- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07630727
Study of AHB-171 in Chronic Hepatitis B Participants
2. juni 2026 opdateret af: Ausper Biopharma Co., Ltd.
An Open-label Phase II Clinical Study to Evaluate the Efficacy and Safety of AHB-171 Injection in Participants With Chronic Hepatitis B
The study adopts an open-label, multiple-dose design and aims to evaluate the efficacy and safety of AHB-171 Injection after multiple doses in treatment-naïve (HBeAg-negative/positive) and nucleos(t)ide analogue (NA)-treated (HBeAg-negative) participants with chronic hepatitis B (CHB)
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
138
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Bella Lu
- Telefonnummer: 0571-86959519
- E-mail: clinicaltrial@ausperbio.com
Studiesteder
-
-
Jilin
-
Jilin City, Jilin, Kina
- AusperBio Investigational Site
-
Kontakt:
- Bella Lu
- Telefonnummer: 0571-86959519
- E-mail: clinicaltrial@ausperbio.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Able to fully understand and sign the informed consent form (ICF).
- Male or female participants, aged 18-65 years (inclusive).
- Body mass index (BMI) meeting the predefined eligibility range.
- Chronic hepatitis B (CHB) participants with HBsAg or HBV DNA positivity for ≥6 months at screening.
- At screening, participants meeting predefined ranges of HBsAg, HBV DNA, and ALT according to prior nucleos(t)ide analogue (NA) treatment history (stable prior treatment or treatment-naive), and meeting corresponding prior antiviral treatment duration requirements.
- Adopt effective contraceptive measures as required
Exclusion Criteria:
- History of any severe systemic disease or malignancy other than chronic HBV infection which, in the opinion of the investigator, makes the subject unsuitable for study participation.
- Prior history of solid organ or hematopoietic stem cell transplantation.
- History of any other liver disease that the investigator considers unsuitable for trial.History of autoimmune disease or diseases with potential immune activation risk.
- History or presence of hepatic decompensation at screening.
- History of primary liver cancer, or diagnosis/suspected liver cancer at screening.
- Imaging or histological evidence of significant liver fibrosis or cirrhosis within 12 months prior to screening, or a liver stiffness measurement indicative of significant fibrosis or cirrhosis at screening. Major trauma or major surgery within 12 weeks prior to screening
- History of severe allergies (e.g., to ≥2 allergens) or severe allergy to any component of the study drug, or in the opinion of the investigator, makes the subject unsuitable for participation.
- Severe infection requiring intravenous anti-infective therapy within 2 weeks prior to screening (excluding chronic HBV infection).
- History of drug abuse, or alcoholism.
- Blood donation or blood loss exceeding the specified volume within 12 weeks prior to screening, or planned blood donation during the trial period.
- Use of immunosuppressants, immunomodulators, cytotoxic drugs, or biologics within 6 months prior to screening.
- Use of any oligonucleotide drugs or interferon therapy within 12 months prior to screening.
- Vaccination within 4 weeks prior to screening, or planned vaccination during the trial period.
- Presence of tattoos, active skin diseases, or other conditions that may interfere with subcutaneous drug administration or observation of injection site reactions.
- Clinically significant abnormal electrocardiogram (ECG) at screening.
- Tested positive for HIV,HCV or active syphilis infection.
- Uncontrolled hypertension at screening.
- Clinically significant abnormal laboratory test as specified in protocol at screening.
- Currently participating in another clinical trials, or within the washout period.
- Any other condition or factor which, in the opinion of the investigator, makes the subject unsuitable for trial participation.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: AHB-171 in Treatment CHB
|
Subcutaneous injection
|
|
Eksperimentel: AHB-171 in Naïve CHB
|
Subcutaneous injection
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Proportion of participants with HBsAg <10 IU/mL and HBV DNA < LLOQ (10 IU/mL)
Tidsramme: Up to 90 days
|
Up to 90 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ)
Tidsramme: Up to 90 days
|
Up to 90 days
|
|
|
Reduction of HBsAg (log₁₀ IU/mL) from baseline and maximum reduction at each visit
Tidsramme: Up to 90 days
|
Up to 90 days
|
|
|
Proportion of participants with HBsAg decline from baseline of <0.5, ≥0.5, ≥1.0, ≥1.5, ≥2.0, ≥3.0 log₁₀ IU/mL at each visi
Tidsramme: Up to 90 days
|
Up to 90 days
|
|
|
Proportion of participants with HBsAg <100 IU/mL, <10 IU/mL, <1 IU/mL at each visit
Tidsramme: Up to 90 days
|
Up to 90 days
|
|
|
Proportion of participants achieving HBsAg clearance (HBsAg <0.05 IU/mL) at each visit
Tidsramme: Up to 90 days
|
Up to 90 days
|
|
|
Proportion of participants with HBV DNA < LLOQ (10 IU/mL) at each visit
Tidsramme: Up to 90 days
|
Up to 90 days
|
|
|
Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ) at each visit
Tidsramme: Up to 90 days
|
Up to 90 days
|
|
|
Proportion of participants with anti-HBs seroconversion (HBsAg clearance and HBsAb >10 IU/L) at each visit
Tidsramme: Up to 90 days
|
Up to 90 days
|
|
|
Absolute or log change from baseline for HBsAg at each visit
Tidsramme: Up to 90 days
|
Up to 90 days
|
|
|
Absolute or log change from baseline for HBV RNA at each visit
Tidsramme: Up to 90 days
|
Up to 90 days
|
|
|
Absolute or log change from baseline for HBcrAg at each visit
Tidsramme: Up to 90 days
|
Up to 90 days
|
|
|
Absolute or log change from baseline for HBeAg at each visit
Tidsramme: Up to 90 days
|
Up to 90 days
|
|
|
Absolute or log change from baseline for HBeAb at each visit
Tidsramme: Up to 90 days
|
Up to 90 days
|
|
|
Proportion of participants with baseline ALT > ULN achieving ALT normalization, and time to ALT normalization
Tidsramme: Up to 90 days
|
Up to 90 days
|
|
|
Incidence and severity of treatment-emergent adverse events (TEAE) and serious adverse events (SAE)
Tidsramme: Up to 90 days
|
CTCAE will be used to describe severity.
