Continuing Treatment With Pegasys and Copegus

• Status: Unknown status
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Májbetegekért Alapítvány
• Collaborator: Hoffmann-La Roche
• Treatments: Peginterferon alfa-2a; Ribavirin

Criteria

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