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 - ProPeg

• Conditions: Chronic hepatitis C virus infection

• Registration Number: EUCTR2005-004531-22-HU
• Lead Sponsor: Májbetegekért Alapítvány

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Sustained viral response given to continuation or prolongation of combined Pegasys&Copegus treatment;Main Objective: Sustained viral response given to continuation or prolongation of combined Pegasys&Copegus treatment;Secondary Objective: Histological response given to continuation or prolongation of combined Pegasys&Copegus treatment measured by non-invasive methods