- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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 aktualisiert von: 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.
Studienübersicht
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
37
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Brugge, Belgien
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Brussels, Belgien
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Bruxelles, Belgien
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Gent, Belgien
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Leuven, Belgien
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Berlin, Deutschland
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Frankfurt N/A, Deutschland
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Freiburg, Deutschland
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Hannover, Deutschland
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Bangkok, Thailand
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Chiang Mai, Thailand
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Genotype 2
Participants with chronic genotype 2 hepatitis C virus (HCV) infection
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From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
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Experimental: Genotype 3
Participants with chronic genotype 3 HCV infection
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From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
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Experimental: Genotype 4
Participants with chronic genotype 4 HCV infection
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From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
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Experimental: Genotype 5
Participants with chronic genotype 5 HCV infection
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From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
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Experimental: Genotype 6
Participants with chronic genotype 6 HCV infection
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From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Change From Baseline in log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels
Zeitfenster: Baseline, Day 3, and Day 7
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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.
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Baseline, Day 3, and Day 7
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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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
Zeitfenster: Baseline, Day 3, Day 5 and Day 7
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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.
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Baseline, Day 3, Day 5 and Day 7
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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
Zeitfenster: Baseline, Day 3, Day 5 and Day 7
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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.
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Baseline, Day 3, Day 5 and Day 7
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Number of Participants Who Experienced Viral Breakthrough During TMC435 Treatment Period
Zeitfenster: During the 7-day of TMC435 treatment period
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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.
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During the 7-day of TMC435 treatment period
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Predose Plasma Concentration (C0h) of TMC435
Zeitfenster: Predose on Day 7
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The table below shows the median predose plasma concentration (C0h) for all participants on Day 7 of the TMC435 treatment period.
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Predose on Day 7
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Minimum Plasma Concentration (Cmin) of TMC435
Zeitfenster: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
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The table below shows the median minimum plasma concentration (Cmin) for all participants on Day 7 of the TMC435 treatment period.
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Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
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Maximum Plasma Concentration (Cmax) of TMC435
Zeitfenster: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
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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.
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Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
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Time to Reach the Maximum Plasma Concentration (Tmax) of TMC435
Zeitfenster: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
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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.
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Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
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Average Steady-State Plasma Concentration (Css,av) of TMC435
Zeitfenster: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
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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.
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Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
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Fluctuation Index (FI) of TMC435
Zeitfenster: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
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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.
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Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
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Area Under the Plasma Concentration-time Curve From the Time of Administration up to 24 Hours After Dosing (AUC24h) of TMC435
Zeitfenster: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
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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.
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Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
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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
Zeitfenster: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
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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.
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Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
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Elimination Rate Constant of TMC435
Zeitfenster: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
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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.
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Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
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Terminal Elimination Half-life (t1/2,Term) of TMC435
Zeitfenster: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
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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.
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Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. März 2009
Primärer Abschluss (Tatsächlich)
1. November 2009
Studienabschluss (Tatsächlich)
1. November 2009
Studienanmeldedaten
Zuerst eingereicht
18. Dezember 2008
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
18. Dezember 2008
Zuerst gepostet (Schätzen)
22. Dezember 2008
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
28. Juli 2014
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
1. Juli 2014
Zuletzt verifiziert
1. Juli 2014
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- RNA-Virusinfektionen
- Viruserkrankungen
- Infektionen
- Durch Blut übertragene Infektionen
- Übertragbare Krankheiten
- Leberkrankheiten
- Flaviviridae-Infektionen
- Hepatitis, viral, menschlich
- Enterovirus-Infektionen
- Picornaviridae-Infektionen
- Hepatitis
- Hepatitis A
- Hepatitis C
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antiinfektiva
- Antivirale Mittel
- Enzym-Inhibitoren
- Protease-Inhibitoren
- Simeprevir
Andere Studien-ID-Nummern
- CR012604
- TMC435350-TiDP16-C202 (Andere Kennung: Tibotec Pharmaceuticals, Ireland)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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