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Chronic HBV InfectionPhase 3NCT03903796

Study of the Efficacy and Safety of HS-10234 in Patients With Chronic Hepatitis B Virus Infection

A Phase 3 study testing HS-10234 and TDF in people with Chronic HBV Infection, run by Jiangsu Hansoh 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 primary objective of this study is to compare the safety and efficacy of HS-10234 versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with chronic hepatitis B virus (HBV) infection. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic HBV Infection
What is being tested?
HS-10234 and TDF
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
963 participants
Where
1 siteChina
Study dates
16 Aug 2018to 7 Jun 2024
Phase
Phase 3
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

  • Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
  • Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study screening.
  • Male and non-pregnant, non-lactating females, from 18 up to 65 years of age (based on the date of the screening visit). A negative serum pregnancy test at screening is required for female subjects of childbearing potential.
  • Documented evidence of chronic HBV infection (e.g. HBsAg positive for more than 6 months).
  • HBeAg-positive or HBeAg-negative chronic hepatitis B with all of the following: HBV DNA ≥ 2 x 104 IU/mL; Screening serum 1 ULN < ALT level ≤ 10 ULN.
  • Treatment-naive subjects (defined as < 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue) OR treatment-experienced subjects (defined as subjects meeting all entry criteria [including HBV DNA and serum ALT criteria] and with ≥ 12 weeks of previous treatment with any nucleoside or nucleotide analogue) will be eligible for enrollment. Treatment-experienced subjects receiving oral antiviral treatment at Screening must continue their treatment regimen until the time of randomization, when it will be discontinued.
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  • Any previous treatment with interferon (pegylated or non-pegylated) must have ended at least 6 months prior to the baseline visit.
  • Estimated creatinine clearance (CLcr) ≥ 50 mL/min（using the Cockcroft-Gault method）based on serum creatinine and actual body weight as measured at the screening evaluation, as follows:
  • （140-age in years）(body weight [kg]) (72)(serum creatinine [mg/dL]） 8) Normal ECG (or if abnormal, determined by the Investigator not to be clinically significant).
  • 9) Must be willing and able to comply with all study requirements.

Who cannot join

  • Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:
  • Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study.
  • Males and females of reproductive potential who are unwilling to use an "effective", protocol specified method(s) of contraception during the study.
  • Co-infection with HCV virus, HIV, or HDV.
  • Evidence of hepatocellular carcinoma (e.g. as evidenced by recent imaging).
  • Any history of, or current evidence of, clinical hepatic decompensation (e.g. ascites encephalopathy or variceal hemorrhage).
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  • Abnormal hematological and biochemical parameters, including:
  • Hemoglobin < 10 g/dl
  • Absolute neutrophil count < 0.75 × 109/L
  • Platelets ≤ 50 × 109/L
  • AST or ALT > 10 × ULN
  • Total Bilirubin > 2.5 × ULN
  • Albumin < 3.0 g/dL
  • INR > 1.5 × ULN (unless stable on anticoagulant regimen)
  • Received solid organ or bone marrow transplant.
  • Significant renal, cardiovascular, pulmonary, or neurological disease in the opinion of the investigator.
  • Significant bone disease (e.g. osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochrondroses), or multiple bone fractures.
  • Malignancy within the 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc).
  • Currently receiving therapy with immunomodulators (e.g. corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion.
  • Known hypersensitivity to study drugs, metabolites, or formulation excipients.
  • Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance.
  • Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements.
  • Subjects on prohibited concomitant medications. Subjects on prohibited medications, otherwise eligible, will need a wash out period of at least 30 days.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Hospital of Jilin University

    Changchun, Jilin

Other trials in China

About this study

Official title: A Phase 3, Randomized, Multicenter, Double-blind, Double-dummy, Parallel-controlled Study to Evaluate the Safety and Efficacy of HS-10234 25 mg QD Versus TDF 300 mg QD for the Treatment of Patients With HBeAg+/- Chronic HBV Infection.

The primary objective of this study is to compare the safety and efficacy of HS-10234 versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with chronic hepatitis B virus (HBV) infection.

Read the detailed description

This is a phase 3, randomized, multicenter, double-blind, double-dummy, parallel-controlled, non-inferiority trial to evaluate the safety and efficacy of HS-10234 25 mg qd versus TDF 300 mg qd. Patients with chronic HBV infection who are positive or negative for the hepatitis B e antigen (HBeAg) will be randomly assigned (2:1) to receive either 25 mg HS-10234 or 300 mg TDF with matching placebo. Randomization will be done by a computer-generated allocation sequence stratified by plasma HBV DNA concentration (HBV DNA< 8 log10IU/mL；HBV DNA ≥8 log10IU/mL) and previous treatment experience (treatment-naive and treatment-experienced). All patients will receive 144 weeks of antiviral therapy. After 96 weeks of double-blind treatment, all subjects will be eligible to receive open-label HS-10234 until 144 weeks.

The primary efficacy endpoint is the proportion of patients with HBV DNA less than 20 IU/mL at week 48 in all patients who are randomly assigned and received at least one dose of study drug using a missing-equals-failed approach. Key pre-specified safety endpoints are bone and renal parameters at week 48. Other pre-specified endpoints include viral suppression, serologic response, normalization of alanine aminotransferase (ALT) levels and the emergence of resistance mutations at week 48, 96 and 144.

