A Phase 2 interventional study of Hepalatide 2.1mg and Hepalatide 4.2mg in Hepatitis B, Chronic, sponsored by Shanghai HEP Pharmaceutical Co., Ltd.. Completed at 12 sites in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-01-27.
Sponsored by Shanghai HEP Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment
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Among 375 studies in Hepatitis B, Chronic with a site in China — 89 open to participants now, 110 under way, 7 of them phase 3. Hepatitis B, Chronic · China.
Among the 375 studies in Hepatitis B, Chronic with a site in China, this one is the 170th largest by enrollment of the 273 interventional ones that give a count, is one of 25 that started in 2021, is one of 72 in phase 2, and was the 189th registered.
896 studies on the registry are indexed under Hepatitis B, Chronic; 153 are open to participants now.
Browse Hepatitis B, Chronic studies →89 of the 375 studies in Hepatitis B, Chronic with a site in China are open now. Recruiting first, the newest first:
Jiyan Liu · Sites in China
Ages 18–65
Fujian Shengdi Pharmaceutical Co., Ltd. · Sites in China
Ages 18+
Fujian Akeylink Biotechnology Co., Ltd. · Sites in China
Ages 35–65
Ausper Biopharma Co., Ltd. · Sites in China
Ages 18–65 · Healthy volunteers
Zhiliang Gao · Sites in China
Ages 18–65 · Healthy volunteers
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 97 Hepatitis B, Chronic studies recruiting now, 33 (34%) set no upper age limit and 59 (61%) stop at 75 or younger; 11 take children under 18; 13 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
375 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 62 · Phase 2 85 · Phase 3 27 · Phase 4 73
First in 2000; this study’s year is marked. 25 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 96 is close to the median of 100 across 659 interventional studies indexed under Hepatitis B, Chronic.
Median enrollment 120 across the 273 interventional studies, 500 across the 99 observational. Of the 151 that completed or were terminated, 29 (19%) have results posted.
This tab as a report to print or save as PDF → With an account.
167 of 375 have an industry lead sponsor. The 10 most frequent:
Shanghai HEP Pharmaceutical Co., Ltd. is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Shanghai HEP Pharmaceutical Co., Ltd. has 4 studies filed under Hepatitis B, Chronic — fewer than ten, so there is no comparison to draw.
39 of the studies in Hepatitis B, Chronic with a site in China that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07090759Phase 3Fujian Akeylink Biotechnology Co., Ltd.To Evaluate the Efficacy, Safety and Population Pharmacokinetics of GST-HG141 in Patients With Chronic Hepatitis B (CHB) Who Have an Inadequate Response to Antiviral Drug Treatment | 2026-12-01 |
| NCT07246889Phase 3Ausper Biopharma Co., Ltd.Study of AHB-137 in Participants With Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogues (NAs)(AUSHINE) | 2026-12-18 |
| NCT07307586Phase 3Zhigang RenA Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatitis B | 2026-12-31 |
| NCT07203118Phase 3Xi'an Xintong Pharmaceutical Research Co.,Ltd.A Phase II/III of Hepenofovir Fumarate Tablets (HTS) for Chronic Hepatitis B | 2027-06-30 |
| NCT02863757Humanity and Health Research CentreFollow-up of Chronic Hepatitis B Patients With Comorbid Nonalcoholic Fatty Liver Disease | 2026-12 |
Add all 39 to your calendar (.ics) → With an account.
Among the 375 studies in Hepatitis B, Chronic with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A Phase II Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-effect Relationship Study of Hepalatide for Injection Combined with Pegylated Interferon in Subjects with Chronic Hepatitis B
The study is a 4-arm parallel design, randomized, double-blind, placebo-controlled, multicenter, dose-effect relationship, phase II clinical trial. The study is designed to assess efficacy and safety of 3 Doses of hepalatide in Combination with Pegylated Interferon Compared to Pegylated Interferon Alone in patients with Chronic Hepatitis B .Subjects will be randomly assigned to the 2.1mg, 4.2mg, and 6.3mg dose groups , 32 subjects in each group . The subjects in each dose group will be randomly and double-blindly administered the corresponding dose of trial drug or placebo in a ratio of 3:1. The subjects in each dose group who received placebo treatment combine as the placebo group. All subjects will receive Pegylated Interferon treatment for 28 weeks as the basic treatment,trial drug or placebo treatment for 24 weeks continuously , followed by a safety follow-up for 4 weeks.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepalatide 2.1mg s.c., q.d., treatment continued for 24 weeks, follow up 4 weeks. PEG-IFNalpha, s.c., q.w.,treatment continued for 48 weeks
Drug: Hepalatide 2.1mg · Drug: Pegylated Interferon
Hepalatide 4.2mg s.c., q.d., treatment continued for 24 weeks, follow up 4 weeks. PEG-IFNalpha, s.c., q.w.,treatment continued for 48 weeks
Drug: Hepalatide 4.2mg · Drug: Pegylated Interferon
Hepalatide 6.3mg s.c., q.d., treatment continued for 24 weeks, follow up 4 weeks. PEG-IFNalpha, s.c., q.w.,treatment continued for 48 weeks
Drug: Hepalatide 6.3mg · Drug: Pegylated Interferon
Hepalatide placebo s.c., q.d., treatment continued for 24 weeks, follow up 4 weeks. PEG-IFNalpha, s.c., q.w.,treatment continued for 48 weeks
Drug: placebo 2.1mg · Drug: placebo 4.2mg · Drug: placebo 6.3mg · Drug: Pegylated Interferon
2.1 mg/day subcutaneously (s.c.) for 24 week
Also known as: L47
4.2mg/day subcutaneously (s.c.) for 24 week
Also known as: L47
6.3mg/day subcutaneously (s.c.) for 24 week
Also known as: L47
2.1 mg/day subcutaneously (s.c.) for 24 week
4.2 mg/day subcutaneously (s.c.) for 24 week
6.3 mg/day subcutaneously (s.c.) for 24 week
180 ug/week subcutaneously (s.c.) for 28 week
Also known as: Pegasys
virological response
Time frame: 24weeks
HBV DNA down from baseline
HBV DNA down from baseline log10
Time frame: 24weeks
Virological suppression
HBV DNA \<2,000 IU/ml
Time frame: 24weeks
No response
HBsAg \>20,000 IU/ml and HBV DNA lower than baseline \<2log10 IU/ml
Time frame: 24weeks
Partial virological response
HBV DNA \>20 IU/ml and ≥2log10 IU/ml lower than baseline
Time frame: 24weeks
HBsAg is down from baseline
HBsAg is down from baseline log10
Time frame: 24weeks
HBeAg turned negative
HBeAg \<0.05 index
Time frame: 24weeks
HBeAg is down from baseline
HBeAg is down from baseline log10
Time frame: 24weeks
ALT recurrence
ALT≤1.25×ULN
Time frame: 24weeks
Histological response
Liver tissue inflammatory necrosis score reduced by ≥2 points with no increased liver fibrosis score; liver fibrosis score reduced by ≥1 point
Time frame: 24weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2021 to primary completion in Nov 2023, 28 months.
Of 75 industry-sponsored phase 2 interventional studies under Hepatitis B, Chronic, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 39. This study's 28 months is above that.
Counting every sponsor, half of 87 studies reached it within 23 months; a quarter within 16 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hepalatide
Shanghai HEP Pharmaceutical Co., Ltd.