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Observational, Multi-Center Study of the Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in the Russian Federation (HCV RWE)

18. Oktober 2018 aktualisiert von: AbbVie

Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in the Russian Federation - An Observational, Multi-Center Study

This study seeks to assess the effectiveness, patient reported outcomes, work productivity and healthcare resource utilization of the interferon-free regimen of paritaprevir /ritonavir (r) - ombitasvir, ± dasabuvir ± ribavirin (RBV) in participants with chronic hepatitis C in a real life setting across clinical practice populations.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

158

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 99 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C genotype 1, receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label.

Beschreibung

Inclusion Criteria:

Patients are eligible for observation in this cohort if the following applies:

  • Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype 1, receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label
  • If RBV is co-administered with paritaprevir/r - ombitasvir with or without dasabuvir, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
  • Patients must voluntarily sign and date informed consent prior to inclusion into the study

Exclusion Criteria:

  • Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Participants With Chronic Hepatitis C Genotype 1
Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12)
Zeitfenster: 12 weeks after the last actual dose of study drug
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels < 50 IU/mL 12 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.
12 weeks after the last actual dose of study drug

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse
Zeitfenster: 12 weeks after last actual dose of study drug
Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment. Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL. Relapse is defined as HCV RNA < 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL posttreatment.
12 weeks after last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Breakthrough
Zeitfenster: 12 weeks after the last actual dose of study drug
Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment.
12 weeks after the last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Failure to Suppress
Zeitfenster: 12 weeks after the last actual dose of study drug
Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL.
12 weeks after the last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Relapse
Zeitfenster: 12 weeks after last actual dose of study drug
Relapse is defined as HCV RNA <50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL posttreatment.
12 weeks after last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure
Zeitfenster: 12 weeks after last actual dose of study drug
On-treatment virologic failure included virological breakthrough and failure to suppress. Virological breakthrough was defined as at least one documented HCV RNA < 50 IU/mL or undetectable/negative followed by HCV RNA ≥ 50 IU/mL during treatment. Failure to suppress was defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive.
12 weeks after last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Missing SVR12 Data
Zeitfenster: 12 weeks after last actual dose of study drug
12 weeks after last actual dose of study drug
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)
Zeitfenster: 24 weeks after last actual dose of study drug
SVR24 is defined as HCV RNA levels < 50 IU/mL 24 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.
24 weeks after last actual dose of study drug
Percentage of Participants Achieving Virological Response at End of Treatment
Zeitfenster: From baseline until end of treatment (12 or 24 weeks after actual first dose)
Virologic response is defined as HCV RNA < 50 IU/mL.
From baseline until end of treatment (12 or 24 weeks after actual first dose)

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants Achieving SVR12: Additional Analysis
Zeitfenster: 12 weeks after the last actual dose of study drug
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels < 50 IU/mL or undetectable/negative 12 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.
12 weeks after the last actual dose of study drug
Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse: Additional Analysis
Zeitfenster: 12 weeks after last actual dose of study drug
Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL or undetectable/negative followed by HCV RNA ≥50 IU/mL or positive during treatment. Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive. Relapse is defined as HCV RNA < 50 IU/mL or undetectable/negative at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL or positive posttreatment.
12 weeks after last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Breakthrough: Additional Analysis
Zeitfenster: 12 weeks after the last actual dose of study drug
Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL or undetectable/negative followed by HCV RNA ≥50 IU/mL or positive during treatment.
12 weeks after the last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Failure to Suppress: Additional Analysis
Zeitfenster: 12 weeks after the last actual dose of study drug
Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive.
12 weeks after the last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Relapse: Additional Analysis
Zeitfenster: 12 weeks after last actual dose of study drug
Relapse is defined as HCV RNA < 50 IU/mL or undetectable/negative at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL or positive posttreatment.
12 weeks after last actual dose of study drug
Percentage of Participants Achieving SVR24: Additional Analysis
Zeitfenster: 24 weeks after last actual dose of study drug
SVR24 is defined as HCV RNA levels < 50 IU/mL or undetectable/negative 24 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.
24 weeks after last actual dose of study drug
Percentage of Participants Achieving Virological Response at End of Treatment: Additional Analysis
Zeitfenster: From baseline until end of treatment (12 or 24 weeks after actual first dose)
Virologic response is defined as HCV RNA < 50 IU/mL or undetectable/negative.
From baseline until end of treatment (12 or 24 weeks after actual first dose)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

AbbVie

Ermittler

  • Studienleiter: Andrey Strugovschikov, MD, AbbVie

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

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 (Tatsächlich)

15. April 2016

Primärer Abschluss (Tatsächlich)

4. Juli 2017

Studienabschluss (Tatsächlich)

4. Juli 2017

Studienanmeldedaten

Zuerst eingereicht

28. Januar 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. Januar 2016

Zuerst gepostet (Schätzen)

1. Februar 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. November 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. Oktober 2018

Zuletzt verifiziert

1. Juli 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • P15-743

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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