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Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV (ALLY 3)

29 september 2015 uppdaterad av: Bristol-Myers Squibb

A Phase 3 Evaluation of Daclatasvir and Sofosbuvir in Treatment Naive and Treatment Experienced Subjects With Genotype 3 Chronic Hepatitis C Infection

To study the combination of Daclatasvir and Sofosbuvir for the treatment of hepatitis C virus (HCV) Genotype 3 infection

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

173

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • California
      • La Jolla, California, Förenta staterna, 92037
        • Scripps Clinic
      • Los Angeles, California, Förenta staterna, 90057
        • National Research Institute
      • Los Angeles, California, Förenta staterna, 90036
        • Peter J Ruane Md Inc
      • Los Angeles, California, Förenta staterna, 90069
        • Anthony M. Mills Md Inc
      • Pasadena, California, Förenta staterna, 91105
        • Huntington Medical Research Institutes
      • San Diego, California, Förenta staterna, 92123
        • Medical Associates Research Group
      • San Diego, California, Förenta staterna, 92114
        • Precision Research Institute, LLC
      • San Francisco, California, Förenta staterna, 94115
        • Quest Clinical Research
    • Florida
      • Deland, Florida, Förenta staterna, 32720
        • Midland Florida Clinical Research Center, LLC
      • Gainesville, Florida, Förenta staterna, 32610
        • University of Florida Hepatology Research
    • Georgia
      • Atlanta, Georgia, Förenta staterna, 30308
        • Atlanta Gastroenterology Associates
      • Marietta, Georgia, Förenta staterna, 30060
        • Gastrointestinal Specialists of Georgia
    • Illinois
      • Downers Grove, Illinois, Förenta staterna, 60515
        • DuPage Medical Group
    • Maryland
      • Baltimore, Maryland, Förenta staterna, 21202
        • Mercy Medical Center, Inc.
      • Baltimore, Maryland, Förenta staterna, 21229
        • Digestive Disease Associates, P.A.
    • Missouri
      • Kansas City, Missouri, Förenta staterna, 64131
        • Kansas City Research Institute
    • New Mexico
      • Santa Fe, New Mexico, Förenta staterna, 87505
        • Southwest CARE Center
    • New York
      • Manhasset, New York, Förenta staterna, 11030
        • North Shore University Hospital
      • Poughkeepsie, New York, Förenta staterna, 12601
        • Premier Medical Group of the Hudson Valley, PC
    • North Carolina
      • Asheville, North Carolina, Förenta staterna, 28801
        • Asheville Gastroenterology Associates, PA
      • Winston-salem, North Carolina, Förenta staterna, 27103
        • Digestive Health Specialists, PA
    • Pennsylvania
      • Perkasie, Pennsylvania, Förenta staterna, 18944
        • Main Line Gastroenterology Associates Pc
      • Pittsburgh, Pennsylvania, Förenta staterna, 15213
        • Center For Liver Diseases
    • Tennessee
      • Germantown, Tennessee, Förenta staterna, 38138
        • Gastro One
    • Texas
      • Arlington, Texas, Förenta staterna, 76012
        • Texas Clinical Research Institute, LLC
      • San Antonio, Texas, Förenta staterna, 78215
        • American Research Corporation
    • Utah
      • Murray, Utah, Förenta staterna, 84123
        • Clinical Research Centers Of America
      • Salt Lake City, Utah, Förenta staterna, 84106
        • Lifetree Clinical Research
    • Virginia
      • Falls Church, Virginia, Förenta staterna, 22042
        • Inova Fairfax Hospital
    • Washington
      • Seattle, Washington, Förenta staterna, 98101
        • Virginia Mason Medical Center
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Fundacion De Investigacion de Diego

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Key Inclusion Criteria:

  • Subjects must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications
  • Subjects chronically infected with hepatitis C virus (HCV) genotype 3
  • Subjects who are HCV treatment-naive
  • Subjects who are HCV treatment-experienced (previous exposure to non-structural 5A inhibitors is prohibited)
  • HCV RNA ≥10,000 IU/mL at screening

Key Exclusion Criteria:

  • HCV Genotypes other than genotype-3 infection; mixed genotype infections are not permitted
  • Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair
  • 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 screening
  • Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed)
  • Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: A1:Daclatasvir + Sofosbuvir in treatment-naive subjects
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
Läkemedel: Sofosbuvir
Läkemedel: Daclatasvir
Andra namn:
  • BMS-790052
Experimentell: A2:Daclatasvir + Sofosbuvir in treatment-experienced subjects
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
Läkemedel: Sofosbuvir
Läkemedel: Daclatasvir
Andra namn:
  • BMS-790052

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)
Tidsram: Week 12 (Follow-up period)
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, TD or TND at follow-up Week 12. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.
Week 12 (Follow-up period)
Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)
Tidsram: Week 12 (Follow-up period)
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Week 12 (Follow-up period)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND)
Tidsram: Week 4
RVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 4. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Week 4
Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND)
Tidsram: Week 12
cEVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Week 12
Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND)
Tidsram: Up to the end of treatment (up to 24 weeks)
EOTR were defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at end of treatment. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Up to the end of treatment (up to 24 weeks)
Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND)
Tidsram: Week 1, 2, 6, 8 (treatment period)
Percentage of participants who achieved HCV RNA <LLOQ, TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Week 1, 2, 6, 8 (treatment period)
Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND)
Tidsram: Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period)
Percentage of participants who achieved HCV RNA <LLOQ,TD or TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period)
Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)
Tidsram: Baseline, Week 12 (Follow-up period)
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie. 25 IU/mL, target detected or target not detected at follow-up Week 12. Cirrhosis was considered a negative predictor of SVR in participants treated with an interferon formulation or ribavirin. Presence or absence of cirrhosis was determined at baseline and follow-up Week 12 in the participants to evaluate the post-treatment relapse.
Baseline, Week 12 (Follow-up period)
Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms (SNPs) Who Achieved Sustained Virologic Response After 12 Weeks of Follow-up (SVR12)
Tidsram: Week 12 (Follow-up period)
Participants categorized into 2 genotypes (CC and non-CC) based on SNPs in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus (HCV) RNA levels below lower limit of quantitation (LLOQ) below target detected or target not detected at follow-up Week 12 (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Week 12 (Follow-up period)
Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)
Tidsram: From Day 1 first dose to last dose plus 7 days
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.
From Day 1 first dose to last dose plus 7 days

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Bristol-Myers Squibb

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2014

Primärt slutförande (Faktisk)

1 september 2014

Avslutad studie (Faktisk)

1 december 2014

Studieregistreringsdatum

Först inskickad

9 januari 2014

Först inskickad som uppfyllde QC-kriterierna

9 januari 2014

Första postat (Uppskatta)

10 januari 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

1 oktober 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 september 2015

Senast verifierad

1 september 2015

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • AI444-218

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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