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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00474955 |
This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis C and end-stage renal disease, including patients on hemodialysis. Patients will receive PEGASYS at a dose of 180 micrograms weekly; those with a calculated glomerular filtration rate of <15mL/min will receive a reduced dose of 135 micrograms weekly. Following 48 weeks of 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 100-500 individuals.
Condition | Intervention | Phase |
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Hepatitis C, Chronic |
Drug: peginterferon alfa-2a (40KD) [PEGASYS] |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Label Study of the Effect of PEGASYS on Sustained Virological Response in Patients With Chronic Hepatitis C and Chronic Renal Failure |
Estimated Enrollment: | 150 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | September 2012 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: peginterferon alfa-2a (40KD) [PEGASYS]
180 micrograms sc weekly for 48 weeks
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Please reference Study ID Number: ML20434 | 973-235-5000 | |
Contact: or | 800-526-6367 (FOR US ONLY) |
Russian Federation | |
Recruiting | |
MOSCOW, Russian Federation, 123182 | |
Recruiting | |
KHABAROVSK, Russian Federation, 680009 | |
Completed | |
EKATERINBURG, Russian Federation, 620102 | |
Recruiting | |
IRKUTSK, Russian Federation, 664047 | |
Recruiting | |
KHABAROVSK, Russian Federation, 680022 | |
Recruiting | |
ST PETERSBURG, Russian Federation, 191167 | |
Active, not recruiting | |
ST PETERSBURG, Russian Federation, 195067 | |
Recruiting | |
CHITA, Russian Federation, 672090 | |
Not yet recruiting | |
KRASNODAR, Russian Federation, 350086 | |
Completed | |
CHELYABINSK, Russian Federation, 454071 |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | ML20434 |
Study First Received: | May 16, 2007 |
Last Updated: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00474955 History of Changes |
Health Authority: | Russia: Federal Agency of drug quality control |
Interferon-alpha Liver Diseases Renal Insufficiency Hepatitis, Chronic Interferons Kidney Failure, Chronic Hepatitis, Viral, Human Angiogenesis Inhibitors Antiviral Agents Hepatitis |
Virus Diseases Digestive System Diseases Urologic Diseases Renal Insufficiency, Chronic Peginterferon alfa-2a Hepatitis C Kidney Diseases Interferon Alfa-2a Hepatitis C, Chronic Kidney Failure |
Anti-Infective Agents Renal Insufficiency Liver Diseases Flaviviridae Infections Hepatitis, Chronic Antineoplastic Agents Physiological Effects of Drugs Kidney Failure, Chronic Hepatitis, Viral, Human Urologic Diseases Therapeutic Uses Growth Inhibitors Hepatitis C Kidney Diseases |
Angiogenesis Modulating Agents RNA Virus Infections Growth Substances Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Virus Diseases Hepatitis Digestive System Diseases Renal Insufficiency, Chronic Peginterferon alfa-2a Interferon Alfa-2a Hepatitis C, Chronic Kidney Failure |