Being tested
HS-10234, TDF
Keywords
HBeAg-positive or negative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HS-10234Drug

    Drug: HS-10234 HS-10234 25mg will administer orally once daily Drug: TDF placebo TDF placebo 300mg will administer orally once daily

  • TDFDrug

    Drug: TDF TDF 300mg will administer orally once daily Drug: HS-10234 placebo HS-10234 placebo 25mg will administer orally once daily

Study groups in NCT03903796
Study groupRoleWhat they receive
HS-10234 25mgExperimentalHS-10234 + TDF placebo for up to 96 weeks
Receives: Drug: HS-10234; Drug: TDF
TDF 300mgActive comparatorTDF + HS-10234 placebo for up to 96 weeks
Receives: Drug: HS-10234; Drug: TDF
Open-label HS-10234ExperimentalAll participants who complete the double-blind period (96 weeks) will be eligible to receive open-label HS-10234 until week 144 of the study.
Receives: Drug: HS-10234

What is being measured

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

  1. Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA < 20 IU/mL

    The primary efficacy endpoint was the proportion of patients with HBV DNA < 20 IU/mL at week 48 in all patients who are randomly assigned and received HS-10234 25 mg or TDF 300 mg. The safety and tolerance were also observed in two treatment groups.

    Measured: Week 48

Secondary outcomes (3)

  1. Evaluation the percent Change from Baseline in Hip BMD

    Percent Change from Baseline in Hip Bone Mineral Density (BMD) at Week 48

    Measured: Week 48

  2. Evaluation the percent Change from Baseline in Spine BMD

    Percent Change from Baseline in Spine BMD at Week 48

    Measured: Week 48

  3. Evaluation the change from Baseline in Serum Creatinine

    Change from Baseline in Serum Creatinine at Week 48

    Measured: Week 48

Timeline

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

  1. First posted4 Apr 2019
  2. Study start16 Aug 2018
  3. Primary completion31 May 2020
  4. Study completion7 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
963 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03903796
Sponsor's protocol ID
HS-10234-301
Status last verified
Dec 2024
First submitted
3 Mar 2019
Last updated
17 Dec 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Liu ZH, Jin QL, Zhang YX, Gong GZ, Wu GC, Yao LF, Wen XF, Gao ZL, Huang Y, Yang DK, Chen EQ, Mao Q, Lin SD, Shang J, Gong HY, Zhong LH, Yin HF, Wang FM, Hu P, Zhang XQ, Gao QJ, Xia P, Li C, Niu JQ, Hou JL; TMF Study Group. [Safety profile of tenofovir amibufenamide therapy extension or switching in patients with chronic hepatitis B: a phase Ⅲ multicenter, randomized controlled trial]. Zhonghua Gan Zang Bing Za Zhi. 2024 Oct 20;32(10):893-903. doi: 10.3760/cma.j.cn501113-20240807-00366. Chinese.

    PubMed 39528324

  • Liu ZH, Jin QL, Zhang YX, Gong GZ, Wu GC, Yao LF, Wen XF, Gao ZL, Huang Y, Yang DK, Chen EQ, Mao Q, Lin SD, Shang J, Gong HY, Zhong LH, Yin HF, Wang FM, Hu P, Zhang XQ, Gao QJ, Jin CN, Li C, Niu JQ, Hou JL; TMF Study Group. [Efficacy evaluation of extending or switching to tenofovir amibufenamide in patients with chronic hepatitis B: a phase Ⅲ randomized controlled study]. Zhonghua Gan Zang Bing Za Zhi. 2024 Oct 20;32(10):883-892. doi: 10.3760/cma.j.cn501113-20240807-00365. Chinese.

    PubMed 39528323

  • Liu Z, Jin Q, Zhang Y, Gong G, Wu G, Yao L, Wen X, Gao Z, Huang Y, Yang D, Chen E, Mao Q, Lin S, Shang J, Gong H, Zhong L, Yin H, Wang F, Hu P, Wu Q, Pan C, Jia W, Li C, Sun C, Niu J, Hou J; TMF Study Group. 96-Week Treatment of Tenofovir Amibufenamide and Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients. J Clin Transl Hepatol. 2023 Jun 28;11(3):649-660. doi: 10.14218/JCTH.2022.00058. Epub 2022 Nov 1.

    PubMed 36969889

  • Liu Z, Jin Q, Zhang Y, Gong G, Wu G, Yao L, Wen X, Gao Z, Huang Y, Yang D, Chen E, Mao Q, Lin S, Shang J, Gong H, Zhong L, Yin H, Wang F, Hu P, Xiao L, Li C, Wu Q, Sun C, Niu J, Hou J; TMF Study Group. Randomised clinical trial: 48 weeks of treatment with tenofovir amibufenamide versus tenofovir disoproxil fumarate for patients with chronic hepatitis B. Aliment Pharmacol Ther. 2021 Nov;54(9):1134-1149. doi: 10.1111/apt.16611. Epub 2021 Sep 29.

    PubMed 34587302

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HS-10234 and TDF in people with Chronic HBV Infection, run by Jiangsu Hansoh 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 23 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 17 Dec 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA < 20 IU/mL (time frame: Week 48). 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 NCT03903796, which also lists 4 linked publications.

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 17 Dec 2024.

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