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Hepatitis B, ChronicPhase 2NCT04426968

A Phase II Study of Hepalatide in Subjects With Chronic Hepatitis B

A Phase 2 study testing Hepalatide 2.1mg, Hepalatide 4.2mg and Hepalatide 6.3mg in people with Hepatitis B, Chronic, run by Shanghai HEP Pharmaceutical Co., Ltd. at 12 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Hepatitis B, Chronic
What is being tested?
Hepalatide 2.1mg, Hepalatide 4.2mg and Hepalatide 6.3mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
12 sitesChina
Study dates
18 Jun 2021to 29 Nov 2023
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age from 18 to 60 years inclusively at the time of signing Informed Consent Form.
  • HBsAg or/and HBV DNA Positive for at least 6 months before Screening.
  • Subjects did not receive interferon treatment and did not receive nucleotide/nucleoside analogue within 6 months
  • HBeAg positive or negative
  • HBV DNA≥20,000 IU/ml (HBeAg positive) or HBV DNA≥2,000 IU/ml (HBeAg negative)
  • 2×ULN ≤ALT≤10×ULN
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  • Serum total bilirubin<2×ULN
  • Subjects had no history of decompensated liver disease（Ascites, jaundice, hepatic encephalopathy, varicose hemorrhage）, serious heart disease (including unstable or uncontrolled heart disease within 6 months),serious mental illness (especially depression),organ transplantation .subjects have no uncontrolled epilepsy, mental illness, diabetes and hypertension,no autoimmune disease, immune related extrahepatic manifestations (vasculitis, purpura, nodular arteritis, peripheral neuropathy and glomerulonephritis), thyroid disease, malignant tumor, immunosuppressive therapy; no basic diseases and other serious diseases such as serious infection, retinal disease, heart failure and chronic obstructive pulmonary disease; no alcohol and drug abuse.
  • Subjects must agree to use a highly effective contraception for 2 years , female subjects are not pregnant or breastfeeding
  • Subjects did not donate blood or as clinical trial subjects within 3 months before screening
  • Subjects have good compliance with the protocol
  • Subjects understood and agreed to sign the informed consent form.

Who cannot join

  • Decompensated liver disease: direct bilirubin > 1.2 × ULN,
  • Prothrombin time > 1.2 × ULN, serum albumin < 35 g / L
  • Severe liver fibrosis or cirrhosis: METAVIR score of liver biopsy is 4 points; or or Child-Pugh score> 7
  • Hemocytopenia: neutrophil < 1 × 10^9 / L, platelet < 50 × 10^9 / L, hemoglobin < 100g / L (female) or hemoglobin < 110g / L (male) points
  • HAV,HCV,HDV,HEV or HIV infection
  • Pegylated interferon therapy is contraindicated
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  • Allergic to interferon, Such as severe depression, epilepsy, autoimmune diseases, uncontrolled thyroid dysfunction and so on
  • severe retinopathy or eye disease(Eye diseases due to high blood pressure or diabetes, CMV retinitis, macular degeneration)
  • Positive for anti-HBV Pre-S1 antibody.
  • Hamilton Depression Scale (HAMD, 17 items) score > 17 points
  • Female subjects pregnancy test positive
  • Other laboratories or auxiliary examinations are obviously abnormal

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • The fifth medical center of PLA

    Beijing, Beijing Municipality, 100039

  • Jilin Hepatobiliary Disease Hospital

    Changchun

  • The first hospital of Jilin University

    Changchun

  • Chizhou People's Hospital

    Chizhou

  • The First Hospital Affiliated to the Army Medical University

    Chongqing

  • The First Affiliated Hospital of Nanchang University

    Nanchang

  • The Second Hospital of Nanjing

    Nanjing

  • Qingyuan People's Hospital

    Qingyuan

  • Shanghai Tongren Hospital

    Shanghai

  • The Sixth People's Hospital of Shenyang

    Shenyang

  • Henan Provincial People's Hospital

    Zhengzhou

  • Henan Provincial Infectious Disease Hospital

    Zhenzhou

Other trials in China

About this study

Official title: 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

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

Read the detailed description

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.

Being tested
Hepalatide 2.1mg, Hepalatide 4.2mg, Hepalatide 6.3mg, placebo 2.1mg, placebo 4.2mg
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.

  • Hepalatide 2.1mgDrug

    Also called L47

    2.1 mg/day subcutaneously (s.c.) for 24 week

  • Hepalatide 4.2mgDrug

    Also called L47

    4.2mg/day subcutaneously (s.c.) for 24 week

  • Hepalatide 6.3mgDrug

    Also called L47

    6.3mg/day subcutaneously (s.c.) for 24 week

  • placebo 2.1mgDrug

    2.1 mg/day subcutaneously (s.c.) for 24 week

  • placebo 4.2mgDrug

    4.2 mg/day subcutaneously (s.c.) for 24 week

  • placebo 6.3mgDrug

    6.3 mg/day subcutaneously (s.c.) for 24 week

  • Pegylated InterferonDrug

    Also called Pegasys

    180 ug/week subcutaneously (s.c.) for 28 week

Study groups in NCT04426968
Study groupRoleWhat they receive
Hepalatide 2.1mg+Pegylated InterferonExperimentalHepalatide 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
Receives: Drug: Hepalatide 2.1mg; Drug: Pegylated Interferon
Hepalatide 4.2mg+Pegylated InterferonExperimentalHepalatide 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
Receives: Drug: Hepalatide 4.2mg; Drug: Pegylated Interferon
Hepalatide 6.3mg+Pegylated InterferonExperimentalHepalatide 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
Receives: Drug: Hepalatide 6.3mg; Drug: Pegylated Interferon
placebo+Pegylated InterferonActive comparatorHepalatide 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
Receives: Drug: placebo 2.1mg; Drug: placebo 4.2mg; Drug: placebo 6.3mg; Drug: Pegylated Interferon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. virological response

    Measured: 24weeks

Secondary outcomes (1)

  1. HBV DNA down from baseline

    HBV DNA down from baseline log10

    Measured: 24weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2020
  2. Study start18 Jun 2021
  3. Primary completion1 Nov 2023
  4. Study completion29 Nov 2023

Resources

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
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04426968
Sponsor's protocol ID
L47-HB-II-02
Status last verified
Dec 2022
First submitted
9 Jun 2020
Last updated
27 Jan 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hepalatide 2.1mg, Hepalatide 4.2mg and Hepalatide 6.3mg in people with Hepatitis B, Chronic, run by Shanghai HEP Pharmaceutical Co., Ltd. at 12 sites 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 12 inclusion and 12 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 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites 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. 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?

virological response (time frame: 24weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04426968.

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 27 Jan 2025.

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