Chronic Hepatitis D InfectionPhase 2NCT05827146
Study of Hepalatide in Chronic Hepatitis D(CHD) Patients
A Phase 2 study testing Hepalatide in people with Chronic Hepatitis D Infection, run by Shanghai HEP Pharmaceutical Co., Ltd. at 3 sites in 2 countries.
Trial summary
A phase 2a clinical Study of Hepalatide for Injection in Subjects with Chronic Hepatitis D Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis D Infection
- What is being tested?
- Hepalatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 7 Oct 2023to 1 Feb 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
- Male or female, 18-65 years old (both inclusive);
- HBsAg (+) and/or HBV DNA (+) for at least 6 months (clinically diagnosed as "chronic hepatitis B");
- HDV-antibody (IgG/IgM) (+) and HDV RNA (+);
- 1×ULN <ALT<10×ULN；
- Patients with hepatitis B eligible to receive treatment with NAs according to current guidelines for the diagnosis and treatment of hepatitis B;
- Patients who do not plan a pregnancy within two years (women who are not pregnant or lactating) and agree to take effective contraceptive measures throughout the treatment period and within 3 months after the last dose;
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- Patients who did not participate in any other clinical trials within 3 months;
- Patients with good compliance with the study protocol;
- Patients who understand and agree to sign an informed consent form.
Who cannot join
- Decompensated liver disease: Direct bilirubin > 1.2× ULN, prothrombin time > 1.2× ULN, and serum albumin < 35 g/L;
- Patients with abnormal results of routine hematology test: White blood cell count (WBC) < 3×109/L, neutrophil count < 1.5×109/L and platelet count < 60×109/L;
- Severely decompensated hepatic fiborosis or decompensated cirrhosis: Definitely diagnosed decompensated cirrhosis by imaging examinations such as a Color Doppler ultrasound and CT of the abdomen or clinically diagnosed decompensated cirrhosis by the investigator, or a Metavir fibrosis score of 4 on a liver biopsy sample, or a Child-Pugh score > 7 for liver function assessment;
- Patients who have any of the following conditions:
- A history of decompensated liver disease (ascites, jaundice, hepatic encephalopathy, variceal bleeding);
- A history of serious cardiovascular disease (including unstable or uncontrolled cardiovascular disease within 6 months);
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- Serious mental illness or a history of serious mental illness;
- A history of organ transplantation;
- Uncontrolled epilepsy, mental illness, or poorly controlled diabetes or hypertension;
- Autoimmune disease, immune-related extrahepatic manifestations (vasculitis, purpura, arteritis nodosa, peripheral neuropathy, and glomerulonephritis), thyroid disease, malignant tumor, and receiving immunosuppressive therapy;
- Underlying diseases such as severe infection, heart failure, chronic obstructive pulmonary disease, and other severe diseases;
- A history of alcohol or drug abuse.
- Creatinine clearance < 60 mL/min;
- HAV/HCV/HEV/HIV co-infection;
- Resistance to or poor response to Entecavir;
- An allergic reaction to Entecavir;
- Patients who have used interferon within 3 months before the screening period;
- Previously received L47 or Bulevirtide;
- Women who have a positive pregnancy test;
- Patients who have other significantly abnormal results of laboratory or auxiliary tests and are unsuitable for this trial.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
China2 sites
The first hospital of Jilin University
Changchun
The first affiliated hospital of Xinjiang Medical University
Ürümqi, Xinjiang
About this study
Official title: Double-blinded, Placebo-controlled, Munticenter, Phase IIa Clinical Trial of Hepalatide in Patients With Chronic Hepatitis D
A phase 2a clinical Study of Hepalatide for Injection in Subjects with Chronic Hepatitis D
Read the detailed description
This is a four-arm parallel-group, randomized, placebo-controlled, double-blind, multicenter Phase IIa clinical trial. The CHD subjects who meet the eligibility criteria will be randomly assigned 1:1:1:1 to receive either the placebo or investigational drug (2.1 mg, 4.2 mg, or 6.3 mg), with 6 subjects per group . The placebo or the corresponding dose of the investigational drug will be given for 4 consecutive weeks, followed by a 4-week follow-up period. Subjects will be given entecavir for the treatment of hepatitis B infection during and after the end of the trial.
- Conditions
- Chronic Hepatitis D Infection
- Being tested
- Hepalatide, Hepalatide Placebo
- Keywords
- chronic hepatitis D, hepalatide, hepatitis D virus
- Medical subject headings
- Hepatitis D, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepalatideDrug
Also called L47
Either the placebo or hepalatide (2.1 mg, 4.2 mg, or 6.3 mg) will be given for 4 consecutive weeks. s.c., once daily.
