Hepatitis B, ChronicPhase 2NCT05484466
A Study to Evaluate the Efficacy and Safety of ZM-H1505R in Combination With ETV Compared With ETV Monotherapy in Patients With CHB
A Phase 2 study testing ZM-H1505R and Baraclude in people with Hepatitis B, Chronic, run by Shanghai Zhimeng Biopharma, Inc. at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled phase IIa study, designed to evaluate the efficacy and safety of ZM-H1505R in combination with Baraclude versus Baraclude monotherapy in adult CHB subjects with HBV DNA <2000 IU/mL but ≥ 50 IU/mL and who have received ETV (0.5 mg, once daily [QD)]… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- ZM-H1505R and Baraclude
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2022to 30 Dec 2024
- Phase
- Phase 2
- 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 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 (the informed consent should be obtained prior to any study procedure);
- 2.Males and females aged 18-65 (inclusive);
- 3.Have been used ETV (0.5 mg, QD) monotherapy for at least 12 months at the time of screening; and able to provide evidence of existing HBV infection (e.g., HBsAg and/or HBV DNA positive), or HBsAg positive at screening;
- 4.Plasma HBV DNA < 2000 IU/mL but ≥ 50 IU/mL in 2 consecutive tests at least 30 days apart during the screening period (serum samples will be delivered to the designated central laboratory for testing)
- 5.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 (see Appendix 1).
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;
- 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 < 120 g/L (for males) or < 110 g/L (for females);
- Platelet count < 100 × 109/L;
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- Neutrophil count < 1.5 × 109/L;
- Alanine aminotransferase (ALT) > 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, see Appendix 2).
- 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, including but not limited to:
- Circulatory system diseases: such as unstable angina, myocardial infarction, congestive heart failure, and poorly controlled or refractory hypertension (for example, after medication treatment, systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
- Respiratory system diseases: such as severe chronic obstructive pulmonary disease;
- Primary or secondary renal diseases (such as chronic renal decompensation and renal diseases associated with diabetes, hypertension, and vascular diseases);
- Endocrine system diseases: such as poorly controlled diabetes or thyroid disease;
- Autoimmune diseases: such as systemic lupus erythematosus, idiopathic thrombocytopenic purpura, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, autoimmune hemolytic anemia, and psoriasis;
- Neuropsychiatric diseases: such as epilepsy, schizophrenia, and depression;
- 9.Use of any investigational product or drug not approved by regulatory authorities within 3 months prior to screening;
- 10.History of persistent alcohol comsumption (alcohol consumption exceeding 40 g ethanol for males or 20 g 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.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130000
Junqi Niu, 13756661205, junqiniu@aliyun.com
About this study
Official title: A Phase IIa Study to Evaluate the Efficacy and Safety of ZM-H1505R in Combination With Entecavir (ETV) Compared With ETV Monotherapy in Patients With Chronic Hepatitis B Who Have Received ETV Monotherapy for at Least 12 Months
This is a multicenter, randomized, double-blind, placebo-controlled phase IIa study, designed to evaluate the efficacy and safety of ZM-H1505R in combination with Baraclude versus Baraclude monotherapy in adult CHB subjects with HBV DNA <2000 IU/mL but ≥ 50 IU/mL and who have received ETV (0.5 mg, once daily [QD)] monotherapy for at least 12 months.
The study is planned to enroll 90 adult CHB subjects who have received ETV monotherapy for at least 12 months and are still receiving ETV monotherapy (0.5 mg, QD) continuously. Eligible subjects will be randomized in a 1:1:1 ratio into 3 treatment groups. Both HBeAg positive and negative subjects will be included. There will be 20 HBeAg positive subjects and 10 HBeAg negative subjects in each treatment group.
After 48 weeks of treatment with the corresponding regimen, subjects will continue to take Baraclude 0.5 mg QD, as a monotherapy for a 12-week follow-up period for observation of efficacy and safety of ZM-H1505R.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled phase IIa study, designed to evaluate the efficacy and safety of ZM-H1505R in combination with Baraclude versus Baraclude monotherapy in adult CHB subjects with HBV DNA <2000 IU/mL but ≥ 50 IU/mL and who have received ETV (0.5 mg, once daily [QD)] monotherapy for at least 12 months.
