A Multicenter, Randomized, Open, Parallel-designed Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B
A Multicenter, Randomized, Open, Parallel-designed Phase II Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Contact
Study Contact
- Name: Xiaopeng Wang
- Phone Number: 0518-82342973
- Email: xiaopeng.wang@hengrui.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510515
- Recruiting
- Nanfang Hospital
-
Contact:
- Jinlin Hou
- Phone Number: 020-62787432
- Email: jlhousmu@163.com
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Meet the body mass index standard greater than or equal to 18.5 kg/m2 and less than 35 kg/m2;
- Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening;
- Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation;
- On commercially available NAs monotherapy for at least 24 weeks before randomization, and the dosing regimen remained unchanged for at least 4 weeks before randomization;
- Need to take effective contraceptive measures;
- Volunteer to sign an informed consent.
Exclusion Criteria:
- History of cirrhosis or clinical evidence of hepatic decompensation, confirmed or suspected liver cancer, with other liver diseases other than chronic hepatitis B that may affect the evaluation of the study;
- With autoimmune disease;
- History of solid organ transplantation or hematopoietic stem cell transplantation;
- Clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases;
- Malignant tumors were diagnosed within 5 years prior to randomization;
- Infection requiring intervention within 2 weeks prior to randomization;
- Major trauma or major surgery within the 12 weeks prior to randomization, or surgical plans or other treatment during the study period which the investigators determined may influence the evaluation of the study results;
- Laboratory tests during the screening period were obviously abnormal;
- Prolonged ECG QTcF or other clinically significant abnormal results that may pose a significant safety risk to the subject during the screening period;
- History of drug use, alcohol or drug abuse in the 12 months prior to randomization;
- Participated in clinical study of other drugs (received experimental drugs);
- Pregnant or nursing women;
- Allergic to a drug ingredient or component;
- Other reasons for ineligibility as judged by the investigators.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: HRS-5635 Injection dose 1
|
HRS-5635 Injection low dose administered by subcutaneous injection
HRS-5635 Injection medium dose administered by subcutaneous injection
HRS-5635 Injection high dose administered by subcutaneous injection
HRS-5635 Injection lowest dose administered by subcutaneous injection
HRS-5635 Injection, administered by subcutaneous injection
|
|
Experimental: HRS-5635 Injection dose 2
|
HRS-5635 Injection low dose administered by subcutaneous injection
HRS-5635 Injection medium dose administered by subcutaneous injection
HRS-5635 Injection high dose administered by subcutaneous injection
HRS-5635 Injection lowest dose administered by subcutaneous injection
HRS-5635 Injection, administered by subcutaneous injection
|
|
Experimental: HRS-5635 Injection dose 3
|
HRS-5635 Injection low dose administered by subcutaneous injection
HRS-5635 Injection medium dose administered by subcutaneous injection
HRS-5635 Injection high dose administered by subcutaneous injection
HRS-5635 Injection lowest dose administered by subcutaneous injection
HRS-5635 Injection, administered by subcutaneous injection
|
|
Experimental: HRS-5635 Injection dose 4
|
HRS-5635 Injection low dose administered by subcutaneous injection
HRS-5635 Injection medium dose administered by subcutaneous injection
HRS-5635 Injection high dose administered by subcutaneous injection
HRS-5635 Injection lowest dose administered by subcutaneous injection
HRS-5635 Injection, administered by subcutaneous injection
|
|
Experimental: HRS-5635 Injection (low dose) and Peg-IFN-α, administered by subcutaneous injection
|
HRS-5635 Injection (low dose) and Peg-IFN-α, administered by subcutaneous injection
|
|
Experimental: HRS-5635 Injection (high dose) and Peg-IFN-α, administered by subcutaneous injection
|
HRS-5635 Injection (high dose) and Peg-IFN-α, administered by subcutaneous injection
|
|
Placebo Comparator: Peg-IFN-α, administered by subcutaneous injection
|
Peg-IFN-α, administered by subcutaneous injection
|
|
Experimental: HRS-5635 Injection with Peg-IFN-α(Part C)
|
HRS-5635 Injection and Peg-IFN-α, administered by subcutaneous injection
|
|
Experimental: HRS-5635 Injection(Part D)
|
HRS-5635 Injection low dose administered by subcutaneous injection
HRS-5635 Injection medium dose administered by subcutaneous injection
HRS-5635 Injection high dose administered by subcutaneous injection
HRS-5635 Injection lowest dose administered by subcutaneous injection
HRS-5635 Injection, administered by subcutaneous injection
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
PartA:Change in mean log10 serum hepatitis B surface antigen levels from baseline at week 12
Time Frame: Week 12
|
Week 12
|
|
PartB:Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48
Time Frame: Week 48
|
Week 48
|
|
PartC:Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48
Time Frame: Week 48
|
Week 48
|
|
PartD:Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48
Time Frame: Week 48
|
Week 48
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes from baseline in mean log10 serum hepatitis B surface antigen levels
Time Frame: Pre-specified time points up to 72 weeks
|
Pre-specified time points up to 72 weeks
|
|
Proportion of subjects with at least one log10 decline from baseline in serum hepatitis B surface antigen
Time Frame: Pre-specified time points up to 72 weeks
|
Pre-specified time points up to 72 weeks
|
|
Proportion of subjects with serum hepatitis B surface antigen loss
Time Frame: Pre-specified time points up to 72 weeks
|
Pre-specified time points up to 72 weeks
|
|
Proportion of subjects with serum hepatitis B surface antigen seroconversion
Time Frame: Pre-specified time points up to 72 weeks
|
Pre-specified time points up to 72 weeks
|
|
Proportion of subjects with hepatitis B e-antigen loss
Time Frame: Pre-specified time points up to 72 weeks
|
Pre-specified time points up to 72 weeks
|
|
Proportion of subjects with serum hepatitis B e-antigen seroconversion
Time Frame: Pre-specified time points up to 72 weeks
|
Pre-specified time points up to 72 weeks
|
|
Proportion of subjects with virologic breakthrough
Time Frame: Pre-specified time points up to 72 weeks
|
Pre-specified time points up to 72 weeks
|
|
Proportion of subjects with drug resistance
Time Frame: Pre-specified time points up to 72 weeks
|
Pre-specified time points up to 72 weeks
|
|
Proportion of subjects who meet the criteria for stopping NA therapy
Time Frame: From 48 weeks to 72 weeks
|
From 48 weeks to 72 weeks
|
|
Proportion of subjects with serum hepatitis B surface antigen loss and HBV DNA loss
Time Frame: Week 48
|
Week 48
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Blood-Borne Infections
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Infections
- Virus Diseases
- Digestive System Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Communicable Diseases
- DNA Virus Infections
- Hepadnaviridae Infections
- Hepatitis, Chronic
- Hepatitis
- Pathological Conditions, Signs and Symptoms
- Hepatitis B
- Hepatitis B, Chronic
- Anti-Infective Agents
- Antineoplastic Agents
- Immunologic Factors
- Physiological Effects of Drugs
- Antiviral Agents
- Interferon alpha-2
- Interferon-alfa-1b
- Interferon-alpha
Other Study ID Numbers
Other Study ID Numbers
- HRS-5635-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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