| October 30, 2006 |
| September 16, 2009 |
| February 2007 |
| |
| SVR [ Time Frame: Week 72 ] [ Designated as safety issue: No ] |
| Sustained virological response (SVR) at week 72. |
| Complete list of historical versions of study NCT00394277 on ClinicalTrials.gov Archive Site |
- SVR [ Time Frame: 24 weeks after end of treatment ] [ Designated as safety issue: No ]
- Virological response [ Time Frame: Week 48 and 60, and 12 weeks after end of treatment ] [ Designated as safety issue: No ]
- AEs, laboratory parameters, Beck Depression Inventory [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
|
| Efficacy: SVR at 24 weeks after end of treatment; virological response at week 48, week 60, at end of treatment, and 12 weeks after end of treatment. Safety: AEs, lab parameters, Beck Depression Inventory. |
| |
| A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C. |
| A Randomized, Double-blind Study of the Effect on Sustained Viral Response, and the Safety, of Standard or 360 ug PEGASYS Induction Dosing in Combination With Standard or Higher Dose Copegus in Treatment-naive Chronic Hepatitis C Patients Weighing >85kg With Genotype 1 High Viral Titer Infection |
This 4 arm study will compare the efficacy and safety of PEGASYS induction and maintenance dosing, versus standard fixed dosing in combination with Copegus,and the efficacy and safety of higher dose versus standard dose Copegus in combination with PEGASYS. Patients with chronic hepatitis C genotype 1 infection of high viral titer, and baseline body weight >=85kg, will be randomized to one of 4 groups, to receive a)PEGASYS 180 micrograms sc weekly plus Copegus 1200mg po daily, b)PEGASYS 180 micrograms sc weekly plus Copegus 1400-1600mg po daily, c)PEGASYS 360 micrograms sc weekly (induction) followed by 180 micrograms sc weekly (maintenance) plus Copegus 1200mg po daily or d)PEGASYS 360 micrograms sc weekly (induction) followed by 180 micrograms sc weekly (maintenance) plus Copegus 1400-1600mg po daily. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals. |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Hepatitis C, Chronic |
- Drug: peginterferon alfa-2a (40KD) [PEGASYS]
- Drug: Copegus
|
| |
| |
| |
| Active, not recruiting |
| 1175 |
| March 2009 |
|
Inclusion Criteria:
- adult patients, >=18 years of age;
- CHC infection, genotype 1;
- HCV RNA >=400,000 IU/mL;
- baseline body weight >=85kg;
- liver biopsy (within 24 months of first dose) with results consistent with CHC.
Exclusion Criteria:
- previous treatment with interferon, ribavirin, viramidine, levovirin, HCV polymerase or protease inhibitors;
- other forms of liver disease, including liver cancer;
- human immunodeficiency virus infection.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Belgium, Brazil, Canada, Denmark, France, Germany, Hungary, Netherlands, Poland, Puerto Rico, Romania, Russian Federation, Sweden, United Kingdom |
| |
| NCT00394277 |
| Clinical Trials, Study Director, Hoffmann-La Roche |
| NV18210 |
| Hoffmann-La Roche |
|
| Study Director: |
Clinical Trials |
Hoffmann-La Roche, +1 973 235 5000 |
|
|
| Hoffmann-La Roche |
| September 2009 |
