Continuing Treatment With Pegasys and Copegus

NCT00336518 | Unknown Phase 3

• 3 other identifiers: MBA 1/2005ML 20142EuDract: 2005-004531-22
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

peginterferon alfa-2a DRUG

ribavirin DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Women with ongoing pregnancy or breast feeding
• 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
• 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

Sponsors & Collaborators

• Májbetegekért Alapítvány: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

Szt. László Hospital

Budapest, 1097, Hungary

RECRUITING

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• János Schuller, Dr.

  Májbetegekért Alapítvány

  PRINCIPAL INVESTIGATOR

Central Study Contacts

János Schuller, Dr.

CONTACT

+36 1 455-8127

Edit Villert

CONTACT

+36 1 455-8127

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 12, 2006
• First Posted: June 13, 2006
• Study Start: June 1, 2006
• Study Completion: July 1, 2009
• Last Updated: June 13, 2006

Record last verified: 2005-08

Locations

HU (1)