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Chronic Hepatitis BPhase 2NCT05244057

A Study of Hepalatide Combined With TAF and PEG-IFN as Finite Treatment of Chronic Hepatitis B Patients

A Phase 2 study testing Hepalatide, Tenofovir Alafenamide Tablets and Pegylated Interferon alfa 2a in people with Chronic Hepatitis B, run by Shanghai HEP Pharmaceutical Co., Ltd. at 1 site 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

The study is designed to assess efficacy of a finitie treatment in Chronic Hepatitis B patients who had stable treatment of NAs for ≧ 2 years， which is compared hepalatide in combination with Pegylated Interferon + TAF with Pegylated Interferon +TAF. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Chronic Hepatitis B
What is being tested?
Hepalatide, Tenofovir Alafenamide Tablets and Pegylated Interferon alfa 2a
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8 participants
Where
1 siteChina
Study dates
23 Aug 2022to 24 Jun 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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 1. HBsAg or/and HBV DNA Positive for at least 6 months
  • 2. HBeAg negative
  • 3. Received NAs stabilization therapy for at least 2 years
  • 4. ALT≤ 2×ULN
  • 5. HBV DNA< LLQD(lower limit of quantitative detection) in Screening
  • 6. Serum total bilirubin<2×ULN
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  • 7. no childbirth plan within 2 years and agree to take effective contraceptive measures throughout the treatment period and within 3 months after the last dose, and that the woman is not pregnant or breastfeeding.
  • 8. have not participant in another clinical trial within 3 months before screening
  • 9. Subjects have good compliance with the protocol
  • 10. Subjects understood and agreed to sign the informed consent form.

Who cannot join

  • 1. Contraindications of Peginterferon such as depressive disorder, epilepsy, autoimmune diseases, uncontrolled thyroid dysfunction, etc
  • 2. Subjects with cirrhosis, e.g., definite cirrhosis on imaging such as abdominal ultrasound and CT; liver biopsy with Metavir fibrosis score = 4; clinical diagnosis of cirrhosis by the investigator.
  • 3. Decompensated liver disease
  • 4. Child-Pugh score of B-C or over 6 points.
  • 5. Subjects with any of the following circumstances
  • History of decompensated liver disease
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  • History of serious heart disease (including unstable or uncontrolled heart disease within 6 months)
  • Uncontrolled seizures, severe psychiatric disorders, or a history of psychiatric disorders
  • with history of organ transplantation
  • with poorly controlled diabetes and hypertension
  • with autoimmune diseases, immune-related extrahepatic manifestations, thyroid disease, malignant tumors, or in immunosuppressive therapy
  • underlying diseases such as malignant tumor, severe infection, heart failure and chronic obstructive pulmonary disease and other serious diseases.
  • with history of alcohol or drug abuse
  • 6. Creatinine clearance <60 mL/min.
  • 7. HAV, HCV, HDV, HEV or HIV co-infection
  • 8. Subjects who must be treated with Nucleosides (acids) other than TAF during treatment period
  • 9. Subjects who used interferon in the 6 months prior to the screening period
  • 10. Positive for anti-HBV Pre-S1 antibody.
  • 11. Hemocytopenia: White blood cells < 3 × 10^9 / L, neutrophil < 1.5 × 10^9 / L, platelet < 60 × 10^9 / L,
  • 12. Female subjects pregnancy test positive
  • 13. known to be allergic to the investigational drug or the underlying treatment drug
  • 14. Other laboratories or auxiliary examinations are obviously abnormal

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Tong Ren Hospital

    Shanghai, Shanghai Municipality, 200050

Other trials in China

About this study

Official title: A Phase II of Randomized, Double-blind, Placebo-controlled, Multi-center Study of Hepalatide for Injection Combined With Pegylated Interferon and TAF as Finite Treatment in Chronic Hepatitis B Patients

The study is designed to assess efficacy of a finitie treatment in Chronic Hepatitis B patients who had stable treatment of NAs for ≧ 2 years， which is compared hepalatide in combination with Pegylated Interferon + TAF with Pegylated Interferon +TAF. Subjects will be randomly assigned to the hepalatide or placebo groups , 15 subjects in each group . Subjects will receive hepalatide+Pegylated Interferon +TAF treatment for 48 weeks or placebo +PegylatedInterferon +TAF treatment for 48 weeks , Then, stopping hepalatide and Pegylate Interferon treatments and followed with further 8 weeks follow-up.

