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A Quality of Life Study of Peginterferon-Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C and Persistently Normal Alanine Transaminase (ALT) Levels

5. Juli 2016 aktualisiert von: Hoffmann-La Roche

A Quality of Life Study of PEGASYS® (Peginterferon-Alfa2a) in Combination With COPEGUS® (Ribavirin) in Patients With Chronic Hepatitis C and Persistently Normal ALT Levels

Participants with Chronic Hepatitis C (CHC) and normal ALT, who have been under treatment with peginterferon alfa-2a and ribavirin for at least 4 weeks, will be enrolled into this non-interventional, open-label study. The primary aim is to evaluate quality of life according to the 36-Item Short-Form Health Survey (SF-36) questionnaire, modified for the Greek population.

Studienübersicht

Status

Abgeschlossen

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

114

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

      • Aigaleo - Attiki, Griechenland, 12241
      • Athens, Griechenland, 115 27
      • Athens, Griechenland, 11527
      • Athens, Griechenland, 11528
      • Athens, Griechenland, 11522
      • Athens, Griechenland, 11526
      • Heraklion, Griechenland, 71100
      • Piraeus, Griechenland, 18536
      • Piraeus, Griechenland, 18454
      • Thessaloniki, Griechenland, 546 42

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 und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Participants with CHC and persistently normal ALT levels who have been receiving peginterferon alfa-2a and ribavirin for at least 4 weeks.

Beschreibung

Inclusion Criteria:

  • Serological confirmation of chronic infection by anti-hepatitis C virus (HCV) assay
  • HCV ribonucleic acid (RNA) positive
  • CHC with normal transaminases
  • Compensated liver disease
  • Non-pregnant and willing to use two contraceptive methods (if fertile)
  • At least 4 weeks of prior treatment with peginterferon alfa-2a and ribavirin

Exclusion Criteria:

  • Pregnant or lactating women
  • Co-infection with hepatitis A or B, or human immunodeficiency virus (HIV)
  • History of seizures or depression
  • History of autoimmune disease, severe heart or lung disease, or renal failure with reduced creatinine clearance
  • Uncontrolled thyroid disease
  • Severe retinopathy
  • Leukopenia or thrombocytopenia
  • Bleeding esophageal varices or other evidence of hepatic decompensation

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
Intervention / Behandlung
Chronic Hepatitis C Participants
Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, will be observed up to 24 weeks after end of treatment (EOT) (up to 72 weeks). Peg-interferon alfa-2a and ribavirin will be administered as per treating physician discretion and according to summary of product characteristics.
As per treating physician discretion and according to summary of product characteristics.
Andere Namen:
  • Pegasys
As per treating physician discretion and according to summary of product characteristics.
Andere Namen:
  • Copegus

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT)
Zeitfenster: Baseline, EOT (up to 48 weeks)
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).
Baseline, EOT (up to 48 weeks)
Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT
Zeitfenster: Baseline, 24 weeks after EOT (up to 72 weeks)
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).
Baseline, 24 weeks after EOT (up to 72 weeks)
Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT
Zeitfenster: Baseline, EOT (up to 48 weeks)
SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).
Baseline, EOT (up to 48 weeks)
Change From Baseline in SF-36 PCS at 24 Weeks After EOT
Zeitfenster: Baseline, 24 weeks after EOT (up to 72 weeks)
SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).
Baseline, 24 weeks after EOT (up to 72 weeks)
Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT
Zeitfenster: Baseline, EOT (up to 48 weeks)
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning).
Baseline, EOT (up to 48 weeks)
Change From Baseline in SF-36 MCS at 24 Weeks After EOT
Zeitfenster: Baseline, 24 weeks after EOT (up to 72 weeks)
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning).
Baseline, 24 weeks after EOT (up to 72 weeks)

Mitarbeiter und Ermittler

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

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. Februar 2007

Primärer Abschluss (Tatsächlich)

1. Juli 2011

Studienabschluss (Tatsächlich)

1. Juli 2011

Studienanmeldedaten

Zuerst eingereicht

29. März 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. März 2016

Zuerst gepostet (Schätzen)

1. April 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

15. August 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. Juli 2016

Zuletzt verifiziert

1. April 2016

Mehr Informationen

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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