A Study of Peginterferon Alfa-2a Plus Ribavirin in Early Non-Responder Participants With Chronic Hepatitis C (CHC) Genotype 1, 4, 5, and 6
6. juni 2016 opdateret af: Hoffmann-La Roche
An Open-label Pilot Study of Dose Escalation of PEGASYS on Virological Response in Patients With Chronic Hepatitis C Viral Infection Showing an Early Non-response to a Standard Course of PEGASYS Plus Ribavirin
This multicenter, open-label, uncontrolled study will evaluate the efficacy and safety of increasing the dose of peginterferon alfa-2a (Pegasys) in participants with Genotype 1/4/5/6 CHC and an early non-response to a standard course of peginterferon alfa-2a plus ribavirin.
The study will consist of screening (4 weeks), treatment (32 weeks), and follow-up (24 weeks).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
23
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Antwerpen, Belgien, 2060
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Antwerpen, Belgien, 2018
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Brugge, Belgien, 8000
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Bruxelles, Belgien, 1020
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Bruxelles, Belgien, 1070
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Bruxelles, Belgien, 1200
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Bruxelles, Belgien, 1180
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Bruxelles, Belgien, 1000
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Bruxelles, Belgien, 1090
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Bruxelles, Belgien, 1190
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Charleroi, Belgien, 6000
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Edegem, Belgien, 2650
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Gent, Belgien, 9000
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Gilly, Belgien, 6060
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Haine-saint-paul, Belgien, 7100
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Kortrijk, Belgien, 8500
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Leuven, Belgien, 3000
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Liege, Belgien, 4000
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Namur, Belgien, 5000
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Roeselare, Belgien, 8800
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Yvoir, Belgien, 5530
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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:
- Participants with serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
- Participants had to have been receiving their first treatment for chronic hepatitis C (i.e. previously naive to any therapy) consisting of peginterferon alfa-2a plus ribavirin for 16 weeks (+/- 10 days), without reaching a negative or 2-log drop of Serum Hepatitis C Virus Ribonucleic Acid (HCV-RNA) at Week 12 of therapy as compared to pretreatment value, and must still be on therapy (no wash out)
- HCV-RNA quantifiable by a test reporting in international units
- Compensated liver disease (Child-Pugh Grade A clinical classification)
- Participants with cirrhosis or transition to cirrhosis had to have an abdominal ultrasound, computerized tomography (CT) scan, or magnetic resonance imaging (MRI) scan without evidence of hepatocellular carcinoma and a serum alpha fetoprotein (AFP) less than (<)100 nanogram pe milliliter (ng/mL) within 6 months of study entry
- Negative urine or blood pregnancy test
- Participants had to be using two forms of effective contraception during treatment and during the 6 months after treatment end
- Able to participate and to comply with the study restrictions
Exclusion Criteria:
- Women with ongoing pregnancy or who are breast feeding and male partners of women who were pregnant
- Neutrophil count <1,500 cells/cubic millimeter (mm^3) or platelet count <90,000 cells/mm^3 before initiation of the ongoing treatment regimen; or neutrophil count <750 cells/mm^3 or platelet count <50,000 cells/mm^3 at screening while still on therapy with peginterferon alfa-2a plus ribavirin
- Hemoglobin (Hgb) <12 gram per deciliter (g/dL) before initiation of the ongoing treatment regimen; or Hgb <10 g/dL at screening while still on therapy with peginterferon alfa-2a plus ribavirin for at least 12 weeks
- Serum creatinine level greater than (>)1.5 times the upper limit of normal at screening
- Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) other than the currently failing Pegasys plus ribavirin combination therapy less than or equal to (<=) 6 months prior to the first dose of study drug
- Positive test for hepatitis A immunoglobulin M (IgM) antibody (anti-HAV IgM Ab), hepatitis B surface antigen (HBsAg), anti-hepatitis B core IgM antibody (anti-HBc IgM Ab), anti-Human Immunodeficiency Virus antibody (anti-HIV Ab)
- History or other evidence of a medical condition associated with chronic liver disease other than HCV
- History of bleeding from esophageal varices or other conditions consistent with decompensated liver disease, severe psychiatric disease (especially depression), severe seizure disorder, thyroid disease, immunologically mediated disease, chronic pulmonary disease, cardiac disease, major organ transplantation or other evidence of severe illness, malignancy
- Evidence of drug abuse including excessive alcohol consumption
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Peginterferon Alfa-2a + Ribavirin
Participants will receive 360 microgram (mcg) of Peginterferon Alfa-2a subcutaneous (SC) once a week plus ribavirin (1000 - 1200 milligram per day [mg/day] orally as a split dose in the morning and the evening based on the participant's body weight) for 32 weeks.
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Andre navne:
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Percentage of Participants Achieving Virologic Response, as measured by ultrasensitive Roche HCV TaqMan Test
Tidsramme: Week 12
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Week 12
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Percentage of Participants Achieving Sustained Virologic Response (SVR), as measured by ultrasensitive Roche HCV TaqMan Test
Tidsramme: Week 56
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Week 56
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Percentage of Participants Achieving End-of-treatment Response, as measured by ultrasensitive Roche HCV TaqMan Test
Tidsramme: Week 32
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Week 32
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Mean Log Change From Baseline to Week 2, 4, 8, 12, 32, and 56 in Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Viral Load
Tidsramme: Baseline, Week 2, 4, 8, 12, 32, 56
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Baseline, Week 2, 4, 8, 12, 32, 56
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Number of Participants With Adverse Events and Serious Adverse
Tidsramme: Baseline up to Week 56
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Baseline up to Week 56
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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 2005
Primær færdiggørelse (Faktiske)
1. juni 2008
Studieafslutning (Faktiske)
1. juni 2008
Datoer for studieregistrering
Først indsendt
31. maj 2016
Først indsendt, der opfyldte QC-kriterier
1. juni 2016
Først opslået (Skøn)
6. juni 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. juni 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. juni 2016
Sidst verificeret
1. juni 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
- Antimetabolitter
- Ribavirin
- Peginterferon alfa-2a
Andre undersøgelses-id-numre
- ML18232
- 2005-000198-22 (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 .