Continuing Treatment With Pegasys and Copegus

NCT ID: NCT00336518

Last Updated: 2006-06-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2009-07-31

Brief 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

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.

Conditions

Chronic Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

peginterferon alfa-2a

Intervention Type: DRUG

ribavirin

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

Májbetegekért Alapítvány

OTHER

Sponsor Role: lead

Principal Investigators

János Schuller, Dr.

Role: PRINCIPAL_INVESTIGATOR

Májbetegekért Alapítvány

Locations

Szt. László Hospital

Budapest, , Hungary

Site Status: RECRUITING

Countries

Hungary

Central Contacts

János Schuller, Dr.

Role: CONTACT

+36 1 455-8127

Edit Villert

Role: CONTACT

+36 1 455-8127

Facility Contacts

János Schuller, Dr.

Role: primary

+36 1 455-8228

Edit Villert

Role: backup

+36 1 455-8228

Other Identifiers

ML 20142

Identifier Type: -

Identifier Source: secondary_id

EuDract: 2005-004531-22

Identifier Type: -

Identifier Source: secondary_id

MBA 1/2005

Identifier Type: -

Identifier Source: org_study_id