The study is planned to enroll 90 adult CHB subjects who have received ETV monotherapy for at least 12 months and are still receiving ETV monotherapy (0.5 mg, QD) continuously. Eligible subjects will be randomized in a 1:1:1 ratio into 3 treatment groups. Both HBeAg positive and negative subjects will be included. There will be 20 HBeAg positive subjects and 10 HBeAg negative subjects in each treatment group. The treatment regimens in each group are as follows:
Group A: ZM-H1505R 50 mg QD + Baraclude 0.5 mg QD Group B: ZM-H1505R 100 mg QD + Baraclude 0.5 mg QD Group C: ZM-H1505R placebo QD + Baraclude 0.5 mg QD After 48 weeks of treatment with the corresponding regimen, subjects will continue to take Baraclude 0.5 mg QD, as a monotherapy for a 12-week follow-up period for observation of efficacy and safety of ZM-H1505R.
- Conditions
- Hepatitis B, Chronic
- Being tested
- ZM-H1505R, ZM-H1505R placebo, Baraclude
- Keywords
- Hepatitis B, Chronic, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IIa
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZM-H1505RDrug
There are three groups in this study. ZM-H1505R will be used in group A and Group B ，Subjects can use it for 48 weeks Group A: 30 subjects； ZM-H1505R 50 mg QD +ZM-H1505R placebo； Group B: 30 subjects； ZM-H1505R 100 mg QD
ZM-H1505R placeboOther
There are three groups in this study. ZM-H1505R will be used in group A and Group C ，Subjects can use it for 48 weeks Group A: 30 subjects；ZM-H1505R 50 mg +ZM-H1505R placebo 50mg QD ； Group C: 30 subjects；ZM-H1505R placebo 100mg QD
BaracludeCombination product
All subjects were orally administered once a day at night ： Baraclude® 0.5 mg QD，60weeks
| Study group | Role | What they receive |
|---|---|---|
| Group A:ZM-H1505R 50 mg QD + Baraclude 0.5 mg QD | Experimental | The treatment regimen is as follow:
Group A: ZM-H1505R 50 mg QD + Baraclude 0.5 mg QD 48weeks After 48 weeks of treatment with the corresponding regimen, subjects will continue to take Baraclude 0.5 mg QD, as a monotherapy for a 12-week . Receives: Drug: ZM-H1505R; Other: ZM-H1505R placebo; Combination Product: Baraclude |
| Group B:ZM-H1505R 100 mg QD + Baraclude 0.5 mg QD | Experimental | The treatment regimen is as follow:
Group B: ZM-H1505R 100 mg QD + Baraclude 0.5 mg QD 48weeks After 48 weeks of treatment with the corresponding regimen, subjects will continue to take Baraclude 0.5 mg QD, as a monotherapy for a 12-week . Receives: Drug: ZM-H1505R; Combination Product: Baraclude |
| Group C:ZM-H1505R placebo QD + Baraclude 0.5 mg QD | Placebo comparator | The treatment regimen is as follow:
Group C: ZM-H1505R placebo QD + Baraclude 0.5 mg QD 48weeks After 48 weeks of treatment with the corresponding regimen, subjects will continue to take Baraclude 0.5 mg QD, as a monotherapy for a 12-week . Receives: Other: ZM-H1505R placebo; Combination Product: Baraclude |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects who achieves complete virologic response (CVR) at week 24 of treatment period.
To evaluate the efficacy of ZM-H1505R in combination with ETV (Baraclude®) versus Baraclude® monotherapy in adult CHB subjects who have received ETV monotherapy for at least 12 months.
Percentage of subjects who achieves complete virologic response (CVR) at week 24 of treatment period.
(CVR is defined as HBV DNA ≤ 10 IU/mL.)
Measured: 24 weeks
To evaluate the safety of ZM-H1505R in combination with Baraclude versus Baraclude monotherapy in adult CHB subjects who have received ETV monotherapy for at least 12 months.
An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE was any unfavorable and unintended sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the investigational medicinal product.
Measured: 24 weeks
Secondary outcomes (13)
To evaluate the long-term safety of ZM-H1505R in combination with Baraclude® versus Baraclude® monotherapy in adult CHB subjects who have received ETV monotherapy for at least 12 months.
