- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 2
Contatti e Sedi
Contatto studio
- Nome: Lu
- Numero di telefono: 0571-86959519
- Email: clinicaltrial@ausperbio.com
Luoghi di studio
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Cina
- The Second Affiliated Hospital of Chongqing Medical University
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Zhejiang
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Hangzhou, Zhejiang, Cina
- The First Affiliated Hospital of Zhejiang University School of Medicine
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: AHB-137
AHB-137 will be administered subcutaneously.
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AHB-137 will be administered subcutaneously.
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Comparatore placebo: Placebo
Placebo will be administered subcutaneously.
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Il placebo verrà somministrato per via sottocutanea.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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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.
Lasso di tempo: 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.
Lasso di tempo: Up to 48 weeks.
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Up to 48 weeks.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: Up to 48 weeks.
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Up to 48 weeks.
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HBsAg, HBeAg seroconversion rates by visit.
Lasso di tempo: 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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Test Values of Virological Parameters.
Lasso di tempo: Up to 48 weeks.
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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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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).
Lasso di tempo: Up to 48 weeks.
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Up to 48 weeks.
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AHB-137 resistance analysis.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: Up to 48 weeks.
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Up to 48 weeks.
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Plasma drug concentration of AHB-137.
Lasso di tempo: Up to 48 weeks.
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Up to 48 weeks.
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Peng Hu, The Second Affiliated Hospital of Chongqing Medical University
- Investigatore principale: Yunqing Qiu, Zhejiang University
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Infezioni a trasmissione ematica
- Processi patologici
- Malattia cronica
- Attributi della malattia
- Infezioni
- Malattie virali
- Malattie dell'apparato digerente
- Malattie del fegato
- Epatite, virale, umana
- Malattie trasmissibili
- Infezioni da virus del DNA
- Infezioni da Hepadnaviridae
- Epatite cronica
- Epatite
- Condizioni patologiche, segni e sintomi
- Epatite B
- Epatite B, cronica
Altri numeri di identificazione dello studio
- AB-10-8016
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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