- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07635186
A Study to Evaluate AHB-137 Injection in Treatment-naïve Participants With Chronic Hepatitis B
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Clinical Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Treatment-naïve Participants With Chronic Hepatitis B.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Lu
- Telefonnummer: 0571-86959519
- E-mail: clinicaltrial@ausperbio.com
Studiesteder
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Kina
- The Second Affiliated Hospital of Chongqing Medical University
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Zhejiang
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Hangzhou, Zhejiang, Kina
- The First Affiliated Hospital of Zhejiang University School of Medicine
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Volunteer to participate and sign the informed consent form, and are willing to complete the study in accordance with the requirements of the protocol.
- Aged 18-65 years (including boundary values).
- Body mass index between the range of 18-32 kg/m2 (inclusive boundary values).
- HBsAg or HBV DNA positive for ≥ 6 months at screening and no antiviral treatment with interferon or nucleoside analogue.
- HBsAg and HBV DNA values met protocol requirements at screening.
- ALT < 3xULN at screening.
- Use highly effective contraception as required.
Exclusion Criteria:
- Uncontrolled and stable clinically significant abnormalities other than a history of chronic HBV infection.
- Participants with other clinically significant liver diseases, previous/current manifestations of hepatic decompensation, and a history of extrahepatic diseases that may be related to HBV immune status.
- Any serious infection other than chronic hepatitis B infection requiring intravenous anti-infective therapy within 1 month prior to randomization.
- Hepatitis C virus (HCV) infection or < 12 months from cure at screening (HCV RNA positive within 12 months), human immunodeficiency virus (HIV) positive at screening, and syphilis positive (treponema pallidum antibody positive).
- Significant fibrosis or cirrhosis, or liver stiffness value (LSM) > 9.0 kPa at screening.
- Participants with confirmed or suspected liver cancer who have a history of malignancy within the past 5 years or are undergoing assessment for a possible malignancy.
- Laboratory test results do not meet the criteria.
- Prior/current autoimmune disease, history of vasculitis, or presence of signs, symptoms, or laboratory tests of underlying vasculitis.
- Fridericia ' s formula corrected QT interval (QTcF) ≥ 450 msec for male participants and ≥ 470 msec for female participants at screening.
- Allergic to AHB-137 ingredients, or history of drug allergy or other allergies.
- Major trauma or major surgery within 3 months prior to screening, or planned surgery during the trial.
- Participants are participating in another clinical trial or failing to wash out as required.
- Current use or use of any immunosuppressive medication (e.g. prednisone) within 3 months prior to screening, except for short courses (≤ 2 weeks) or use of topical/inhaled steroids;Those who have used immunomodulators within 3 months prior to screening;Those who have used cytotoxic drugs within 6 months prior to screening;History of vaccination within 1 month prior to screening or a live vaccination plan during the trial.
- Participants that require regular long-term anticoagulants.
- Abnormal thyroid function.
- Participants that have received any antisense oligonucleic acid, siRNA, capsid assembly modulator (CAM) antiviral drug used to treat chronic hepatitis B.
- Any other circumstances or conditions in which, in the opinion of the investigator, the participant is inappropriate for participation in this trial.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: AHB-137
AHB-137 will be administered subcutaneously.
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AHB-137 will be administered subcutaneously.
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Placebo komparator: Placebo
Placebo will be administered subcutaneously.
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Placebo vil blive indgivet subkutant.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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HBV DNA < lower limit of quantitation (LLOQ), 10 IU/mL, HBsAg < limit of detection (LOD), 0.05 IU/mL with or without hepatitis B virus surface antibody (HBsAb) 24 weeks after discontinuation of all chronic hepatitis B treatment.
Tidsramme: Up to 48 weeks.
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Up to 48 weeks.
|
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Highly sensitive HBsAg < 0.005 IU/mL and HBV DNA < LLOQ (10 IU/mL) at the end of treatment.
Tidsramme: Up to 48 weeks.
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Up to 48 weeks.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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HBV DNA < LLOQ, 10 IU/mL, and HBsAg < 10 IU/mL 24 weeks after discontinuation of all chronic hepatitis B treatment.
Tidsramme: Up to 48 weeks.
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Up to 48 weeks.
|
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HBV DNA < LLOQ 24 weeks after discontinuation of all chronic hepatitis B treatment.
Tidsramme: Up to 48 weeks.
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Up to 48 weeks.
|
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HBV DNA < LLOQ and HBsAg < 100 IU/mL 24 weeks after discontinuation of all chronic hepatitis B treatment.