Read the detailed description

Hepalatide is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic hepatitis B virus (HBV) infection. The aim of this study is to assess efficacy of a finitie treantment , that combination regimen of hepalatide+half dose Pegylated interferon + TAF , as measured by the primary efficacy endpoint. This study will be conducted in 3 periods: Screening Period (4weeks), Treatment Period (48 weeks) and Follow-up (FU) Period (8 weeks). Safety assessments will include adverse events (AEs), serious AEs, clinical safety laboratory tests, electrocardiograms (ECGs), vital signs, ophthalmologic examinations and physical examinations. Total duration of individual participation will be up to 60 weeks (including screening period).

Being tested
Hepalatide, Placebo of Hepalatide, Tenofovir Alafenamide Tablets, Pegylated Interferon alfa 2a
Keywords
hepalatide, Hepatitis B，finite treatment,
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.

  • HepalatideDrug

    Also called L47

    6.3mg, s.c., qd for 48 weeks

  • Placebo of HepalatideDrug

    Also called Placebo

    s.c., qd for 48 weeks

  • Tenofovir Alafenamide TabletsDrug

    Also called Vemlidy

    25mg, p.o., qd for 48 weeks

  • Pegylated Interferon alfa 2aDrug

    Also called Pegasys

    90ug, s.c., qw for 48 weeks

Study groups in NCT05244057
Study groupRoleWhat they receive
Hepalatide + TAF + PEG-IFNExperimentalPatients will receive 6.3mg Hepalatide +25mg Tenofovir alafenamide+ 90ug Pegylated Interferon for 48 weeks with a further follow-up period of 24 weeks.
Receives: Drug: Hepalatide; Drug: Tenofovir Alafenamide Tablets; Drug: Pegylated Interferon alfa 2a
Placebo+ TAF + PEG-IFNPlacebo comparatorPatients will receive Placebo +25mg Tenofovir alafenamide + 90ug Pegylated Interferon for 48 weeks with a further follow-up period of 24 weeks.
Receives: Drug: Placebo of Hepalatide; Drug: Tenofovir Alafenamide Tablets; Drug: Pegylated Interferon alfa 2a

What is being measured

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

  1. Proportion of subjects with negative conversion of HBsAg

    Proportion of subjects with negative conversion of HBsAg treatment at 8 weeks off treatment

    Measured: 56 Weeks

Secondary outcomes (5)

  1. Number of subjects with virological relapse(VR) at 8 weeks off treatment

    VR: reappearance of HBV DNA > 2000 IU/ml from undetectable status

    Measured: 56 Weeks

  2. Number of subjects with clinical relapse(CR) at 8 weeks off treatment

    CR: the presence of VR with the elevation of alanine transaminase (ALT) more than two times upper limit of normal (ULN)

    Measured: 56 Weeks

  3. HBsAg is down from baseline at 8 weeks off treatment

    HBsAg is down from baseline log10

    Measured: 56 Weeks

  4. Number of subjects with Serological conversion of HBsAg

    Number of subjects with Serological conversion of HBsAg at 8 weeks off treatment

    Measured: 56 Weeks

  5. Change in liver stiffness at 8 weeks off treatment

    The findings of Liver stiffness measurement(LSM) of Fibroscan/FibroTouch at week 8 off treatment compared to baseline

    Measured: 56 Weeks

Timeline

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

  1. First posted17 Feb 2022
  2. Study start23 Aug 2022
  3. Primary completion24 Jun 2024
  4. Study completion24 Jun 2024

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05244057
Sponsor's protocol ID
L47-HB-FIN-1(New Finite)
Status last verified
Dec 2023
First submitted
3 Feb 2022
Last updated
15 Jul 2024
Results posted
No
Data monitoring committee
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, Tenofovir Alafenamide Tablets and Pegylated Interferon alfa 2a in people with Chronic Hepatitis B, run by Shanghai HEP Pharmaceutical Co., Ltd. at 1 site 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 10 inclusion and 22 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 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

Proportion of subjects with negative conversion of HBsAg (time frame: 56 Weeks). 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 NCT05244057.

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 15 Jul 2024.

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