Randomized, Multicenter, Double-Blinded, Phase IV Study Evaluating the Efficacy (as measured by Sustained Virological Response) and Safety of 360 µg Induction Dosing of Pegasys in Combination with Higher Copegus Doses in Treatment-naïve Patients with Chronic Hepatitis C Genotype 1 Virus Infection of High Viral Titer and Baseline Body Weight Greater than or Equal to 85 kg - PROGRESS

F. Hoffmann-La Roche Ltd0 sites1,140 target enrollmentOctober 6, 2006

Conditionsgenotype 1 chronic hepatitis C infection of high viral titer and baseline body weight greater than or equal to 85 kg MedDRA version: 8.1Level: LLTClassification code 10008912Term: Chronic hepatitis C

DrugsPegasys Copegus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: genotype 1 chronic hepatitis C infection of high viral titer and baseline body weight greater than or equal to 85 kg
Sponsor: F. Hoffmann-La Roche Ltd
Enrollment: 1140
Status: Active, not recruiting
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 6, 2006

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

F. Hoffmann-La Roche Ltd

Eligibility Criteria

Inclusion Criteria

•To be eligible for this trial, patients must have documentation of the following:
•Age \>\=18 years
•Body weight \>\= 85 kg
•Serologic evidence of CHC infection by an anti\-HCV antibody test (current or historical)
•Evidence of hepatitis C genotype 1 infection by molecular assay
•Serum HCV RNA quantifiable at \>\= 400,000 IU/mL by the Roche TaqMan HCV Test
•Chronic liver disease consistent with CHC infection on a biopsy obtained within the past 24 calendar months as judged by a central pathologist. For patients with incomplete/transition to cirrhosis or cirrhosis, a biopsy within 36 calendar months before the first dose is sufficient. A maximum of 20% of patients with cirrhosis or incomplete/transition to cirrhosis will be permitted to enroll in the trial.
•Patients with cirrhosis or incomplete/transition to cirrhosis must have an abdominal ultrasound, computerized tomographic (CT) scan, or magnetic resonance imaging (MRI) scan without evidence of hepatocellular carcinoma (within 2 months prior to randomization) and a serum alpha\-fetoprotein (AFP) \<100 ng/mL
•Compensated liver disease (Child\-Pugh Grade A clinical classification only)
•Negative urine pregnancy test result (for females of childbearing potential) documented within the 24\-hour period prior to the first dose of study drugs. Additionally, all female patients of childbearing potential and all males with female partners of childbearing potential must use two forms of effective contraception (combined) during treatment and 6 months after treatment end

Exclusion Criteria

•Patients with any of the following will not be eligible for participation:
•Infection with HCV genotype 1 mixed with a genotype other than genotype 2 or genotype 3 or infection with an indeterminate genotype. Patients with indeterminate or mixed genotype 1 subtypes will be allowed.
•History of having received interferon alpha (IFN), PEG\-IFN, ribavirin, viramidine, levovirin, or investigational HCV protease or polymerase inhibitors at any previous time, or any other systemic antiviral therapy with established or perceived activity against the hepatitis C virus \=\<3 months prior to the first dose of study drug
•History of having received any investigational drug \=\< 3 months prior to the first dose of study drug or the expectation that such drugs will be used during the study. Patients enrolled in this study cannot be enrolled in another study for either research, diagnostic or treatment purposes.
•Patients who are expected to need systemic antiviral therapy with established or perceived activity against HCV at any time during their participation in the study are also excluded
•Positive test at screening for anti\-HAV IgM Ab, HBsAg, anti\-HBc IgM Ab, or anti\-HIV Ab • History or other evidence of a medical condition associated with chronic liver disease other than CHC (eg, hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures) • Females who are pregnant or breast\-feeding
•Male partners of females who are pregnant
•Absolute neutrophil count (ANC) \<1500 cells/mm3
•Platelet count \<90,000 cells/mm3
•Hemoglobin concentration \<12 g/dL in females or \<13 g/dL in males or any patient with a baseline increased risk for anemia (eg, thalassemia, sickle cell anemia, spherocytosis, history of gastrointestinal bleeding) or for whom anemia would be medically problematic