy in adult CHB subjects who have received NAs monotherapy for at least 12 months. (CVR is defined as HBV DNA ≤ 10 IU/mL)
10 secondary outcomes
Safety of ZM-H1505R in combination with NAs versus NAs monotherapy in adult CHB subjects who have received NAs monotherapy for at least 12 months.
Time frame: From baseline to the end of follow-up period(Part A and Part B), assessed up to 148 weeks.
Percentage of subjects who achieve CVR at each scheduled visit other than week 48 visit
Time frame: Part A(double-blind treatment period):from baseline to week 48; Part B (open-label extension period and follow-up period):from week 48 to week 148.
Time to achieve CVR in each group
Time frame: Part A(double-blind treatment period):from baseline to week 48
Percentage of subjects with quantitative HBV DNA ≤ 20 IU/mL
Time frame: Part A(double-blind treatment period):from baseline to week 48; Part B (open-label extension period and follow-up period):from week 48 to week 148.
Changes from baseline in quantitative HBV RNA
Time frame: Part A(double-blind treatment period):from baseline to week 48; Part B (open-label extension period and follow-up period):from week 48 to week 148.
Percentage of subjects who achieve LLOQ of quantitative HBV RNA
Time frame: Part A(double-blind treatment period):from baseline to week 48; Part B (open-label extension period and follow-up period):from week 48 to week 148.
Changes from baseline in quantitative serum HBsAg
Time frame: Part A(double-blind treatment period):from baseline to week 48; Part B (open-label extension period and follow-up period):from week 48 to week 148.
Changes from baseline in HBeAg at each scheduled visit
Time frame: Part A(double-blind treatment period):from baseline to week 48; Part B (open-label extension period and follow-up period):from week 48 to week 148.
Changes from baseline in quantitative serum HBcrAg at each scheduled visit;
Time frame: Part A(double-blind treatment period):from baseline to week 48; Part B (open-label extension period and follow-up period):from week 48 to week 148.
Changes from baseline in liver stiffness test (FibroScan/FibroTouch)
Time frame: Part A(double-blind treatment period):at week24 and week 48; Part B (open-label extension period and follow-up period):from week 48 to week 148.
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 3 Aug 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ZM-H1505R 100mg and NAs （"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"or"TMF"） treatments in people with Chronic Hepatitis B, run by Shanghai Zhimeng Biopharma, Inc. 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 7 inclusion and 22 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: opening soon, as of the sponsor's last update on 3 Aug 2025. 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 phase mean?
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?
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?
Contact Project Manager (+8615800984667, adeng@corebiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects achieves complete virologic response (CVR) at week 48 of treatment. (time frame: 48 week). 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 3 Aug 2025.