An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE was any unfavorable and unintended sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the investigational medicinal product.
Measured: 60 weeks
Percentage of subjects who achieves CVR at each scheduled visits other than week 24 visit
To evaluate the long-term safety of ZM-H1505R in combination with Baraclude versus Baraclude® monotherapy in adult CHB subjects who have received ETV monotherapy for at least 12 months.
Percentage of subjects who achieves CVR at each scheduled visits other than week 24 visit.
(CVR is defined as HBV DNA ≤ 10 IU/mL.)
Measured: 60 weeks
Time to achieve CVR in each group
To evaluate other virology indicators of ZM-H1505R in combination with Baraclude versus Baraclude monotherapy in adult CHB subjects who have received ETV monotherapy for at least 12 months.
Time to achieve CVR in each group (CVR is defined as HBV DNA ≤ 10 IU/mL.)
Measured: 60 weeks
Changes from baseline in quantitative HBV ribonucleic acid (RNA) at each scheduled visits
Change in Mean log10 HBV RNA From Baseline (Day -60 to Day -1) to Week 24, Week 48, or Week 60 on ZM-H1505R + SOC ETV as Compared to Placebo + SOC ETV Hepatitis B virus (HBV) RNA was measured using COBAS 6800. The lower limit of quantitation (LLOQ) was 10 Copies/mL.
Measured: Baseline, Week 24, Week 48 and Week 60
Percentage of subjects whose quantitative HBV RNA is ≤ 10 copies/mL at each scheduled visits
To evaluate other virology indicators of ZM-H1505R in combination with Baraclude versus Baraclude monotherapy in adult CHB subjects who have received ETV monotherapy for at least 12 months.
Percentage of subjects whose quantitative HBV RNA is ≤ 10 copies/mL at each scheduled visits
Measured: 60 weeks
Changes from baseline in quantitative hepatitis B surface antigen (HBsAg) at weeks 4, 12, 24, 36, 48, and 60
To evaluate other virology indicators of ZM-H1505R in combination with Baraclude versus Baraclude monotherapy in adult CHB subjects who have received ETV monotherapy for at least 12 months.
Changes from baseline in quantitative hepatitis B surface antigen (HBsAg) at weeks 4, 12, 24, 36, 48, and 60
Measured: Baseline;at weeks 4, 12, 24, 36, 48, and 60
Percentage of subjects achieving HBsAg loss at weeks 24, 48, and 60
To evaluate other virology indicators of ZM-H1505R in combination with Baraclude versus Baraclude monotherapy in adult CHB subjects who have received ETV monotherapy for at least 12 months.
- Percentage of subjects achieving HBsAg loss at weeks 24, 48, and 60; (HBsAg loss is defined as HBsAg positive before treatment and HBsAg negative after treatment.)
Measured: At weeks 24, 48, and 60
Percentage of subjects achieving HBsAg seroconversion at weeks 24, 48, and 60
To evaluate other virology indicators of ZM-H1505R in combination with Baraclude versus Baraclude monotherapy in adult CHB subjects who have received ETV monotherapy for at least 12 months.
Percentage of subjects achieving HBsAg seroconversion at weeks 24, 48, and 60; (HBsAg seroconversion is defined as HBsAg positive before treatment and HBsAg negative after treatment, with hepatitis B surface antibody [HBsAb] changed to positive.)
Measured: At weeks 24, 48, and 60
Percentage of subjects achieving hepatitis B e antigen (HBeAg) loss at weeks 24, 48, and 60
To evaluate other virology indicators of ZM-H1505R in combination with Baraclude versus Baraclude monotherapy in adult CHB subjects who have received ETV monotherapy for at least 12 months.
Percentage of subjects achieving hepatitis B e antigen (HBeAg) loss at weeks 24, 48, and 60 (only for subjects who are HBeAg positive at baseline); (HBeAg loss is defined as a subject who is HBeAg positive before treatment and becomes HBeAg negative after treatment.)
Measured: At weeks 24, 48, and 60
Percentage of subjects with HBeAg seroconversion at weeks 24, 48, and 60
To evaluate other virology indicators of ZM-H1505R in combination with Baraclude versus Baraclude monotherapy in adult CHB subjects who have received ETV monotherapy for at least 12 months.
