- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00812331
A Study to Assess the Anti-viral Activity, Safety, Tolerability and Pharmacokinetics of TMC435350 in Participants Infected With Hepatitis C-Virus (HCV)
1. juli 2014 oppdatert av: Tibotec Pharmaceuticals, Ireland
An Open-label Trial in Genotype 2, 3, 4, 5 and 6 Hepatitis C-infected Subjects to Evaluate the Antiviral Activity, Safety, Tolerability and Pharmacokinetics of TMC435350 Following 7 Days Once Daily Dosing as Monotherapy.
The purpose of this study is to assess anti-viral activity (inhibition of viral growth) of TMC435350 in genotype 2,3,4,5 and 6 hepatitis C virus infected participants who have never received treatment for their hepatitis C infection.
Studieoversikt
Detaljert beskrivelse
This is an open-label (all people know the identity of the intervention) study to assess the antiviral activity, safety, tolerability and pharmacokinetics (explores what the body does to the medication) of TMC435350 hereafter referred to as TMC435.
Approximately 40 participants will be divided in 5 groups as per the genotype (8 participants each group).
The study will include a screening phase (up to 6 weeks), treatment phase (7 days) and a follow-up phase (30-35 days after the last dose of study medication).
Safety evaluations will include assessment of adverse events, clinical laboratory tests and cardiovascular safety.
Studietype
Intervensjonell
Registrering (Faktiske)
37
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
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 til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Participants with documented chronic genotype 2, 3, 4, 5 or 6 hepatitis C virus (HCV) infection
- Participants who have never received treatment for their HCV infection
- Participants with either no cirrhosis or up to Child Pugh A liver disease
- Participants with plasma HCV genotype level of more than or equal to 100, 000 IU/mL at screening
Exclusion Criteria:
- Evidence of Child Pugh B or C liver disease at screening, decompensated liver disease defined as prior or current history of ascities, hepatic encephalopathy, esophageal or gastric varices
- Participants with diagnosed or suspected hepatocellular carcinoma
- Participants coinfected with human immunodeficiency virus type 1 or 2, or hepatitis A or B virus infection or active tuberculosis at screening
- Participants with any active clinically significant disease, or medical history or physical examination or electrocardiogram findings during screening
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: Genotype 2
Participants with chronic genotype 2 hepatitis C virus (HCV) infection
|
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
|
Eksperimentell: Genotype 3
Participants with chronic genotype 3 HCV infection
|
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
|
Eksperimentell: Genotype 4
Participants with chronic genotype 4 HCV infection
|
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
|
Eksperimentell: Genotype 5
Participants with chronic genotype 5 HCV infection
|
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
|
Eksperimentell: Genotype 6
Participants with chronic genotype 6 HCV infection
|
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change From Baseline in log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels
Tidsramme: Baseline, Day 3, and Day 7
|
The table below shows the mean changes from baseline in HCV RNA values (log10 IU/mL) per genotype on Day 3 and Day 7 during the TMC435 treatment period.
|
Baseline, Day 3, and Day 7
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With a Decrease From Baseline of Greater Than or Equal to 2 log10 IU/mL in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During the TMC435 Treatment Period
Tidsramme: Baseline, Day 3, Day 5 and Day 7
|
The table below shows the number of participants with a decrease from baseline of greater than or equal to 2 log10 IU/mL in HCV RNA during the 7-day TMC435 treatment period.
|
Baseline, Day 3, Day 5 and Day 7
|
Number of Participants With Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Below the Limit of Quantification (Less Than 25 IU/mL) and Limit of Detection (Less Than 25 IU/mL Undetectable) During the TMC435 Treatment Period
Tidsramme: Baseline, Day 3, Day 5 and Day 7
|
The table below shows the number of participants with plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels below limit of quantification (less than 25 IU/mL) and limit of detection (less than 25 IU/mL undetectable), respectively, during the 7-day TMC435 treatment period.
|
Baseline, Day 3, Day 5 and Day 7
|
Number of Participants Who Experienced Viral Breakthrough During TMC435 Treatment Period
Tidsramme: During the 7-day of TMC435 treatment period
|
The table below shows the number of participants who experienced viral breakthrough (defined as an increase greater than 1 log10 IU/mL in plasma level of hepatitis C virus [HCV] ribonucleic acid [RNA] from the lowest level reached, or a HCV RNA level greater than 100 IU/mL in participants who previously had HCV RNA levels undetectable [less than 25 IU/mL undetectable] or not quantifiable [less than 25 IU/mL detectable]) during the 7-day TMC435 treatment period.
|
During the 7-day of TMC435 treatment period
|
Predose Plasma Concentration (C0h) of TMC435
Tidsramme: Predose on Day 7
|
The table below shows the median predose plasma concentration (C0h) for all participants on Day 7 of the TMC435 treatment period.
