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Safety and Efficacy of PegIntron Plus Rebetol in Patients With Chronic Hepatitis C in Japan, Excluding (1) Subjects With HCV Genotype 1 and High Viral Load, and (2) Interferon-naïve Subjects With Low Viral Load (Study P04841)(COMPLETED)

2. februar 2015 oppdatert av: Merck Sharp & Dohme LLC

PegIntron/REBETOL Combination Therapy Designated Drug Use Investigation -Investigation on the Safety and Efficacy of PegIntron and REBETOL Combination Therapy in Patients With Chronic Hepatitis C Excluding Those With "IFN Naive Low Viral Load and Genotype 1 and High Viral Load"-

The objective of the study is to evaluate the safety and efficacy of PegIntron plus Rebetol combination therapy administered to patients with chronic hepatitis C. The study will exclude (1) subjects with HCV genotype 1 and high viral load, and (2) interferon-naïve subjects with low viral load. It is being conducted as a post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's guideline on Good Post-marketing Study Practice.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Faktiske)

505

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients with chronic hepatitis C excluding subjects with HCV genotype 1 and high viral load, and interferon-naïve subjects with low viral load. Patients undergoing treatment with PegIntron and Rebetol in clinical practice at approximately 50 to 100 sites in Japan.

Beskrivelse

Inclusion Criteria:

  • Patients diagnosed with chronic hepatitis C
  • Among interferon-naïve patients, only patients with high viral load and HCV genotype other than 1
  • Among prior nonresponders or relapsers to interferon monotherapy, (1) patients with high viral load and HCV genotype other than 1; and (2) patients with low viral load of all genotypes (including genotype 1)

Exclusion Criteria:

  • Patients infected with HCV genotype 1 with high viral load, regardless of whether treatment-naïve or previous nonresponders/relapsers
  • Interferon-naïve patients with low viral load
  • Patients with a history of hypersensitivity to test drugs or other interferon preparations
  • Patients with a history of hypersensitivity to biological products, such as vaccines
  • Patients being treated with Shosaikoto
  • Patients with autoimmune hepatitis
  • Pregnant women, women who may be pregnant, and nursing mothers
  • Patients with a history of hypersensitivity to any component of this drug or other nucleoside analogs (aciclovir, ganciclovir, vidarabine, etc.)
  • Patients with difficult-to-control cardiac disease (eg, myocardial infarction, cardiac failure, arrhythmia)
  • Patients with hemoglobinopathies (eg, thalassemia, sickle-cell anemia)
  • Patients with chronic renal failure or renal function disorder with creatinine clearance of <=50 mL/min
  • Patients with or a history of severe psychiatric condition such as severe depression, suicidal ideation or suicide attempt
  • Patients with serious hepatic dysfunction
  • Patients with autoimmune hepatitis

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Arm 1
Overall study population.
Legemiddel: PegIntron (peginterferon alfa-2b; SCH 54031)

PegIntron administered in accordance with approved labeling

Subcutaneous injection once weekly for 24 weeks.

Andre navn:
  • SCH 54031
Legemiddel: Rebetol (ribavirin; SCH 18908)
Rebetol administered orally twice daily in accordance with approved labeling. Dosing duration 24 weeks.
Andre navn:
  • SCH 18908

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Overall incidence of adverse events and adverse drug reactions.
Tidsramme: Assessed from the time the informed consent is signed up until 30 days after completion or discontinuation from the study
Assessed from the time the informed consent is signed up until 30 days after completion or discontinuation from the study
Assessment of trends of adverse drug reactions by patient factors and concomitant medications; Incidence, severity, and outcome of adverse events (AEs) between the elderly vs younger patients
Tidsramme: Assessed from the time the informed consent is signed up until 30 days after completion or discontinuation from the study
Assessed from the time the informed consent is signed up until 30 days after completion or discontinuation from the study
Sustained virologic response rate by HCV genotype, baseline viral load, and patient demographic characteristics
Tidsramme: Assessed at 24 weeks post-treatment
Assessed at 24 weeks post-treatment

Sekundære resultatmål

Resultatmål
Tidsramme
Rate of ALT normalization at end of treatment period and at 24 weeks post completing therapy.
Tidsramme: End of treatment and 24 weeks after end of treatment
End of treatment and 24 weeks after end of treatment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Merck Sharp & Dohme LLC

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2006

Primær fullføring (Faktiske)

1. desember 2008

Studiet fullført (Faktiske)

1. desember 2008

Datoer for studieregistrering

Først innsendt

25. juli 2008

Først innsendt som oppfylte QC-kriteriene

25. juli 2008

Først lagt ut (Anslag)

29. juli 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

3. februar 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. februar 2015

Sist bekreftet

1. februar 2015

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • P04841

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Hepatitt C

Kliniske studier på PegIntron (peginterferon alfa-2b; SCH 54031)

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Malawi

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
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