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Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care

23 settembre 2015 aggiornato da: Bristol-Myers Squibb

Parallel, Open-Label, Randomized Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of PSI-7977 in Combination With BMS-790052 With or Without Ribavirin in Treatment Naive Subjects Chronically Infected With Hepatitis C Virus Genotypes 1, 2, or 3

The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV RNA 12 weeks post treatment

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

350

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Porto Rico
      • San Juan, Porto Rico, 00927
        • Local Institution
  • Stati Uniti
    • California
      • Coronado, California, Stati Uniti, 92118
        • Southern California Liver Centers
      • San Diego, California, Stati Uniti, 92105
        • Research and Education, Inc.
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
        • University Of Colorado Denver & Hospital
    • Florida
      • Gainesville, Florida, Stati Uniti, 32610
        • University Of Florida Hepatology
      • Orlando, Florida, Stati Uniti, 32803
        • Orlando Immunology Center
      • South Miami, Florida, Stati Uniti, 33143
        • Miami Research Associates
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21202
        • Mercy Medical Center
      • Lutherville, Maryland, Stati Uniti, 21093
        • Johns Hopkins University
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48109
        • University of Michigan Health System
    • New York
      • Bronx, New York, Stati Uniti, 10468
        • Bronx Va Medical Center 3c Sub-J
      • New York, New York, Stati Uniti, 10021
        • Weill Cornell Medical College
    • Oklahoma
      • Tulsa, Oklahoma, Stati Uniti, 74104
        • Options Health Research, LLC
      • Tulsa, Oklahoma, Stati Uniti, 74135
        • Healthcare Research Consultants
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • University of Pennsylvania
    • Texas
      • San Antonio, Texas, Stati Uniti, 78215
        • Alamo Medical Research
    • Virginia
      • Annandale, Virginia, Stati Uniti, 22003
        • Metropolitan Research
    • Wisconsin
      • Madison, Wisconsin, Stati Uniti, 53715
        • Dean Clinic

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

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Men and women, ages 18 to 70 years.
  • Participants infected with hepatitis C virus (HCV) genotype 1, 2, or 3, with no previous exposure to an interferon formulation (ie, interferon-alpha, pegylated interferon-alpha) ribavirin, or other HCV-specific direct-acting antiviral (including daclatasvir and PSI-7977).
  • Patients should have chronic hepatitis C genotype 1a, 1b, 2, or 3 as documented by: positive test results for anti-HCV antibody; HCV RNA; or a HCV genotype at least 6 months prior to screening, and HCV RNA and anti-HCV antibody at the time of screening.

Exclusion Criteria:

  • Evidence of a medical condition associate with chronic liver disease other than HCV.
  • History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis.
  • History of hemophilia.
  • History of torsade de pointes.
  • Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment.
  • History of gastrointestinal disease or surgical procedure (except cholecystectomy).
  • History of clinically significant cardiac disease.
  • Blood transfusion within 4 weeks prior to study drug administration.
  • Poor venous access.
  • Any other medical, psychiatric, and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation in this study.

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: Treatment A: PSI-7977 + Daclatasvir
Genotype 1a or 1b
Droga: PSI-7977
Tablets, oral, 400 mg, once daily
Droga: Daclatasvir
Tablets, oral, 60 mg, once daily
Altri nomi:
  • BMS-790052
Sperimentale: Treatment B: PSI-7977 + Daclatasvir
Genotype 2 or 3
Droga: PSI-7977
Tablets, oral, 400 mg, once daily
Droga: Daclatasvir
Tablets, oral, 60 mg, once daily
Altri nomi:
  • BMS-790052
Sperimentale: Treatment C: PSI-7977 + Daclatasvir
Genotype 1a or 1b
Droga: PSI-7977
Tablets, oral, 400 mg, once daily
Droga: Daclatasvir
Tablets, oral, 60 mg, once daily
Altri nomi:
  • BMS-790052
Sperimentale: Treatment D: PSI-7977 + Daclatasvir
Genotype 2 or 3
Droga: PSI-7977
Tablets, oral, 400 mg, once daily
Droga: Daclatasvir
Tablets, oral, 60 mg, once daily
Altri nomi:
  • BMS-790052
Sperimentale: Treatment E: PSI-7977 + Daclatasvir + Ribavirin
Genotype 1a or 1b
Droga: PSI-7977
Tablets, oral, 400 mg, once daily
Droga: Daclatasvir
Tablets, oral, 60 mg, once daily
Altri nomi:
  • BMS-790052
Droga: Ribavirin
Tablets, oral, 200 mg
Altri nomi:
  • Copegus ®
Sperimentale: Treatment F: PSI-7977 + Daclatasvir+ Ribavirin
Genotype 2 or 3
Droga: PSI-7977
Tablets, oral, 400 mg, once daily
Droga: Daclatasvir
Tablets, oral, 60 mg, once daily
Altri nomi:
  • BMS-790052
Droga: Ribavirin
Tablets, oral, 200 mg
Altri nomi:
  • Copegus ®
Sperimentale: Treatment G: PSI-7977 + Daclatasvir

