- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02032901
Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV (ALLY 3)
29. september 2015 oppdatert 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
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
173
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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California
-
La Jolla, California, Forente stater, 92037
- Scripps Clinic
-
Los Angeles, California, Forente stater, 90057
- National Research Institute
-
Los Angeles, California, Forente stater, 90036
- Peter J Ruane Md Inc
-
Los Angeles, California, Forente stater, 90069
- Anthony M. Mills Md Inc
-
Pasadena, California, Forente stater, 91105
- Huntington Medical Research Institutes
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San Diego, California, Forente stater, 92123
- Medical Associates Research Group
-
San Diego, California, Forente stater, 92114
- Precision Research Institute, LLC
-
San Francisco, California, Forente stater, 94115
- Quest Clinical Research
-
-
Florida
-
Deland, Florida, Forente stater, 32720
- Midland Florida Clinical Research Center, LLC
-
Gainesville, Florida, Forente stater, 32610
- University of Florida Hepatology Research
-
-
Georgia
-
Atlanta, Georgia, Forente stater, 30308
- Atlanta Gastroenterology Associates
-
Marietta, Georgia, Forente stater, 30060
- Gastrointestinal Specialists of Georgia
-
-
Illinois
-
Downers Grove, Illinois, Forente stater, 60515
- Dupage Medical Group
-
-
Maryland
-
Baltimore, Maryland, Forente stater, 21202
- Mercy Medical Center, Inc.
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Baltimore, Maryland, Forente stater, 21229
- Digestive Disease Associates, P.A.
-
-
Missouri
-
Kansas City, Missouri, Forente stater, 64131
- Kansas City Research Institute
-
-
New Mexico
-
Santa Fe, New Mexico, Forente stater, 87505
- Southwest CARE Center
-
-
New York
-
Manhasset, New York, Forente stater, 11030
- North Shore University Hospital
-
Poughkeepsie, New York, Forente stater, 12601
- Premier Medical Group of the Hudson Valley, PC
-
-
North Carolina
-
Asheville, North Carolina, Forente stater, 28801
- Asheville Gastroenterology Associates, PA
-
Winston-salem, North Carolina, Forente stater, 27103
- Digestive Health Specialists, PA
-
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Pennsylvania
-
Perkasie, Pennsylvania, Forente stater, 18944
- Main Line Gastroenterology Associates Pc
-
Pittsburgh, Pennsylvania, Forente stater, 15213
- Center For Liver Diseases
-
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Tennessee
-
Germantown, Tennessee, Forente stater, 38138
- Gastro One
-
-
Texas
-
Arlington, Texas, Forente stater, 76012
- Texas Clinical Research Institute, LLC
-
San Antonio, Texas, Forente stater, 78215
- American Research Corporation
-
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Utah
-
Murray, Utah, Forente stater, 84123
- Clinical Research Centers Of America
-
Salt Lake City, Utah, Forente stater, 84106
- Lifetree Clinical Research
-
-
Virginia
-
Falls Church, Virginia, Forente stater, 22042
- Inova Fairfax Hospital
-
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Washington
-
Seattle, Washington, Forente stater, 98101
- Virginia Mason Medical Center
-
-
-
-
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San Juan, Puerto Rico, 00927
- Fundacion De Investigacion de Diego
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: A1:Daclatasvir + Sofosbuvir in treatment-naive subjects
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
|
Andre navn:
|
Eksperimentell: A2:Daclatasvir + Sofosbuvir in treatment-experienced subjects
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
|
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)
Tidsramme: 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)
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Kowdley KV, Nelson DR, Lalezari JP, Box T, Gitlin N, Poleynard G, Rabinovitz M, Ravendhran N, Sheikh AM, Siddique A, Bhore R, Noviello S, Rana K. On-treatment HCV RNA as a predictor of sustained virological response in HCV genotype 3-infected patients treated with daclatasvir and sofosbuvir. Liver Int. 2016 Nov;36(11):1611-1618. doi: 10.1111/liv.13165. Epub 2016 Jun 16.
- Nelson DR, Cooper JN, Lalezari JP, Lawitz E, Pockros PJ, Gitlin N, Freilich BF, Younes ZH, Harlan W, Ghalib R, Oguchi G, Thuluvath PJ, Ortiz-Lasanta G, Rabinovitz M, Bernstein D, Bennett M, Hawkins T, Ravendhran N, Sheikh AM, Varunok P, Kowdley KV, Hennicken D, McPhee F, Rana K, Hughes EA; ALLY-3 Study Team. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology. 2015 Apr;61(4):1127-35. doi: 10.1002/hep.27726. Epub 2015 Mar 10.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2014
Primær fullføring (Faktiske)
1. september 2014
Studiet fullført (Faktiske)
1. desember 2014
Datoer for studieregistrering
Først innsendt
9. januar 2014
Først innsendt som oppfylte QC-kriteriene
9. januar 2014
Først lagt ut (Anslag)
10. januar 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
1. oktober 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. september 2015
Sist bekreftet
1. september 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AI444-218
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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