Back to resultsA Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Chronic Hepatitis C.
Primary Purpose
Anemia
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Pegasys
Ribavirin
epoetin beta [NeoRecormon]
Sponsored by
About this trial
This is an interventional treatment trial for Anemia
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Blood pressure, pulse rate.
AEs, and laboratory parameters.
Secondary Outcome Measures
Percentage of patients achieving correction of anemia
Percentage of patients not requiring blood transfusion
Course of Hb concentration
Percentage of patients maintaining initial ribavirin dose
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00560274
Brief Title
A Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Chronic Hepatitis C.
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 Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pegasys
Intervention Description
As prescribed
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
As prescribed
Intervention Type
Drug
Intervention Name(s)
epoetin beta [NeoRecormon]
Intervention Description
30,000 IU sc/week (starting dose)
Primary Outcome Measure Information:
Title
Blood pressure, pulse rate.
Time Frame
6 and 12 months
Title
AEs, and laboratory parameters.
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
Percentage of patients achieving correction of anemia
Time Frame
3 months
Title
Percentage of patients not requiring blood transfusion
Time Frame
12 months
Title
Course of Hb concentration
Time Frame
12 months
Title
Percentage of patients maintaining initial ribavirin dose
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Angers
ZIP/Postal Code
49933
Country
France
City
Besancon
ZIP/Postal Code
25030
Country
France
City
Caen
ZIP/Postal Code
14033
Country
France
City
Chambray Les Tours
ZIP/Postal Code
37171
Country
France
City
Clichy
ZIP/Postal Code
92118
Country
France
City
Creteil
ZIP/Postal Code
94000
Country
France
City
Creteil
ZIP/Postal Code
94010
Country
France
City
Limoges
ZIP/Postal Code
87042
Country
France
City
Lyon
ZIP/Postal Code
69437
Country
France
City
Marseille
ZIP/Postal Code
13285
Country
France
City
Marseille
ZIP/Postal Code
13385
Country
France
City
Montpellier
ZIP/Postal Code
34295
Country
France
City
Nice
ZIP/Postal Code
06202
Country
France
City
Paris
ZIP/Postal Code
75571
Country
France
City
Paris
ZIP/Postal Code
75651
Country
France
City
Pessac
ZIP/Postal Code
33604
Country
France
City
Rennes
ZIP/Postal Code
35033
Country
France
City
Rouen
ZIP/Postal Code
76031
Country
France
City
Saint Laurent Du Var
ZIP/Postal Code
06721
Country
France
City
Strasbourg
ZIP/Postal Code
67091
Country
France
City
Toulouse
ZIP/Postal Code
31059
Country
France
City
Tourcoing
ZIP/Postal Code
59208
Country
France
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54511
Country
France
City
Villejuif
ZIP/Postal Code
94804
Country
France
12. IPD Sharing Statement
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A Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Chronic Hepatitis C.
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