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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: November 16, 2007
Last updated: February 1, 2016
Last verified: February 2016
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
Drug: Pegasys
Drug: Ribavirin
Drug: epoetin beta [NeoRecormon]
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

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

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

Enrollment: 190
Study Start Date: March 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Pegasys
As prescribed
Drug: Ribavirin
As prescribed
Drug: epoetin beta [NeoRecormon]
30,000 IU sc/week (starting dose)


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT00560274     History of Changes
Other Study ID Numbers: ML21362
Study First Received: November 16, 2007
Last Updated: February 1, 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
Hematinics processed this record on March 28, 2017