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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 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Studietype

Observationeel

Inschrijving (Werkelijk)

158

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 99 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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 uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants Achieving SVR12: Additional Analysis
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

AbbVie

Onderzoekers

  • Studie directeur: Andrey Strugovschikov, MD, AbbVie

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 april 2016

Primaire voltooiing (Werkelijk)

4 juli 2017

Studie voltooiing (Werkelijk)

4 juli 2017

Studieregistratiedata

Eerst ingediend

28 januari 2016

Eerst ingediend dat voldeed aan de QC-criteria

28 januari 2016

Eerst geplaatst (Schatting)

1 februari 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 november 2018

Laatste update ingediend die voldeed aan QC-criteria

18 oktober 2018

Laatst geverifieerd

1 juli 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • P15-743

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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