| February 10, 2004 |
| May 13, 2009 |
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| |
| Viral response compared to baseline [ Time Frame: Week 24 ] [ Designated as safety issue: No ] |
| Efficacy: viral response from baseline to Week 24 |
| Complete list of historical versions of study NCT00077649 on ClinicalTrials.gov Archive Site |
- SVR and end of treatment virological response [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
- Virological response [ Time Frame: Week 60 ] [ Designated as safety issue: No ]
- AEs, laboratory parameters, vital signs, Beck Depression Inventory [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
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| Efficacy: Sustained virologic response, EOT virological response, virologic response at 12 weeks post- treatment
Safety: Vital signs, laboratory tests, clinical adverse events, Beck Depression Inventory |
| |
| A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC). |
| A Randomized, Double-Blind Study of the Effect of PEGASYS and Ribavirin Combination Therapy on Viral Kinetics and Virologic Response in Interferon-naïve Patients With Chronic Hepatitis C Genotype 1 Infection |
The effects of treatment with different doses of PEGASYS in combination with different doses of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer, body weight greater than 85kg (187lbs) and no prior treatment with interferon. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 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
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| |
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| Completed |
| 188 |
| April 2006 |
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Inclusion Criteria:
- adult patients >=18 years of age;
- body weight >85kg (187lbs);
- CHC (genotype 1);
- liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection;
- use of 2 forms of contraception during study and 6 months after the study in both men and women.
Exclusion Criteria:
- women who are pregnant or breastfeeding;
- male partners of women who are pregnant;
- conditions associated with decompensated liver disease;
- other forms of liver disease, including liver cancer;
- human immunodeficiency virus infection;
- previous treatment with an interferon, ribavirin, viramidine, levovirin or amantadine.
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| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Puerto Rico |
| |
| NCT00077649 |
| Clinical Trials, Study Director, Hoffmann-La Roche |
| NV17318 |
| Hoffmann-La Roche |
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| Study Director: |
Clinical Trials |
Hoffmann-La Roche, +1 973 235 5000 |
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|
| Hoffmann-La Roche |
| May 2009 |
