- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00704184
Safety and Efficacy of Vaniprevir (MK7009) Administered With Pegylated-Interferon and Ribavirin (MK-7009-007)
10. september 2018 opdateret af: Merck Sharp & Dohme LLC
A Phase II, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Treatment-Naive Patients With Chronic Hepatitis C Infection
A study to evaluate how effective different levels of Vaniprevir (MK-7009), when administered with Pegylated-Interferon (Peg-IFN) and Ribavirin, are at achieving rapid viral response (RVR) i.e., undetectable hepatitis C virus [HCV] viral ribonucleic acid [RNA] at Week 4 in participants with chronic HCV infection.
The primary hypothesis was that the proportion of participants in one or more of the Vaniprevir treatment groups achieving RVR would be greater than the proportion of placebo participants achieving RVR when Vaniprevir and placebo were co-administered with Peg-IFN/Ribavirin.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
95
Fase
- Fase 2
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 til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patient has chronic Genotype 1 Hepatitis C infection
Exclusion Criteria:
- Subject has been previously treated for HCV
- Has Human Immunodeficiency Virus (HIV)
- Has Hepatitis B
- Has a history of clinically significant medical condition that may interfere with the study (e.g., stroke or chronic seizures or major neurological disorder) or is contraindicated for treatment with peg-IFN and Ribavirin
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: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Placebo komparator: Placebo + Peg-IFN/Ribavirin
Participants took double-blind Placebo + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
|
Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks
Ribavirin 200 mg tablet b.i.d.
(dose based on body weight); duration of treatment: 48 weeks
|
Eksperimentel: Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 300 mg twice daily (b.i.d.) + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
|
Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks
Ribavirin 200 mg tablet b.i.d.
(dose based on body weight); duration of treatment: 48 weeks
Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days
Andre navne:
|
Eksperimentel: Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg b.i.d.
+ Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
|
Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks
Ribavirin 200 mg tablet b.i.d.
(dose based on body weight); duration of treatment: 48 weeks
Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days
Andre navne:
|
Eksperimentel: Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg q.d.
+ Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
|
Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks
Ribavirin 200 mg tablet b.i.d.
(dose based on body weight); duration of treatment: 48 weeks
Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days
Andre navne:
|
Eksperimentel: Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 800 mg q.d.
+ Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
|
Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks
Ribavirin 200 mg tablet b.i.d.
(dose based on body weight); duration of treatment: 48 weeks
Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days
Andre navne:
Matching placebo to vaniprevir; duration of treatment: 28 days
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Participants Achieving RVR
Tidsramme: Week 4
|
Rapid Viral Response (RVR) was declared if Hepatitis C Virus (HCV) ribonucleic acid (RNA) was undetectable at Week 4.
|
Week 4
|
Number of Participants Experiencing an Adverse Event (AE)
Tidsramme: Up to Day 42
|
The number of participants experiencing AEs in each treatment group was monitored during the Vaniprevir/Placebo treatment (Day 1 to Day 28) and safety follow-up (Day 29 to Day 42) periods.
|
Up to Day 42
|
Number of Participants Discontinuing From Study Therapy Due to AEs
Tidsramme: Day 1 to Day 28
|
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study therapy, whether or not considered related to the use of the product.
|
Day 1 to Day 28
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With ≥2-log10 Decrease in HCV RNA
Tidsramme: Baseline and Week 4
|
The number of participants with at least a 2-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.
|
Baseline and Week 4
|
Number of Participants With ≥3-log10 Decrease in HCV RNA
Tidsramme: Baseline and Week 4
|
The number of participants with at least a 3-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.
|
Baseline and Week 4
|
Mean Log Change From Baseline in HCV RNA
Tidsramme: Baseline and Week 4
|
The mean changes from baseline in log10 HCV RNA in each vaniprevir group was compared against control treatment at Week 4.
|
Baseline and Week 4
|
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.
Generelle publikationer
- Manns MP, Gane E, Rodriguez-Torres M, Stoehr A, Yeh CT, Marcellin P, Wiedmann RT, Hwang PM, Caro L, Barnard RJ, Lee AW; MK-7009 Protocol 007 Study Group. Vaniprevir with pegylated interferon alpha-2a and ribavirin in treatment-naive patients with chronic hepatitis C: a randomized phase II study. Hepatology. 2012 Sep;56(3):884-93. doi: 10.1002/hep.25743. Epub 2012 Jul 17.
- Lawitz E, Sulkowski M, Jacobson I, Kraft WK, Maliakkal B, Al-Ibrahim M, Gordon SC, Kwo P, Rockstroh JK, Panorchan P, Miller M, Caro L, Barnard R, Hwang PM, Gress J, Quirk E, Mobashery N. Characterization of vaniprevir, a hepatitis C virus NS3/4A protease inhibitor, in patients with HCV genotype 1 infection: safety, antiviral activity, resistance, and pharmacokinetics. Antiviral Res. 2013 Sep;99(3):214-20. doi: 10.1016/j.antiviral.2013.05.015. Epub 2013 Jun 7.
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 (Faktiske)
25. juli 2008
Primær færdiggørelse (Faktiske)
12. december 2008
Studieafslutning (Faktiske)
14. april 2010
Datoer for studieregistrering
Først indsendt
23. juni 2008
Først indsendt, der opfyldte QC-kriterier
23. juni 2008
Først opslået (Skøn)
24. juni 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. oktober 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. september 2018
Sidst verificeret
1. september 2018
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
- Hepatitis
- Hepatitis C
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Antimetabolitter
- Antineoplastiske midler
- Interferoner
- Ribavirin
Andre undersøgelses-id-numre
- 7009-007
- MK7009-007
- 2007_658
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Studiedata/dokumenter
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 .
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