Tidsramme: Up to 48 weeks.
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Up to 48 weeks.
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HBsAg seroconversion rate 24 weeks after discontinuation of all chronic hepatitis B treatment.
Tidsramme: Up to 48 weeks.
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HBsAg seroconversion : serum HBsAg<LOD, and at the same time or subsequently, HBsAb>10 IU/L.
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Up to 48 weeks.
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HBeAg seroconversion rate 24 weeks after discontinuation of all chronic hepatitis B treatment.
Tidsramme: Up to 48 weeks.
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HBeAg seroconversion:HBeAg negative, with simultaneous or subsequent positivity for HBeAb.
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Up to 48 weeks.
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Proportion of participants who discontinued all chronic hepatitis B treatment at the end of treatment.
Tidsramme: Up to 48 weeks.
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Up to 48 weeks.
|
|
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HBV DNA < LLOQ and HBsAg < LOD rate and HBV DNA < LLOQ and HBsAg < 10 IU/mL rate by visit.
Tidsramme: Up to 48 weeks.
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Up to 48 weeks.
|
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HBsAg, HBeAg seroconversion rates by visit.
Tidsramme: Up to 48 weeks.
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HBsAg seroconversion: serum HBsAg<LOD, and at the same time or subsequently, HBsAb>10 IU/L. HBeAg seroconversion: HBeAg negative, with simultaneous or subsequent positivity for HBeAb. |
Up to 48 weeks.
|
|
Test Values of Virological Parameters.
Tidsramme: Up to 48 weeks.
|
HBsAb, HBsAg, HBV DNA values and changes from baseline at each visit.
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Up to 48 weeks.
|
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Time to first achievement of HBsAg and first HBeAg seroconversion.
Tidsramme: Up to 48 weeks.
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HBsAg seroconversion: serum HBsAg<LOD, and at the same time or subsequently, HBsAb>10 IU/L. HBeAg seroconversion: HBeAg negative, with simultaneous or subsequent positivity for HBeAb. |
Up to 48 weeks.
|
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Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline.
Tidsramme: Up to 48 weeks.
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Response options range from 1 to 5 with higher scores indicating more severe impact .
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Up to 48 weeks.
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Changes of the score of EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) in participants compared with baseline.
Tidsramme: Up to 48 weeks.
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The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions.
This decision results in a 1-digit number that expresses the level selected for that dimension.
The digits for the five dimensions can be combined into a 5-digit number that describes the participant's health state.
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Up to 48 weeks.
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Proportion of participants with protocol-defined virologic response for HBsAg and HBV DNA.
Tidsramme: Up to 48 weeks.
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Up to 48 weeks.
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Change from baseline in alanine aminotransferase (ALT) and noninvasive assessment of liver fibrosis at each visit.
Tidsramme: Up to 48 weeks.
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Up to 48 weeks.
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Time to normalization of ALT without rescue therapy (for participants with abnormal baseline ALT).
Tidsramme: Up to 48 weeks.
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Up to 48 weeks.
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AHB-137 resistance analysis.
Tidsramme: Up to 48 weeks.
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Method: Sequencing of HBV DNA/RNA.
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Up to 48 weeks.
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Proportion of participants who are HBeAb positive and HBeAg negative, and the test values of HBsAb, HBsAg and HBV DNA meet certain conditions.
Tidsramme: Up to 48 weeks.
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Up to 48 weeks.
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Safety: number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results.
Tidsramme: Up to 48 weeks.
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Examination including laboratory examination, electrocardiogram (ECG) examination.
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Up to 48 weeks.
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Proportion of participants with positive anti-drug antibody (ADA) and ADA level at each visit.
Tidsramme: Up to 48 weeks.
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Up to 48 weeks.
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Plasma drug concentration of AHB-137.
Tidsramme: Up to 48 weeks.
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Up to 48 weeks.
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Peng Hu, The Second Affiliated Hospital of Chongqing Medical University
- Ledende efterforsker: Yunqing Qiu, Zhejiang University
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Blodbårne infektioner
- Patologiske processer
- Kronisk sygdom
- Sygdomsegenskaber
- Infektioner
- Virussygdomme
- Sygdomme i fordøjelsessystemet
- Leversygdomme
- Hepatitis, viral, menneskelig
- Overførbare sygdomme
- DNA-virusinfektioner
- Hepadnaviridae infektioner
- Hepatitis, kronisk
- Hepatitis
- Patologiske tilstande, tegn og symptomer
- Hepatitis B
- Hepatitis B, kronisk
Andre undersøgelses-id-numre
- AB-10-8016
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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