Percentage of subjects with HBeAg seroconversion at weeks 24, 48, and 60 (only for subjects who are HBeAg positive at baseline); (HBeAg seroconversion is defined as HBeAg positive before treatment and HBeAg negative after treatment, with hepatitis B e antibody [HBeAb] changed to positive.)
Measured: At weeks 24, 48, and 60
Changes from baseline in quantitative hepatitis B core-related antigen (HBcrAg) at weeks 4, 12, 24, 36, 48, and 60
To evaluate other virology indicators of ZM-H1505R in combination with Baraclude versus Baraclude monotherapy in adult CHB subjects who have received ETV monotherapy for at least 12 months.
Changes from baseline in quantitative hepatitis B core-related antigen (HBcrAg) at weeks 4, 12, 24, 36, 48, and 60
Measured: Baseline；at weeks 4, 12, 24, 36, 48, and 60
THBV genotypic resistance.
The number of cases and percentages of subjects with HBV genotypic resistance.
Measured: 60 weeks
Plasma concentration of ZM-H1505R
For determination of ZM-H1505R plasma concentration, sparse PK blood samples will be collected in all subjects.
Measured: Baseline；at weeks 4, 12, 24, 36, 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start11 Nov 2022
- Primary completion20 Dec 2022
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is planned to enroll 90 adult CHB subjects who have received ETV monotherapy for at least 12 months and are still receiving ETV monotherapy (0.5 mg, QD) continuously. Eligible subjects will be randomized in a 1:1:1 ratio into 3 treatment groups. Both HBeAg positive and negative subjects will be included. There will be 20 HBeAg positive subjects and 10 HBeAg negative subjects in each treatment group. The treatment regimens in each group are as follows: Group A: ZM-H1505R 50 mg QD + Baraclude 0.5 mg QD Group B: ZM-H1505R 100 mg QD + Baraclude 0.5 mg QD Group C: ZM-H1505R placebo QD + Baraclude 0.5 mg QD After 48 weeks of treatment with the corresponding regimen, subjects will continue to take Baraclude 0.5 mg QD, as a monotherapy for a 12-week follow-up period for observation of efficacy and safety of ZM-H1505R.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhimeng Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Junqi Niu, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484466
- Sponsor's protocol ID
- ZM-H1505R-201
- Status last verified
- Jul 2022
- First submitted
- 20 Jul 2022
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Study to Evaluate the Efficacy and Safety of ZM-H1505R in Combination With Entecavir (ETV) Compared With ETV Monotherapy in Patients With Chronic Hepatitis B Who Have Received ETV Monotherapy for at Least 12 Months
- ClinicalTrials.gov ID
- NCT05484466
- Acronym / sponsor ID
- ZM-H1505R-201
- Conditions
- Hepatitis B, Chronic
- Keywords
- Hepatitis B, Chronic, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IIa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shanghai Zhimeng Biopharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 2 Aug 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.
This is a multicenter, randomized, double-blind, placebo-controlled phase IIa study, designed to evaluate the efficacy and safety of ZM-H1505R in combination with Baraclude versus Baraclude monotherapy in adult CHB subjects with HBV DNA <2000 IU/mL but ≥ 50 IU/mL and who have received ETV (0.5 mg, once daily [QD)] monotherapy for at least 12 months.
The study is planned to enroll 90 adult CHB subjects who have received ETV monotherapy for at least 12 months and are still receiving ETV monotherapy (0.5 mg, QD) continuously. Eligible subjects will be randomized in a 1:1:1 ratio into 3 treatment groups. Both HBeAg positive and negative subjects will be included. There will be 20 HBeAg positive subjects and 10 HBeAg negative subjects in each treatment group.
After 48 weeks of treatment with the corresponding regimen, subjects will continue to take Baraclude 0.5 mg QD, as a monotherapy for a 12-week follow-up period for observation of efficacy and safety of ZM-H1505R.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled phase IIa study, designed to evaluate the efficacy and safety of ZM-H1505R in combination with Baraclude versus Baraclude monotherapy in adult CHB subjects with HBV DNA <2000 IU/mL but ≥ 50 IU/mL and who have received ETV (0.5 mg, once daily [QD)] monotherapy for at least 12 months.
