Trial information
A Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Chronic Hepatitis C.
Status: Recruiting
Protocol number: ML21362
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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
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. Target sample size is
200.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: epoetin beta [NeoRecormon]
Primary outcome: 1. Blood pressure, pulse rate. Time frame: 6 and 12 months
2. AEs, and laboratory parameters. Time frame: Throughout study
Key secondary outcomes: 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
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: March, 2008
Trial registration date: 11/16/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
France
- Angers
- Besancon
- Caen
- Chambray-Lès-Tours
- Clichy
- Creteil
- Limoges
- Lyon
- Marseille
- Montpellier
- Nice
- Paris
- Pessac
- Rennes
- Rouen
- Saint Laurent Du Var
- Strasbourg
- Toulouse
- Tourcoing
- Vandoeuvre-Les-Nancy
- Villejuif
