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Prevention of Disease Progress in Chronic Hepatitis C Patients With Liver Fibrosis (Study P02570AM2)(COMPLETED)

7. marts 2017 opdateret af: Merck Sharp & Dohme LLC

PEG-Intron(TM) Maintenance Therapy vs. an Untreated Control Group for Prevention of Progression of Fibrosis in Adult Subjects With Chronic Hepatitis C With Hepatic Fibrosis (METAVIR Fibrosis Score of F2 or F3), Who Failed Therapy With PEG-Intron Plus REBETOL(R) (in Protocol No. P02370)

The objective of the study is to evaluate the safety and efficacy of PEG-Intron versus no treatment for the prevention of fibrosis progression in adult participants with moderate to severe liver fibrosis secondary to chronic hepatitis C, who failed PEG-Intron plus Rebetol treatment in protocol P02370 (NCT00039871).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

540

Fase

  • Fase 3

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age at entry in study P02370 (NCT00039871) 18-65 years;
  • Nonresponder to PEG-Intron plus Rebetol in study P02370

Exclusion Criteria:

  • Participants who did not participate in the P02370 study.
  • Any medical condition, including but not limited to decompensated liver disease, malignancy or substance abuse, that developed during the P02370 study which could interfere with the participant's participation in and completion of this study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: PEG-Intron (peginterferon alfa-2b) 0.5 µg/kg Weekly (QW)
PEG-Intron 0.5 µg/kg Weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
Biologisk: peginterferon alfa-2b (SCH 54031)
0.5 µg/kg Weekly QW SC for 36 months
Ingen indgriben: Untreated Control

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fibrosis Response Status (ie, Improvement, no Change, or the Worsening of the Fibrosis Score in Participants With Baseline METAVIR Fibrosis Score of F2 or F3).
Tidsramme: Baseline to up to Month-36

Definitions:

Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis).

Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline.

No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score.

Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline.
Baseline to up to Month-36

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Inflammation Response Status (ie, Improvement, no Change, or the Worsening of the METAVIR Activity Score as Compared to Baseline)
Tidsramme: Baseline to up to Month-36

Activity Scoring: A0 (no histological activity), A1 (minimal activity), A2 (moderate activity), A3 (severe activity), A4 (lobular chronic hepatitis).

Changes in liver inflammation defined as follows:

Improved: Participants whose METAVIR activity score at up to Month-36 decreases by 1 or more units compared to baseline.

No Change: Participants whose METAVIR activity score at up to Month-36 is the same as the baseline score.

Worsened: Participants whose METAVIR activity score at up to Month-36 increases by 1 or more units compared to baseline.
Baseline to up to Month-36
Mean Change From Baseline to up to Month-36 in the METAVIR Fibrosis Score (Using a Continuous Scale)
Tidsramme: Baseline to up to Month-36

The change of Metavir Fibrosis Score = Metavir Fibrosis Score at up to Month-36 - Metavir Fibrosis Score at Baseline.

Fibrosis scoring: 0 (no fibrosis), 1 (stellate enlargement of portal tract without septa formation, 2 (enlargement of portal tract with rare septa formation, 3 (numerous septa without cirrhosis), 4 (cirrhosis).
Baseline to up to Month-36
The Number of Participants Whose METAVIR Fibrosis Score Did Not Worsen (ie, the Response Status of Improved/no Change) During Treatment Compared to Baseline
Tidsramme: Baseline to up to Month-36

Definitions:

Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis).

Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline.

No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score.

Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline.
Baseline to up to Month-36
Mean Change in the METAVIR Activity Score (Using a Continuous Scale)
Tidsramme: Baseline to up to Month-36

The change of Metavir Activity Score = Metavir Activity Score at up to Month-36 - Metavir Activity Score at Baseline.

Activity Scoring: 0 (no histological activity), 1 (minimal activity), 2 (moderate activity), 3 (severe activity), 4 (lobular chronic hepatitis).
Baseline to up to Month-36
Number of Participants With no Worsening (ie, the Response Status of Improved/ no Change) in the METAVIR Activity Score During the Treatment.
Tidsramme: Baseline to up to Month-36

Definitions:

Activity Scoring: A0 (no histological activity), A1 (minimal activity), A2 (moderate activity), A3 (severe activity), A4 (lobular chronic hepatitis).

Improved: Participants whose METAVIR activity score at up to Month-36 decreases by 1 or more units compared to baseline.

No Change: Participants whose METAVIR activity score at up to Month-36 is the same as the baseline score.

Worsened: Participants whose METAVIR activity score at up to Month-36 increases by 1 or more units compared to baseline.
Baseline to up to Month-36

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Merck Sharp & Dohme LLC

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2002

Primær færdiggørelse (Faktiske)

1. oktober 2009

Studieafslutning (Faktiske)

1. oktober 2009

Datoer for studieregistrering

Først indsendt

14. november 2002

Først indsendt, der opfyldte QC-kriterier

14. november 2002

Først opslået (Skøn)

15. november 2002

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. marts 2017

Sidst verificeret

1. marts 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P02570

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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