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Sponsored by: |
Hoffmann-La Roche |
---|---|
Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00560274 |
This single arm study will assess the safety of NeoRecormon in the correction of anemia in patients with chronic hepatitis C who are being treated with Pegylated interferon + ribavirin combination therapy. Patients will receive NeoRecormon at a starting dose of 30,000 IU s.c. which will be adjusted as required to maintain a target Hb of 11-13g/dL. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.
Condition | Intervention | Phase |
---|---|---|
Anemia |
Drug: epoetin beta [NeoRecormon] Drug: Pegasys Drug: Ribavirin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Label Study to Evaluate the Safety of NeoRecormon in the Treatment of Anemia in Patients With Chronic Hepatitis C Who Are Treated With Pegylated Interferon + Ribavirin Combination Therapy |
Estimated Enrollment: | 200 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | December 2010 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: epoetin beta [NeoRecormon]
30,000 IU sc/week (starting dose)
Drug: Pegasys
As prescribed
Drug: Ribavirin
As prescribed
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Please reference Study ID Number: ML21362 | 973-235-5000 | |
Contact: or | 800-526-6367 (FOR US ONLY) |
France | |
Recruiting | |
CRETEIL, France, 94010 | |
Recruiting | |
CLICHY, France, 92118 | |
Recruiting | |
SAINT LAURENT DU VAR, France, 06700 | |
Recruiting | |
TOULOUSE, France, 31059 | |
Recruiting | |
PESSAC, France, 33604 | |
Recruiting | |
NICE, France, 06202 | |
Recruiting | |
MARSEILLE, France, 13285 | |
Recruiting | |
MARSEILLE, France, 13385 | |
Recruiting | |
STRASBOURG, France, 67091 | |
Recruiting | |
TOURCOING, France, 59208 | |
Recruiting | |
BESANCON, France, 25030 | |
Recruiting | |
PARIS, France, 75651 | |
Recruiting | |
PARIS, France, 75970 | |
Recruiting | |
MONTPELLIER, France, 34295 | |
Recruiting | |
RENNES, France, 35033 | |
Recruiting | |
VANDOEUVRE-LES-NANCY, France, 54511 | |
Recruiting | |
LYON, France, 69437 | |
Recruiting | |
CRETEIL, France, 94000 | |
Recruiting | |
ANGERS, France, 49933 | |
Recruiting | |
LIMOGES, France, 87042 | |
Recruiting | |
CHAMBRAY-LÈS-TOURS, France, 37044 | |
Recruiting | |
CAEN, France, 14033 | |
Recruiting | |
ROUEN, France, 76031 | |
Recruiting | |
VILLEJUIF, France, 94804 |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | ML21362 |
Study First Received: | November 16, 2007 |
Last Updated: | August 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00560274 History of Changes |
Health Authority: | France:Agence francaise de securite sanitaire des produits de sante (AFSSAPS) |
Antimetabolites Epoetin Alfa Anti-Infective Agents Liver Diseases Hepatitis, Chronic Hematologic Diseases Ribavirin Interferons Anemia |
Hepatitis, Viral, Human Antiviral Agents Hepatitis Virus Diseases Digestive System Diseases Peginterferon alfa-2a Hepatitis C Hepatitis C, Chronic |
Antimetabolites Anti-Infective Agents Liver Diseases RNA Virus Infections Molecular Mechanisms of Pharmacological Action Hepatitis, Chronic Flaviviridae Infections Hematologic Diseases Ribavirin Anemia |
Hepatitis, Viral, Human Antiviral Agents Pharmacologic Actions Hepatitis Virus Diseases Digestive System Diseases Therapeutic Uses Hepatitis C Hepatitis C, Chronic |