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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00560274
First received: November 16, 2007
Last updated: October 20, 2014
Last verified: October 2014
  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 Pegylate d 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 maint ain 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: Pegasys
Drug: Ribavirin
Drug: epoetin beta [NeoRecormon]
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ 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 ]

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)

  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
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 ClinicalTrials.gov identifier: NCT00560274

Locations
France
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
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00560274     History of Changes
Other Study ID Numbers: ML21362
Study First Received: November 16, 2007
Last Updated: October 20, 2014
Health Authority: France:Agence francaise de securite sanitaire des produits de sante (AFSSAPS)

Additional relevant MeSH terms:
Anemia
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Flaviviridae Infections
Hematologic Diseases
Hepatitis
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014