Hepalatide PlaceboDrug
Also called Placebo
Either the placebo or hepalatide (2.1 mg, 4.2 mg, or 6.3 mg) will be given for 4 consecutive weeks. s.c., once daily.
| Study group | Role | What they receive |
|---|---|---|
| Hepalatide 2.1mg | Experimental | 2.1 mg/day subcutaneously (s.c.) for 4 week Receives: Drug: Hepalatide |
| Hepalatide 4.2mg | Experimental | 4.2 mg/day subcutaneously (s.c.) for 4 week Receives: Drug: Hepalatide |
| Hepalatide 6.3mg | Experimental | 6.3 mg/day subcutaneously (s.c.) for 4 week Receives: Drug: Hepalatide |
| Placebo 2.1mg/4.2mg/6.3mg | Placebo comparator | Placebo 2.1 mg/4.2mg/6.3mg, once a day subcutaneously (s.c.) for 4 week Receives: Drug: Hepalatide Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatitis D Virus(HDV) RNA level
HDV RNA level at week4
Measured: Week 4
Secondary outcomes (2)
Change in Alanine transaminase(ALT) from baseline
Changes in ALT values at Week 4 compared to baseline
Measured: Week 4
Change in HDV RNA from baseline
Changes in HDV RNA levels at Week 4 compared to baseline
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start7 Oct 2023
- Primary completion30 Jan 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis D InfectionStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai HEP Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Junqi Niu, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827146
- Sponsor's protocol ID
- L47-HD-IIa
- Status last verified
- Apr 2024
- First submitted
- 17 Feb 2023
- Last updated
- 24 Apr 2024
- Results posted
- 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 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blinded, Placebo-controlled, Munticenter, Phase IIa Clinical Trial of Hepalatide in Patients With Chronic Hepatitis D
- ClinicalTrials.gov ID
- NCT05827146
- Acronym / sponsor ID
- L47-HD-IIa
- Conditions
- Chronic Hepatitis D Infection
- Keywords
- chronic hepatitis D, hepalatide, hepatitis D virus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Shanghai HEP Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Oct 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 24 Apr 2023 (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.
A phase 2a clinical Study of Hepalatide for Injection in Subjects with Chronic Hepatitis D
Detailed description
This is a four-arm parallel-group, randomized, placebo-controlled, double-blind, multicenter Phase IIa clinical trial. The CHD subjects who meet the eligibility criteria will be randomly assigned 1:1:1:1 to receive either the placebo or investigational drug (2.1 mg, 4.2 mg, or 6.3 mg), with 6 subjects per group . The placebo or the corresponding dose of the investigational drug will be given for 4 consecutive weeks, followed by a 4-week follow-up period. Subjects will be given entecavir for the treatment of hepatitis B infection during and after the end of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hepalatide 2.1mg | Experimental | Drug: Hepalatide2.1 mg/day subcutaneously (s.c.) for 4 week |
| Hepalatide 4.2mg | Experimental | Drug: Hepalatide4.2 mg/day subcutaneously (s.c.) for 4 week |
| Hepalatide 6.3mg | Experimental | Drug: Hepalatide6.3 mg/day subcutaneously (s.c.) for 4 week |
| Placebo 2.1mg/4.2mg/6.3mg | Placebo comparator | Drug: Hepalatide PlaceboPlacebo 2.1 mg/4.2mg/6.3mg, once a day subcutaneously (s.c.) for 4 week |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female, 18-65 years old (both inclusive);
- HBsAg (+) and/or HBV DNA (+) for at least 6 months (clinically diagnosed as "chronic hepatitis B");
- HDV-antibody (IgG/IgM) (+) and HDV RNA (+);
- 1×ULN <ALT<10×ULN；
- Patients with hepatitis B eligible to receive treatment with NAs according to current guidelines for the diagnosis and treatment of hepatitis B;
Key exclusion criteria (20 listed)
- Decompensated liver disease: Direct bilirubin > 1.2× ULN, prothrombin time > 1.2× ULN, and serum albumin < 35 g/L;
- Patients with abnormal results of routine hematology test: White blood cell count (WBC) < 3×109/L, neutrophil count < 1.5×109/L and platelet count < 60×109/L;
- Severely decompensated hepatic fiborosis or decompensated cirrhosis: Definitely diagnosed decompensated cirrhosis by imaging examinations such as a Color Doppler ultrasound and CT of the abdomen or clinically diagnosed decompensated cirrhosis by the investigator, or a Metavir fibrosis score of 4 on a liver biopsy sample, or a Child-Pugh score > 7 for liver function assessment;
- Patients who have any of the following conditions:
- Creatinine clearance < 60 mL/min;
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 |
|---|---|---|
| HepalatideAlso: L47Either the placebo or hepalatide (2.1 mg, 4.2 mg, or 6.3 mg) will be given for 4 consecutive weeks. s.c., once daily. | Drug | Hepalatide 2.1mg, Hepalatide 4.2mg, Hepalatide 6.3mg |
| Hepalatide PlaceboAlso: PlaceboEither the placebo or hepalatide (2.1 mg, 4.2 mg, or 6.3 mg) will be given for 4 consecutive weeks. s.c., once daily. | Drug | Placebo 2.1mg/4.2mg/6.3mg |
Primary outcome
Hepatitis D Virus(HDV) RNA level
Time frame: Week 4
HDV RNA level at week4
2 secondary outcomes
Change in Alanine transaminase(ALT) from baseline
Time frame: Week 4
Change in HDV RNA from baseline
Time frame: Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- 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
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hepalatide in people with Chronic Hepatitis D Infection, run by Shanghai HEP Pharmaceutical Co., Ltd. at 3 sites in 2 countries.
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 9 inclusion and 20 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: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China, Mongolia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatitis D Virus(HDV) RNA level (time frame: Week 4). 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 24 Apr 2024.