Hepatitis C virus genotype 1, treatment-naive patients

Genotype 1a or 1b
Droga: PSI-7977
Tablets, oral, 400 mg, once daily
Droga: Daclatasvir
Tablets, oral, 60 mg, once daily
Altri nomi:
  • BMS-790052
Sperimentale: Treatment H: PSI-7977 + BMS-790052 + Ribavirin

Hepatitis C virus genotype 1, treatment-naive patients

Genotype 1a or 1b
Droga: PSI-7977
Tablets, oral, 400 mg, once daily
Droga: Daclatasvir
Tablets, oral, 60 mg, once daily
Altri nomi:
  • BMS-790052
Droga: Ribavirin
Tablets, oral, 200 mg
Altri nomi:
  • Copegus ®
Sperimentale: Treatment I: PSI-7977 + Daclatasvir

Patients who experienced telaprevir/boceprevir treatment failure

Genotype 1a or 1b
Droga: PSI-7977
Tablets, oral, 400 mg, once daily
Droga: Daclatasvir
Tablets, oral, 60 mg, once daily
Altri nomi:
  • BMS-790052
Sperimentale: Treatment J: PSI-7977 + Daclatasvir + Ribavirin

Patients who experienced telaprevir/boceprevir treatment failure

Genotype 1a or 1b
Droga: PSI-7977
Tablets, oral, 400 mg, once daily
Droga: Daclatasvir
Tablets, oral, 60 mg, once daily
Altri nomi:
  • BMS-790052
Droga: Ribavirin
Tablets, oral, 200 mg
Altri nomi:
  • Copegus ®

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12)
Lasso di tempo: Follow-up Week 12
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected (ie, HCV RNA <25 IU/mL) at follow-up Week 12. DCV=daclatasvir, SOF=sofosbuvir.
Follow-up Week 12

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)
Lasso di tempo: Follow-up Week 24
SVR24 was defined as participant's hepatitis C virus RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 24. DCV=daclatasvir, SOF=sofosbuvir.
Follow-up Week 24
Percentage of Participants With Viral Breakthrough During the Treatment Period
Lasso di tempo: First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group)
Viral breakthrough is defined as any confirmed increase in viral load ≥1 log from nadir or any confirmed hepatitis C virus RNA levels ≥25 IU/mL on or after Week 8.
First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group)
Percentage of Participants Who Experienced Viral Relapse During Follow-up Period
Lasso di tempo: Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks)
Viral relapse during follow-up is defined as any confirmed quantifiable hepatitis C virus (HCV) RNA ≥25 IU/mL with HCV RNA levels less than the lower limit of quantitation, target detected or target not detected, ie, HCV RNA <25 IU/mL at the end of treatment.
Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks)
Change From Baseline in log10 Hepatitis C Virus (HCV) RNA at Follow-up Week 24
Lasso di tempo: Baseline, Follow-up week 24
Change from baseline in log10 HCV RNA at scheduled sampling time.
Baseline, Follow-up week 24
Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy
Lasso di tempo: First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group)
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe.
First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group)
Number of Participants Who Died and With Serious Adverse Events (SAEs), Grade 3-4 Adverse Events (AEs), and Grade 3-4 Abnormalities on Laboratory Test Results During Follow-up Period
Lasso di tempo: AEs: From Day 1 of follow-up period (Week 13 or 25) up to study discharge (up to 72 weeks). SAEs: From Day 1 of follow-up period (Week 13 or 25) up to 30 days after study discharge (up to 74 weeks)
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe
AEs: From Day 1 of follow-up period (Week 13 or 25) up to study discharge (up to 72 weeks). SAEs: From Day 1 of follow-up period (Week 13 or 25) up to 30 days after study discharge (up to 74 weeks)

Collaboratori e investigatori

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

Sponsor

Bristol-Myers Squibb

Collaboratori

Pharmasset

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

1 giugno 2011

Completamento primario (Effettivo)

1 gennaio 2013

Completamento dello studio (Effettivo)

1 ottobre 2013

Date di iscrizione allo studio

Primo inviato

23 maggio 2011

Primo inviato che soddisfa i criteri di controllo qualità

24 maggio 2011

Primo Inserito (Stima)

25 maggio 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

23 ottobre 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 settembre 2015

Ultimo verificato

1 settembre 2015

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • AI444-040

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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