A Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Chronic Hepatitis C. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00560274

Purpose

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

MedlinePlus related topics: Anemia Hepatitis Hepatitis C

Drug Information available for: Epoetin alfa Erythropoietin Ribavirin Peginterferon Alfa-2a Epoetin beta Interferons

U.S. FDA Resources

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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Blood pressure, pulse rate. [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
AEs, and laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of patients achieving correction of anemia [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Percentage of patients not requiring blood transfusion [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Course of Hb concentration [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Percentage of patients maintaining initial ribavirin dose [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	March 2008
Estimated Study Completion Date:	March 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients, >=18 years of age;
chronic hepatitis C;
quantifiable serum HCV RNA;
Pegylated interferon + ribavirin treatment started <6 months before study;
Hb <10g/dL.

Exclusion Criteria:

treatment with ESA during preceding 12 weeks;
poorly controlled hypertension;
history of cancer, except for basal cell cancer and cervical cancer in situ.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560274

Contacts

Contact: Please reference Study ID Number: ML21362	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

France
	Active, not recruiting
CRETEIL, France, 94010
	Active, not recruiting
CLICHY, France, 92118
	Active, not recruiting
SAINT LAURENT DU VAR, France, 06700
	Active, not recruiting
TOULOUSE, France, 31059
	Active, not recruiting
PESSAC, France, 33600
	Active, not recruiting
NICE, France, 06202
	Active, not recruiting
MARSEILLE, France, 13285
	Active, not recruiting
MARSEILLE, France, 13385
	Active, not recruiting
STRASBOURG, France, 67091
	Active, not recruiting
TOURCOING, France, 59208
	Active, not recruiting
BESANCON, France, 25030
	Active, not recruiting
PARIS, France, 75651
	Recruiting
PARIS, France, 75970
	Active, not recruiting
MONTPELLIER, France, 34295
	Active, not recruiting
RENNES, France, 35033
	Active, not recruiting
VANDOEUVRE-LES-NANCY, France, 54511
	Active, not recruiting
LYON, France, 69437
	Active, not recruiting
CRETEIL, France, 94000
	Recruiting
ANGERS, France, 49933
	Recruiting
LIMOGES, France, 87042
	Recruiting
CHAMBRAY-LÈS-TOURS, France, 37044
	Recruiting
CAEN, France, 14033
	Not yet recruiting
ROUEN, France, 76031
	Active, not recruiting
VILLEJUIF, France, 94804

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML21362
Study First Received:	November 16, 2007
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00560274
Health Authority:	France:Agence francaise de securite sanitaire des produits de sante (AFSSAPS)

Study placed in the following topic categories:

Epoetin Alfa
Liver Diseases
Hepatitis, Chronic
Hematologic Diseases
Ribavirin
Interferons
Anemia

Hepatitis, Viral, Human
Hepatitis
Virus Diseases
Digestive System Diseases
Peginterferon alfa-2a
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action

Flaviviridae Infections
Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009