|
Up to 90 days
|
|
Proportion of participants with clinically significant abnormalities in laboratory tests
Tidsramme: Up to 90 days
|
Up to 90 days
|
|
|
Proportion of participants with clinically significant abnormalities in ECG
Tidsramme: Up to 90 days
|
Up to 90 days
|
|
|
Proportion of participants with clinically significant abnormalities in physical examinations and vital signs
Tidsramme: Up to 90 days
|
Up to 90 days
|
|
|
Changes in ECG from baseline
Tidsramme: Up to 90 days
|
Up to 90 days
|
|
|
Proportion of participants with HBsAg decline ≥2.0 log₁₀ IU/mL
Tidsramme: Up to 90 days
|
Up to 90 days
|
|
|
Plasma concentration of AHB-171 at different time points
Tidsramme: Up to 90 days
|
Up to 90 days
|
|
|
Proportion of participants with detectable anti-drug antibody (ADA)
Tidsramme: Up to 90 days
|
Up to 90 days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
15. juli 2026
Primær færdiggørelse (Anslået)
31. marts 2029
Studieafslutning (Anslået)
31. maj 2029
Datoer for studieregistrering
Først indsendt
2. juni 2026
Først indsendt, der opfyldte QC-kriterier
2. juni 2026
Først opslået (Faktiske)
5. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Blodbårne infektioner
- Organisering af lungebetændelse
- Sygdomme i immunsystemet
- Infektioner
- Virussygdomme
- Luftvejssygdomme
- Sygdomme i fordøjelsessystemet
- Lungesygdomme
- Bronchiale sygdomme
- Lungesygdomme, obstruktiv
- Leversygdomme
- Hepatitis, viral, menneskelig
- Overførbare sygdomme
- DNA-virusinfektioner
- Hepadnaviridae infektioner
- Bronchiolitis Obliterans
- Bronchiolitis
- Bronkitis
- Hepatitis
- Graft vs værtssygdom
- Bronchiolitis Obliterans syndrom
- Hepatitis B
Andre undersøgelses-id-numre
- AB-17-8003
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Hepatitis B, kronisk (CHB)
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Merck Sharp & Dohme LLCAfsluttet
-
First Affiliated Hospital Xi'an Jiaotong UniversityRekrutteringHepatitis B | Hepatitis B-virus (HBV) | Hepatitis B, kronisk (CHB)Kina
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The Affiliated Nanjing Drum Tower Hospital of Nanjing...Gilead SciencesIkke rekrutterer endnu
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Tam Anh Research InstituteAktiv, ikke rekrutterendeKronisk hepatitis b | Hepatitis Delta med Hepatitis B Carrier StateVietnam
-
Tongji HospitalChia Tai Tianqing Pharmaceutical Group Co., Ltd.UkendtKronisk hepatitis b
-
Nanfang Hospital of Southern Medical UniversityRekruttering
-
IlDong Pharmaceutical Co LtdRekrutteringKronisk hepatitis bKorea, Republikken
-
Antios Therapeutics, IncAfsluttetKronisk hepatitis bForenede Stater
-
Xi'an Xintong Pharmaceutical Research Co.,Ltd.Ukendt
-
Third Affiliated Hospital, Sun Yat-Sen UniversityRekrutteringKronisk hepatitis b | Cirrhose på grund af hepatitis BKina
Kliniske forsøg med AHB-171 Injection
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Ausper Biopharma Co., Ltd.RekrutteringKronisk hepatitis B-infektionKina
-
Ausper Biopharma Co., Ltd.Aktiv, ikke rekrutterende
-
Ausper Biopharma Co., Ltd.Rekruttering
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AusperBio Therapeutics Inc.RekrutteringHepatitis B, kroniskTaiwan, New Zealand, Australien, Sydkorea, Singapore, Kina
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AusperBio Therapeutics Inc.AfsluttetKronisk hepatitis BForenede Stater, Hong Kong, Taiwan, New Zealand
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Ausper Biopharma Co., Ltd.Afsluttet
-
Ausper Biopharma Co., Ltd.Aktiv, ikke rekrutterende
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Gramercy Research GroupPatient-Centered Outcomes Research Institute; Vanderbilt University; University... og andre samarbejdspartnereUkendtForhøjet blodtryk | Fedme | Diabetes | Kronisk sygdom | Medicinadhærens | SelvplejeForenede Stater
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Ausper Biopharma Co., Ltd.Aktiv, ikke rekrutterende
-
ArQule, Inc. (a wholly owned subsidiary of Merck...Afsluttet