The study is planned to enroll 90 adult CHB subjects who have received ETV monotherapy for at least 12 months and are still receiving ETV monotherapy (0.5 mg, QD) continuously. Eligible subjects will be randomized in a 1:1:1 ratio into 3 treatment groups. Both HBeAg positive and negative subjects will be included. There will be 20 HBeAg positive subjects and 10 HBeAg negative subjects in each treatment group. The treatment regimens in each group are as follows:
Group A: ZM-H1505R 50 mg QD + Baraclude 0.5 mg QD Group B: ZM-H1505R 100 mg QD + Baraclude 0.5 mg QD Group C: ZM-H1505R placebo QD + Baraclude 0.5 mg QD After 48 weeks of treatment with the corresponding regimen, subjects will continue to take Baraclude 0.5 mg QD, as a monotherapy for a 12-week follow-up period for observation of efficacy and safety of 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
- 3
- Model description
- The study is planned to enroll 90 adult CHB subjects who have received ETV monotherapy for at least 12 months and are still receiving ETV monotherapy (0.5 mg, QD) continuously. Eligible subjects will be randomized in a 1:1:1 ratio into 3 treatment groups. Both HBeAg positive and negative subjects will be included. There will be 20 HBeAg positive subjects and 10 HBeAg negative subjects in each treatment group. The treatment regimens in each group are as follows: Group A: ZM-H1505R 50 mg QD + Baraclude 0.5 mg QD Group B: ZM-H1505R 100 mg QD + Baraclude 0.5 mg QD Group C: ZM-H1505R placebo QD + Baraclude 0.5 mg QD After 48 weeks of treatment with the corresponding regimen, subjects will continue to take Baraclude 0.5 mg QD, as a monotherapy for a 12-week follow-up period for observation of efficacy and safety of ZM-H1505R.
| Arm | Type | Receives |
|---|---|---|
| Group A:ZM-H1505R 50 mg QD + Baraclude 0.5 mg QD | Experimental | Drug: ZM-H1505R, Other: ZM-H1505R placebo, Combination Product: BaracludeThe treatment regimen is as follow: Group A: ZM-H1505R 50 mg QD + Baraclude 0.5 mg QD 48weeks After 48 weeks of treatment with the corresponding regimen, subjects will continue to take Baraclude 0.5 mg QD, as a monotherapy for a 12-week . |
| Group B:ZM-H1505R 100 mg QD + Baraclude 0.5 mg QD | Experimental | Drug: ZM-H1505R, Combination Product: BaracludeThe treatment regimen is as follow: Group B: ZM-H1505R 100 mg QD + Baraclude 0.5 mg QD 48weeks After 48 weeks of treatment with the corresponding regimen, subjects will continue to take Baraclude 0.5 mg QD, as a monotherapy for a 12-week . |
| Group C:ZM-H1505R placebo QD + Baraclude 0.5 mg QD | Placebo comparator | Other: ZM-H1505R placebo, Combination Product: BaracludeThe treatment regimen is as follow: Group C: ZM-H1505R placebo QD + Baraclude 0.5 mg QD 48weeks After 48 weeks of treatment with the corresponding regimen, subjects will continue to take Baraclude 0.5 mg QD, as a monotherapy for a 12-week . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1.Able to understand and sign the written informed consent form (the informed consent should be obtained prior to any study procedure);
- 2.Males and females aged 18-65 (inclusive);
- 3.Have been used ETV (0.5 mg, QD) monotherapy for at least 12 months at the time of screening; and able to provide evidence of existing HBV infection (e.g., HBsAg and/or HBV DNA positive), or HBsAg positive at screening;
- 4.Plasma HBV DNA < 2000 IU/mL but ≥ 50 IU/mL in 2 consecutive tests at least 30 days apart during the screening period (serum samples will be delivered to the designated central laboratory for testing)
- 5.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 (see Appendix 1).
