A Phase 2 interventional study of hepalatide in Hepatitis D, sponsored by Shanghai HEP Pharmaceutical Co., Ltd.. Completed at 2 sites in Mongolia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Shanghai HEP Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment
The goal of this clinical trial is to evaluate the efficacy and safety of L47 in the treatment of chronic hepatitis D. Patients with compensated CHD who satisfy the eligibility criteria are stratified by the presence or absence of liver cirrhosis and randomized into three groups at a 1:1:1 ratio. The subjects will receive continuous L47 (2.1 mg/d and 4.2 mg/d, s.c.) treatment for 48 weeks (groups A and B), or delayed treatment for 48 weeks (group C). Primary endpoint evaluation will be performed after the subjects complete the 48-week treatment.
This is a three-arm, parallel-group, randomized, open-label, delayed-controlled phase IIb clinical trial. The study flow chart is shown in Fig. 1.2.1. CHD patients with compensated liver function who satisfy the eligibility criteria are stratified by the presence or absence of liver cirrhosis and randomized into the 2.1 mg group, 4.2 mg group, and delayed treatment group at a 1:1:1 ratio (Table 1.1). The subjects will receive continuous L47 (2.1 mg/d and 4.2 mg/d, s.c.) treatment for 48 weeks (groups A and B), or delayed treatment for 48 weeks (group C). The 1st interim analysis will be performed when all subjects complete the Week12 visit to determine the optimal dose for the extended treatment period following the trial. The 2nd interim analysis will be performed when all subjects complete the Week24 visit. Upon completion of the 48th week of treatment, the primary endpoint was assessed, and the trial was officially concluded.
After the conclusion of the trial, all subjects in each group entered the extension treatment period and were all treated continuously with the L47 optimal dose for 96 weeks. After the extension treatment ended, all groups discontinued the medication and were observed for 48 weeks follow-up.
63 studies on the registry are indexed under Hepatitis D; 21 are open to participants now.
This study's enrollment of 90 is above the median of 80 across 30 interventional studies indexed under Hepatitis D.
Browse Hepatitis D studies →Shanghai HEP Pharmaceutical Co., Ltd. is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
5. Subjects who have any of the following conditions:
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.
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.
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.
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.
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.
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.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
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.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
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.
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.
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.
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.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (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.
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.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
hepalatide 2.1mg/d, s.c. for 48 weeks
Drug: hepalatide
hepalatide 4.2mg/d, s.c. for 48 weeks
Drug: hepalatide
delayed treatment for 48 weeks
hepalatide of 2.1 mg/d or 4.2mg/d s.c. treatment for 48 weeks
Also known as: L47
compound response
Decrease in HDV RNV by ≥ 2 log10 from baseline and ALT normalization
Time frame: Week 48
HDV RNA below LLOQ
The incidence of subjects with HDV RNA lower than LLOQ.
Time frame: Week 48
Decrease in HDV RNA by ≥ 2 log10 from baseline or undetectable HDV RNA
The incidence of subjects with Decrease in HDV RNA by ≥ 2 log10 from baseline or undetectable HDV RNA
Time frame: Week 48
Decrease in HDV RNA from baseline
HDV RNA reduction from baseline.
Time frame: Week 48
ALT normalization
The rate of ALT relapse in subjects.
Time frame: Week 48
Decrease in ALT from baseline
ALT reduction from baseline.
Time frame: Week 48
Changes in subjects' METAVIR system scores from baseline.
The METAVIR score is a test used to determine the degree of inflammation and necrosis in the liver biopsy, as well as the extent of fibrosis. The degree of liver fibrosis is divided into five grades from F 0 to F4. The degree of inflammatory activity in liver tissue is divided into four grades from A0 to A3. Higher score means worse outcome. When the liver tissue inflammation and necrosis score decreased by ≥2 points compared with baseline (the change of inflammatory activity A value compared with baseline was ≤ -2 points), and there was no increase in liver fibrosis score; Or the liver fibrosis score decreased by ≥1 point (fibrosis stage F value change from baseline ≤ 0 points)，it means Liver tissue response.
Time frame: Week 48
Change in fibrosis 4 (FIB-4) index from baseline
Fibrosis 4（FIB-4）Index is a non-invasive method for assessing liver fibrosis in patients with chronic liver disease. The FIB-4 index is \<1.45, indicating no significant liver fibrosis or only 2nd degree or lower liver fibrosis. And the FIB-4 index\>3.25 indicates that the degree of liver fibrosis is 3-4 or higher.
Time frame: Week 48
Change in Child-Pugh score from baseline
Child-Pugh scores is a test that determines the scope and severity of liver failure as well as the prognosis for the patient. Three categories "A, B and C " indicate the severity of liver breakdown on the Child-Pugh rating scale. The higher the scale, the more serious outcomes.
Time frame: Week 48
Change in Model for End-Stage Liver Disease (MELD) score from baseline
R = 9.6 \\\* ln(serum creatinine in mg/dl) + 3.8 \\\* ln(bilirubin in mg/dl) + 11.2 \\\* ln(INR) + 6.4 \\\* cause (cause: cholestasis and alcoholic cirrhosis = 0, viral and other causes of cirrhosis = 1). The higher the R value, the greater the risk, and the lower the survival rate.
Time frame: Week 48
The incidence rate of Liver-related endpoint events.
The incidence of Liver-related endpoint events such as cirrhosis, hepatic decompensation, HCC, liver transplantation, liver-related death.
Time frame: Week 240
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. 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.