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A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection (CERTAIN-1)

14 luglio 2021 aggiornato da: AbbVie

A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection (CERTAIN-1)

The purpose of this phase 3, multicenter study is to evaluate the efficacy and safety of ABT-493/ABT-530 in Japanese adults with chronic Hepatitis C Virus (HCV)-infected, HCV direct-acting antiviral agent (DAA) treatment-naïve, and DAA treatment-experienced Japanese adult subjects.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The study consisted of two sub-studies that enrolled in parallel. Substudy 1 was randomized, open-label, and active-controlled, wherein HCV treatment-naïve or interferon (IFN)-experienced (i.e., DAA treatment-naïve), genotype (GT)1-infected participants without cirrhosis were enrolled. Substudy 2 was non-randomized, open label, and enrolled special populations of HCV-infected participants [GT1- or GT2-infected subjects with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected subjects (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected subjects who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), HCV GT1- or GT2-infected subjects with severe renal impairment (with compensated cirrhosis or without cirrhosis)].

Tipo di studio

Interventistico

Iscrizione (Effettivo)

295

Fase

  • Fase 3

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Females were postmenopausal for at least 2 years; surgically sterile or had a vasectomized partner; or, if of childbearing potential and sexually active with a male partner, were currently using at least 1 effective method of birth control at the time of Screening and agreed to practice 1 effective method of birth control from Screening through 30 days after stopping study drug. Sexually active males were surgically sterile or, if sexually active with a female partner of childbearing potential, agreed to practice 1 effective form of birth control from Screening through 30 days after stopping study drug.
  • Screening central laboratory result indicated HCV single genotype infection for the appropriate treatment arm, without co-infection of any other genotype.

  • Chronic HCV infection is defined as one of the following:

    • Positive for anti-HCV antibody (Ab) and/or HCV RNA at least 6 months before Screening.
    • A liver biopsy consistent with chronic HCV infection.
  • Agreed to voluntarily sign and date an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) prior to the initiation of any screening or study specific procedures.
  • Participants who were able to understand and adhere to the study visit schedule and all other protocol requirements.
  • Absence of hepatocellular carcinoma (HCC) as indicated by an ultrasound, computed tomography (CT) scan or magnetic resonance imaging (MRI).

Exclusion Criteria:

  • Females who were pregnant or planned to become pregnant, or breastfeeding or males whose partner was pregnant or planning to become pregnant during the study.
  • Participants co-infected with hepatitis B virus or human immunodeficiency virus.
  • Use of contraindicated medications or supplements within 2 weeks or 10 half-lives (if known), whichever was longer, prior to the first dose of any study drug.
  • Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
  • Any cause of liver disease other than chronic HCV infection.
  • Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of decompensated liver disease.
  • Consideration by the investigator, for any reason, that the participant is an unsuitable candidate to receive ABT-493/ABT-530.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Arm A
ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) for 8 weeks in HCV genotype(GT)1 -infected, DAA treatment-naïve participants without cirrhosis.
Droga: ABT-493/ABT-530
Compressa co-formulata
Altri nomi:
  • Glecaprevir/Pibrentasvir
  • glecaprevir (ABT-493)
  • pibrentasvir (ABT-530)
Comparatore attivo: Arm B
Ombitasvir (25 mg)/paritaprevir (150 mg)/ritonavir (100mg) (OBV/PTV/r) QD for 12 weeks in HCV GT1 infected, DAA treatment-naïve participants without cirrhosis.
Droga: OBV/PTV/r
Co-formulated tablet
Altri nomi:
  • Ombitasvir/paritaprevir/ritonavir
  • ombitasvir (ABT-267)
  • paritaprevir (ABT-450)
  • norvir (ritonavir)
Sperimentale: Arm C
ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120mg) QD for 12 weeks in HCV GT1- or GT2-infected participants with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected participants (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected participants who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), and HCV GT1- or GT2-infected participants with severe renal impairment and compensated cirrhosis.
Droga: ABT-493/ABT-530
Compressa co-formulata
Altri nomi:
  • Glecaprevir/Pibrentasvir
  • glecaprevir (ABT-493)
  • pibrentasvir (ABT-530)
Sperimentale: Arm D
ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in GT1- or GT2-infected participants with severe renal impairment and without cirrhosis.
Droga: ABT-493/ABT-530
Compressa co-formulata
Altri nomi:
  • Glecaprevir/Pibrentasvir
  • glecaprevir (ABT-493)
  • pibrentasvir (ABT-530)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants in Arms A and B With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Lasso di tempo: 12 weeks after the last actual dose of study drug
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.
12 weeks after the last actual dose of study drug

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants in Arm A With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Lasso di tempo: 12 weeks after the last actual dose of study drug
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. 95% CI was calculated using the normal approximation to the binomial distribution.
12 weeks after the last actual dose of study drug
Percentage of Participants for Each Sub-Population in Arms C and D With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Lasso di tempo: 12 weeks after the last actual dose of study drug
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Subpopulations defined as Genotype 1 and 2 infected cirrhotic participants, prior direct acting antiviral agent (DAA) treatment experienced (T-exp) participants, Genotype 3, 4, 5 or 6-infected participants, and participants with severe renal impairment (RI). 95% CI was calculated using the Wilson score method.
12 weeks after the last actual dose of study drug
Percentage of Participants With On-treatment Virologic Failure
Lasso di tempo: Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment
On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. 95% CI was calculated using the Wilson score method.
Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment
Percentage of Participants With Post-Treatment Relapse
Lasso di tempo: From the end of treatment through 12 weeks after the last dose of study drug
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants with HCV RNA levels < LLOQ at the end of treatment, excluding participants who were been shown to be re-infected. The confidence interval was calculated using the Wilson score method.
From the end of treatment through 12 weeks after the last dose of study drug

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AbbVie

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

22 febbraio 2016

Completamento primario (Effettivo)

14 novembre 2016

Completamento dello studio (Effettivo)

9 febbraio 2017

Date di iscrizione allo studio

Primo inviato

9 marzo 2016

Primo inviato che soddisfa i criteri di controllo qualità

9 marzo 2016

Primo Inserito (Stima)

14 marzo 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 luglio 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 luglio 2021

Ultimo verificato

1 luglio 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • M15-594

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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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