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Sponsors and Collaborators: |
Májbetegekért Alapítvány Hoffmann-La Roche |
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Information provided by: | Májbetegekért Alapítvány |
ClinicalTrials.gov Identifier: | NCT00336518 |
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
Condition | Intervention | Phase |
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Chronic Hepatitis C |
Drug: peginterferon alfa-2a Drug: ribavirin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 100 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | July 2009 |
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:
Patients are randomized to one of the following arms:
After completing treatment period patients enter into a 24-week follow up.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Subgroup 2:
Exclusion Criteria:
Subgroup 1:
Laboratory findings at week 16 of the ongoing combined Pegasys&Copegus treatment:
Subgroup 2:
Laboratory findings at week 28 of the ongoing combined Pegasys&Copegus treatment:
Contact: János Schuller, Dr. | +36 1 455-8127 | |
Contact: Edit Villert | +36 1 455-8127 |
Hungary | |
Szt. László Hospital | Recruiting |
Budapest, Hungary, 1097 | |
Contact: János Schuller, Dr. +36 1 455-8228 | |
Contact: Edit Villert +36 1 455-8228 |
Principal Investigator: | János Schuller, Dr. | Májbetegekért Alapítvány |
Study ID Numbers: | MBA 1/2005, ML 20142, EuDract: 2005-004531-22 |
Study First Received: | June 12, 2006 |
Last Updated: | June 12, 2006 |
ClinicalTrials.gov Identifier: | NCT00336518 |
Health Authority: | Hungary: National Institute of Pharmacy |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic |
Ribavirin Peginterferon alfa-2a Hepatitis, Viral, Human Hepatitis C Hepatitis C, Chronic |
Anti-Infective Agents RNA Virus Infections Flaviviridae Infections |
Therapeutic Uses Antiviral Agents Pharmacologic Actions |