Key exclusion criteria (29 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;
- 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;
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-H1505RThere are three groups in this study. ZM-H1505R will be used in group A and Group B ，Subjects can use it for 48 weeks Group A: 30 subjects； ZM-H1505R 50 mg QD +ZM-H1505R placebo； Group B: 30 subjects； ZM-H1505R 100 mg QD | Drug | Group A:ZM-H1505R 50 mg QD + Baraclude 0.5 mg QD, Group B:ZM-H1505R 100 mg QD + Baraclude 0.5 mg QD |
| ZM-H1505R placeboThere are three groups in this study. ZM-H1505R will be used in group A and Group C ，Subjects can use it for 48 weeks Group A: 30 subjects；ZM-H1505R 50 mg +ZM-H1505R placebo 50mg QD ； Group C: 30 subjects；ZM-H1505R placebo 100mg QD | Other | Group A:ZM-H1505R 50 mg QD + Baraclude 0.5 mg QD, Group C:ZM-H1505R placebo QD + Baraclude 0.5 mg QD |
| BaracludeAll subjects were orally administered once a day at night ： Baraclude® 0.5 mg QD，60weeks | Combination product | Group A:ZM-H1505R 50 mg QD + Baraclude 0.5 mg QD, Group B:ZM-H1505R 100 mg QD + Baraclude 0.5 mg QD, Group C:ZM-H1505R placebo QD + Baraclude 0.5 mg QD |
Primary outcome
Percentage of subjects who achieves complete virologic response (CVR) at week 24 of treatment period.
Time frame: 24 weeks
To evaluate the efficacy of ZM-H1505R in combination with ETV (Baraclude®) versus Baraclude® monotherapy in adult CHB subjects who have received ETV monotherapy for at least 12 months. Percentage of subjects who achieves complete virologic response (CVR) at week 24 of treatment period. (CVR is defined as HBV DNA ≤ 10 IU/mL.)
To evaluate the safety of ZM-H1505R in combination with Baraclude versus Baraclude monotherapy in adult CHB subjects who have received ETV monotherapy for at least 12 months.
Time frame: 24 weeks
An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE was any unfavorable and unintended sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the investigational medicinal product.
13 secondary outcomes
To evaluate the long-term safety of ZM-H1505R in combination with Baraclude® versus Baraclude® monotherapy in adult CHB subjects who have received ETV monotherapy for at least 12 months.
Time frame: 60 weeks
Percentage of subjects who achieves CVR at each scheduled visits other than week 24 visit
Time frame: 60 weeks
Time to achieve CVR in each group
Time frame: 60 weeks
Changes from baseline in quantitative HBV ribonucleic acid (RNA) at each scheduled visits
Time frame: Baseline, Week 24, Week 48 and Week 60
Percentage of subjects whose quantitative HBV RNA is ≤ 10 copies/mL at each scheduled visits
Time frame: 60 weeks
Changes from baseline in quantitative hepatitis B surface antigen (HBsAg) at weeks 4, 12, 24, 36, 48, and 60
Time frame: Baseline;at weeks 4, 12, 24, 36, 48, and 60
Percentage of subjects achieving HBsAg loss at weeks 24, 48, and 60
Time frame: At weeks 24, 48, and 60
Percentage of subjects achieving HBsAg seroconversion at weeks 24, 48, and 60
Time frame: At weeks 24, 48, and 60
Percentage of subjects achieving hepatitis B e antigen (HBeAg) loss at weeks 24, 48, and 60
Time frame: At weeks 24, 48, and 60
Percentage of subjects with HBeAg seroconversion at weeks 24, 48, and 60
Time frame: At weeks 24, 48, and 60
Changes from baseline in quantitative hepatitis B core-related antigen (HBcrAg) at weeks 4, 12, 24, 36, 48, and 60
Time frame: Baseline；at weeks 4, 12, 24, 36, 48, and 60
THBV genotypic resistance.
Time frame: 60 weeks
Plasma concentration of ZM-H1505R
Time frame: Baseline；at weeks 4, 12, 24, 36, 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
- 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.
Junqi Niu principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZM-H1505R and Baraclude in people with Hepatitis B, Chronic, 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 5 inclusion and 29 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 8 May 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Project Manager (15800984667, 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 who achieves complete virologic response (CVR) at week 24 of treatment period. (time frame: 24 weeks). 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 8 May 2023.