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

Study Overview

• Status: Unknown
• Conditions: Chronic Hepatitis C
• Intervention / Treatment: Drug: ribavirin; Drug: peginterferon alfa-2a

Detailed Description

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.

• Study Type: Interventional
• Enrollment: 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: János Schuller, Dr.; Phone Number: +36 1 455-8127
• Study Contact Backup: Name: Edit Villert; Phone Number: +36 1 455-8127

Study Locations

• Hungary
  • Budapest, Hungary, 1097
    • Recruiting
    • Szt. László Hospital
    • Contact: János Schuller, Dr.; Phone Number: +36 1 455-8228
    • Contact: Edit Villert; Phone Number: +36 1 455-8228

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Sustained viral response given to continuation or prolongation of combined Pegasys&Copegus treatment

Secondary Outcome Measures

Outcome Measure
Histological response given to continuation or prolongation of combined Pegasys&Copegus treatment measured by non-invasive methods

Collaborators and Investigators

• Sponsor: Májbetegekért Alapítvány
• Collaborators: Hoffmann-La Roche
• Investigators: Principal Investigator: János Schuller, Dr., Májbetegekért Alapítvány

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Study Completion: July 1, 2009

Study Registration Dates

• First Submitted: June 12, 2006
• First Submitted That Met QC Criteria: June 12, 2006
• First Posted (Estimate): June 13, 2006

Study Record Updates

• Last Update Posted (Estimate): June 13, 2006
• Last Update Submitted That Met QC Criteria: June 12, 2006
• Last Verified: August 1, 2005

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Hepatitis C; Hepatitis C, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Ribavirin; Peginterferon alfa-2a
• Other Study ID Numbers: MBA 1/2005; ML 20142; EuDract: 2005-004531-22