- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00336518
Continuing Treatment With Pegasys and Copegus
Efficacy and Safety of Continuing for a Total of 48 or Prolonging for a Total of 72 Weeks of Combined Treatment of Patients Receiving Pegasys and Copegus Who Are Biochemical Responders But Virological Non-Responders at Week 12 or Week 24
Primary objective is to measure sustained viral response given to continuation or prolongation of combined Pegasys&Copegus treatment
Secondary objective is to measure histological response given to continuation or prolongation of combined Pegasys&Copegus treatment measured by non-invasive methods
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Prospective, multicentre, randomized, open-label comparative study
According to our national guideline of management of patient with chronic viral hepatitis, patients need to stop therapy if they do not achieve response.
These patients can enter to the study at two time points:
- at week 16, if HCV RNS PCR measured at week 12 is positive and serum ALT > 1ULN, but decreased
- at week 28, if HCV RNS PCR measured at week 24 is still positive, but serum ALT < 2ULN.
Patients are randomized to one of the following arms:
- S (standard) group: Pegasys&Copegus combined therapy 180 mcg/week & weight/based 1000-1200 mg/day for a total of 48 weeks of treatment
- P (prolonged) group: Pegasys&Copegus combined therapy 180 mcg/week & -weight/based 1000-1200 mg/day for a total of 72 weeks of treatment.
After completing treatment period patients enter into a 24-week follow up.
Undersøgelsestype
Tilmelding
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: János Schuller, Dr.
- Telefonnummer: +36 1 455-8127
Undersøgelse Kontakt Backup
- Navn: Edit Villert
- Telefonnummer: +36 1 455-8127
Studiesteder
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-
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Budapest, Ungarn, 1097
- Rekruttering
- Szt. László Hospital
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Kontakt:
- János Schuller, Dr.
- Telefonnummer: +36 1 455-8228
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Kontakt:
- Edit Villert
- Telefonnummer: +36 1 455-8228
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Male and female patients above 18 and below 65 years of age chronically infected with genotype 1 HCV receiving combined Pegasys&Copegus treatment first time in-line with the valid treatment guideline approved by the National Interferon Committee (see attached guideline)
Subgroup 1:
- Positive HCV PCR result at week 12 of the ongoing treatment
- ALT > 1ULN, but the value decreased by week 12
Subgroup 2:
- ALT was normal and PCR was positive at week 12, therefore combined treatment could be continued between week 12 and 24 based on the approved guideline
- Positive HCV RNA PCR at week 24 of the ongoing treatment
- GPT < 2 ULN at week 24 of the ongoing treatment.
Exclusion Criteria:
- Women with ongoing pregnancy or breast feeding
- Therapy with any systemic anti-neoplastic or immunomodulatory treatment at inclusion or within 6 months prior to it
- Any investigational drug usage at inclusion or within 6 weeks prior to it
- Co/infection with hepatitis A, B or HIV
- Any chronic liver disease other than HCV infection
- Sign or symptom of hepatocellular carcinoma
- Decompensated liver disease
- History of depression or any other relevant psychiatric disease which, in the opinion of a psychiatrist or neurologist, contraindicates study therapy
- Uncontrolled thyroid dysfunction
- Severe retinopathy
- Evidence of regular alcohol consumption at inclusion or within 1 year prior to it
- Any side effect probably caused by ongoing combined treatment which, in the opinion of the investigator, contraindicates continuation of the therapy or necessitates dose reduction of any drug in the combination therapy
- Unwillingness to provide informed consent
Subgroup 1:
Laboratory findings at week 16 of the ongoing combined Pegasys&Copegus treatment:
- ANC <1000/mm3
- PLT <75.000/mm3
- hemoglobin <10g/dl
- creatinine >1,5 ULN
Subgroup 2:
Laboratory findings at week 28 of the ongoing combined Pegasys&Copegus treatment:
- ANC <1000/mm3
- PLT <75.000/mm3
- hemoglobin <10g/dl
- creatinine >1,5 ULN
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Sustained viral response given to continuation or prolongation of combined Pegasys&Copegus treatment
|
Sekundære resultatmål
Resultatmål |
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Histological response given to continuation or prolongation of combined Pegasys&Copegus treatment measured by non-invasive methods
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: János Schuller, Dr., Májbetegekért Alapítvány
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- Blodbårne infektioner
- Overførbare sygdomme
- Leversygdomme
- Flaviviridae infektioner
- Hepatitis, viral, menneskelig
- Hepatitis, kronisk
- Hepatitis
- Hepatitis C
- Hepatitis C, kronisk
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Antimetabolitter
- Ribavirin
- Peginterferon alfa-2a
Andre undersøgelses-id-numre
- MBA 1/2005
- ML 20142
- EuDract: 2005-004531-22
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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