search
Back to results

Continuing Treatment With Pegasys and Copegus

Primary Purpose

Chronic Hepatitis C

Status
Unknown status
Phase
Phase 3
Locations
Hungary
Study Type
Interventional
Intervention
peginterferon alfa-2a
ribavirin
Sponsored by
Májbetegekért Alapítvány
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Szt. László HospitalRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 12, 2006
Last Updated
June 12, 2006
Sponsor
Májbetegekért Alapítvány
Collaborators
Hoffmann-La Roche
search

1. Study Identification

Unique Protocol Identification Number
NCT00336518
Brief Title
Continuing Treatment With Pegasys and Copegus
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Unknown status
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2009 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Májbetegekért Alapítvány
Collaborators
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a
Intervention Type
Drug
Intervention Name(s)
ribavirin
Primary Outcome Measure Information:
Title
Sustained viral response given to continuation or prolongation of combined Pegasys&Copegus treatment
Secondary Outcome Measure Information:
Title
Histological response given to continuation or prolongation of combined Pegasys&Copegus treatment measured by non-invasive methods

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
János Schuller, Dr.
Phone
+36 1 455-8127
First Name & Middle Initial & Last Name or Official Title & Degree
Edit Villert
Phone
+36 1 455-8127
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
János Schuller, Dr.
Organizational Affiliation
Májbetegekért Alapítvány
Official's Role
Principal Investigator
Facility Information:
Facility Name
Szt. László Hospital
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
János Schuller, Dr.
Phone
+36 1 455-8228
First Name & Middle Initial & Last Name & Degree
Edit Villert
Phone
+36 1 455-8228

12. IPD Sharing Statement

Learn more about this trial

Continuing Treatment With Pegasys and Copegus

We'll reach out to this number within 24 hrs