Continuing Treatment With Pegasys and Copegus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00336518|
Recruitment Status : Unknown
Verified August 2005 by Májbetegekért Alapítvány.
Recruitment status was: Recruiting
First Posted : June 13, 2006
Last Update Posted : June 13, 2006
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 or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C||Drug: peginterferon alfa-2a Drug: ribavirin||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||June 2006|
|Estimated Study Completion Date :||July 2009|
- Sustained viral response given to continuation or prolongation of combined Pegasys&Copegus treatment
- Histological response given to continuation or prolongation of combined Pegasys&Copegus treatment measured by non-invasive methods
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00336518
|Contact: János Schuller, Dr.||+36 1 455-8127|
|Contact: Edit Villert||+36 1 455-8127|
|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|