|
Predose on Day 7
|
Minimum Plasma Concentration (Cmin) of TMC435
Tidsramme: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
The table below shows the median minimum plasma concentration (Cmin) for all participants on Day 7 of the TMC435 treatment period.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
Maximum Plasma Concentration (Cmax) of TMC435
Tidsramme: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
The table below shows the median maximum plasma concentration (Cmax) for all participants by genotype of hepatitis C virus infection on Day 7 of the TMC435 treatment period.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
Time to Reach the Maximum Plasma Concentration (Tmax) of TMC435
Tidsramme: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
The table below shows the median time in hours for all participants (by genotype of hepatitis C virus infection) to reach the maximum plasma concentration (tmax) of TMC435 following treatment.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
Average Steady-State Plasma Concentration (Css,av) of TMC435
Tidsramme: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
The table below shows the average steady-state TMC435 plasma concentration (Css,av) for all participants by genotype of hepatitis C virus infection on Day 7 during the TMC435 treatment period.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
Fluctuation Index (FI) of TMC435
Tidsramme: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
The table below shows the percentage of fluctuation (FI) (defined as the variation between maximum and minimum TMC435 plasma concentrations at steady-state) of TMC435 on Day 7 for participants by genotype of hepatitis C virus infection.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
Area Under the Plasma Concentration-time Curve From the Time of Administration up to 24 Hours After Dosing (AUC24h) of TMC435
Tidsramme: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
The table below shows the area under the plasma concentration-time curve from the time of administration up to 24 hours after dosing (AUC24h) of TMC435 on Day 7 for all participants by genotype of hepatitis C virus infection.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
Area Under the Plasma Concentration-time Curve From Time of Administration up to the Last Time Point With a Measurable Concentration After Dosing (AUClast) of TMC435
Tidsramme: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
The table below shows the area under the plasma concentration-time curve from time of administration up to the last time point with a measurable concentration after dosing (AUClast) on Day 7 for TMC435 by genotype of hepatitis C virus infection.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
Elimination Rate Constant of TMC435
Tidsramme: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
In the table below, median values for the elimination rate constant (the rate at which a drug is removed from the body expressed per unit of time, e.g., fraction/hour) for TMC435 are shown for participants by genotype of hepatitis C virus infection.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
Terminal Elimination Half-life (t1/2,Term) of TMC435
Tidsramme: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
The table below shows the terminal plasma half-life for TMC435 in participants analyzed by genotype of hepatitis C virus infection.
The terminal plasma half-life of a drug is the time in hours required for the concentration of a drug in the body to fall to 50% after having reached a state of equilibrium following administration.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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. mars 2009
Primær fullføring (Faktiske)
1. november 2009
Studiet fullført (Faktiske)
1. november 2009
Datoer for studieregistrering
Først innsendt
18. desember 2008
Først innsendt som oppfylte QC-kriteriene
18. desember 2008
Først lagt ut (Anslag)
22. desember 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
28. juli 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. juli 2014
Sist bekreftet
1. juli 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Leversykdommer
- Flaviviridae-infeksjoner
- Hepatitt, viral, menneskelig
- Enterovirusinfeksjoner
- Picornaviridae-infeksjoner
- Hepatitt
- Hepatitt A-virus
- Hepatitt C
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Enzymhemmere
- Proteasehemmere
- Simeprevir
Andre studie-ID-numre
- CR012604
- TMC435350-TiDP16-C202 (Annen identifikator: Tibotec Pharmaceuticals, Ireland)
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. .
Kliniske studier på Hepatitt C
-
Dokuz Eylul UniversityEge UniversityFullførtMMP9 | TIMP1 | MMP9 -1562 C/T | TIMP1 372 T/CTyrkia
-
Tripep ABInovio PharmaceuticalsUkjentKronisk hepatitt C virusinfeksjonSverige
-
Hadassah Medical OrganizationXTL BiopharmaceuticalsTilbaketrukketKronisk hepatitt C virusinfeksjonIsrael
-
Hadassah Medical OrganizationUkjentKronisk hepatitt C virusinfeksjonIsrael
-
Johann Wolfgang Goethe University HospitalFullført
-
Beni-Suef UniversityFullførtٍٍSofosbuvir/Simeprevir/Daclatasvir/Ribavirin og HCV genotype 4-infiserte egyptisk erfarne deltakereKronisk hepatitt C virusinfeksjonEgypt
-
University College CorkDupont Applied BiosciencesRekruttering
-
Trek Therapeutics, PBCFullførtKronisk hepatitt C | Hepatitt C genotype 1 | Hepatitt C (HCV) | Hepatitt C viral infeksjonForente stater, New Zealand
-
Trek Therapeutics, PBCFullførtKronisk hepatitt C | Hepatitt C (HCV) | Hepatitt C genotype 4 | Hepatitt C viral infeksjonForente stater
-
Meir Medical CenterFullførtUtvikle ny teknikk for å måle C/D-forhold fra digitale stereooptiske plater | Intraobserver reproduserbarhet av C/D-målinger | Interobservatørvariabilitet av C/D-målinger
Kliniske studier på TMC435
-
Tibotec Pharmaceuticals, IrelandFullført
-
Tibotec Pharmaceuticals, IrelandFullført
-
Janssen Research & Development, LLCFullført
-
Janssen R&D IrelandFullført
-
Tibotec Pharmaceuticals, IrelandFullført
-
Janssen R&D IrelandFullførtHepatitt CForente stater, Australia, Frankrike, Ukraina, Storbritannia, Belgia, Tyskland, Spania, Israel, Portugal, Bulgaria, Nederland, Canada, New Zealand, Den russiske føderasjonen, Argentina, Brasil, Puerto Rico, Østerrike, Polen, Romania, Mexi...
-
Tibotec Pharmaceuticals, IrelandFullført
-
Tibotec Pharmaceuticals, IrelandFullført
-
Tibotec Pharmaceuticals, IrelandFullførtHepatitt C-virusTsjekkisk Republikk
-
Janssen R&D IrelandFullførtHepatitt CForente stater, Australia, Frankrike, Polen, Storbritannia, Tyskland, Spania, Belgia, Israel, Portugal, Bulgaria, Romania, Danmark, Hellas, Sverige, Canada, Tsjekkisk Republikk, Argentina, Brasil, Østerrike, Ungarn, Sveits, Puerto Rico, Norg...