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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00560274
Recruitment Status : Completed
First Posted : November 19, 2007
Last Update Posted : February 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Anemia Drug: Pegasys Drug: Ribavirin Drug: epoetin beta [NeoRecormon] Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2008
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Pegasys
As prescribed
Drug: Ribavirin
As prescribed
Drug: epoetin beta [NeoRecormon]
30,000 IU sc/week (starting dose)

Primary Outcome Measures :
  1. Blood pressure, pulse rate. [ Time Frame: 6 and 12 months ]
  2. AEs, and laboratory parameters. [ Time Frame: Throughout study ]

Secondary Outcome Measures :
  1. Percentage of patients achieving correction of anemia [ Time Frame: 3 months ]
  2. Percentage of patients not requiring blood transfusion [ Time Frame: 12 months ]
  3. Course of Hb concentration [ Time Frame: 12 months ]
  4. Percentage of patients maintaining initial ribavirin dose [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00560274

Angers, France, 49933
Besancon, France, 25030
Caen, France, 14033
Chambray Les Tours, France, 37171
Clichy, France, 92118
Creteil, France, 94000
Creteil, France, 94010
Limoges, France, 87042
Lyon, France, 69437
Marseille, France, 13285
Marseille, France, 13385
Montpellier, France, 34295
Nice, France, 06202
Paris, France, 75571
Paris, France, 75651
Pessac, France, 33604
Rennes, France, 35033
Rouen, France, 76031
Saint Laurent Du Var, France, 06721
Strasbourg, France, 67091
Toulouse, France, 31059
Tourcoing, France, 59208
Vandoeuvre-les-nancy, France, 54511
Villejuif, France, 94804
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00560274     History of Changes
Other Study ID Numbers: ML21362
First Posted: November 19, 2007    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Hematologic Diseases
Epoetin Alfa
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents