ANNAPURNA: A Study of The Combination of RO5466731, RO5190591, Ritonavir and Copegus (Ribavirin) With or Without RO5024048 in Patients With Chronic Hepatitis C Who Are Either Treatment-Naïve or Have Previously Experienced a Null Response to Interferon-Based Treatment
1. november 2016 opdateret af: Hoffmann-La Roche
Randomized, Open-Label, Multicenter Study of Safety, Efficacy, and Tolerability of the Combination of RO5466731, RO5190591, Ritonavir, and Copegus With or Without RO5024048 in HCV Genotype 1 Infected Patients Who Are Either Treatment Naïve or Null Responders to Previous Interferon-Based Treatment
This randomized, open-label, multicenter study will evaluate the safety , efficacy and tolerability of the combination treatment RO5466731, RO5190591, ritonavir and Copegus (ribavirin) with or without RO5024048 in patients with chronic hepatitis C genotype 1.
In Part 1, treatment-naïve patients will be randomized to receive treatment with RO5466731, RO5190591 plus ritonavir, and Copegus, with or without RO5024048.
In Part 2, further treatment-naïve patients will receive a successful regimen from Part 1, or a reduced intensity regimen, and patients who have previously experienced null response to interferon-based treatment will be added to the study.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
110
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New South Wales
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Kingswood, New South Wales, Australien
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Sydney, New South Wales, Australien, 2050
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Westmead, New South Wales, Australien, 2145
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Queensland
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Herston, Queensland, Australien, 4029
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Victoria
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Parkville, Victoria, Australien, 3052
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California
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LaJolla, California, Forenede Stater, 92037
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Colorado
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Englewood, Colorado, Forenede Stater, 80113
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Florida
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South Miami, Florida, Forenede Stater, 33143
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Georgia
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Marietta, Georgia, Forenede Stater, 30060
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96813
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Illinois
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Chicago, Illinois, Forenede Stater, 60637
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
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Michigan
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Detroit, Michigan, Forenede Stater, 48202
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Missouri
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Saint Louise, Missouri, Forenede Stater, 63104
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28801
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Texas
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Dallas, Texas, Forenede Stater, 75246
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Houston, Texas, Forenede Stater, 77030
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San Antonio, Texas, Forenede Stater, 78215
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San Antonio, Texas, Forenede Stater, 78234
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Washington
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Vancouver, Washington, Forenede Stater, 98664
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Dunedin, New Zealand, 9016
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Grafton, New Zealand, 1010
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Hamilton, New Zealand
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Bialystok, Polen, 15-540
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Chorzow, Polen, 41-500
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Lodz, Polen, 91-357
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Myslowice, Polen, 41-400
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Berlin, Tyskland, 13353
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Frankfurt Am Main, Tyskland, 60590
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Hamburg, Tyskland, 20099
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Hannover, Tyskland, 30625
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Chronic hepatitis C genotype 1 of >/= 6 months duration at screening
- Part 1 and Part 2: Naïve to treatment with interferon (pegylated or non-pegylated). Patients who have participated in studies investigating a direct-acting antiviral agent with or without interferon are excluded
- Part 2: Treatment experienced patients having a previous null response to treatment with interferon containing regimen
- Liver biopsy or non-invasive (e.g. Fibroscan) evaluation in the past 24 calendar months showing absence of cirrhosis or incomplete/transition to cirrhosis
- Body mass index (BMI) 18 to 35 kg/m2 inclusive and body weight >/= 45 kg
Exclusion Criteria:
- Pregnant or lactating women or males with female partners who are pregnant or lactating
- Decompensated liver disease or impaired liver function (as defined by protocol)
- Cirrhosis or incomplete/transition to cirrhosis
- Non- hepatitis C chronic liver disease
- Positive for hepatitis B or HIV infection
- History of pre-existing renal disease
- History of severe cardiac disease
- History of neoplastic disease within the last 5 years, except for localized or in situ carcinoma of the skin
- History of drug abuse within the last year; history of cannabinoid use is not excluded
- Evidence of alcohol abuse within 1 year of screening and consumption of more than 2 units of alcohol per day
- Medical condition that requires use of systemic corticosteroids
- Received warfarin or other anticoagulants during the 21 days immediately prior to screening or is expected to require warfarin or other anticoagulants during the study
- Anticipated use or need for significant medical treatment during the study or use of concomitant medications or nutrients that are excluded by protocol (e.g. drugs that are contraindicated with ritonavir, hormonal methods of contraception)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: A: GT1a 3DAA
including RO5466731, RO5190591, ritonavir, ribavirin [Copegus] and RO5024048
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Eksperimentel: B: GT1a 3DAA
including RO5466731, RO5190591, ritonavir, ribavirin [Copegus] and RO5024048
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Eksperimentel: C: GT1a 2DAA
including RO5466731, RO5190591, ritonavir and ribavirin [Copegus]
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Eksperimentel: D: GT1b 3DAA
including RO5466731, RO5190591, ritonavir, ribavirin [Copegus] and RO5024048
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Eksperimentel: E: GT1b 2DAA
including RO54664731, RO5190591, ritonavir and ribavirin [Copegus]
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Eksperimentel: Part II
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Sustained virological response (defined as undetectable serum HCV RNA) 12 weeks after end of treatment
Tidsramme: approximately 20 months
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approximately 20 months
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Safety: Incidence of adverse events
Tidsramme: approximately 20 months
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approximately 20 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Antiviral activity: Change in serum HCV RNA levels
Tidsramme: from baseline to 24 weeks after end of treatment
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from baseline to 24 weeks after end of treatment
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Pharmacokinetics in coadministration: Area under the concentration-time curve (AUC)
Tidsramme: Pre-dose Weeks 1, 2, 3, 4, 6, 10, and 12 and up to 12 hours post-dose Weeks 1, and 4 or 3 and 6
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Pre-dose Weeks 1, 2, 3, 4, 6, 10, and 12 and up to 12 hours post-dose Weeks 1, and 4 or 3 and 6
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HCV drug resistance
Tidsramme: approximately 20 months
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approximately 20 months
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Quality of life: Short-Form 36v2/Brief Fatigue Inventory questionnaires
Tidsramme: approximately 20 months
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approximately 20 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2012
Primær færdiggørelse (Faktiske)
1. november 2013
Studieafslutning (Faktiske)
1. november 2013
Datoer for studieregistrering
Først indsendt
22. juni 2012
Først indsendt, der opfyldte QC-kriterier
22. juni 2012
Først opslået (Skøn)
26. juni 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
2. november 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. november 2016
Sidst verificeret
1. november 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- Blodbårne infektioner
- Overførbare sygdomme
- Leversygdomme
- Flaviviridae infektioner
- Hepatitis, viral, menneskelig
- Enterovirus infektioner
- Picornaviridae infektioner
- Hepatitis, kronisk
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C, kronisk
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Enzymhæmmere
- Anti-HIV-midler
- Anti-retrovirale midler
- Antimetabolitter
- Proteasehæmmere
- Cytokrom P-450 CYP3A-hæmmere
- Cytokrom P-450 enzymhæmmere
- HIV-proteasehæmmere
- Virale proteasehæmmere
- Ribavirin
- Ritonavir
Andre undersøgelses-id-numre
- NP28266
- 2012-000638-21 (EudraCT nummer)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .