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

Hoffmann-La Roche190 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

190

Conditions

Anemia

Interventions

PegasysDRUG

As prescribed

RibavirinDRUG

As prescribed

epoetin beta [NeoRecormon]DRUG

30,000 IU sc/week (starting dose)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (24)

Unnamed facility

Angers, France

Unnamed facility

Besançon, France

Unnamed facility

Outcomes

Primary Outcomes

Blood pressure, pulse rate.

Time frame: 6 and 12 months

AEs, and laboratory parameters.

Time frame: Throughout study

Secondary Outcomes

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

Data from ClinicalTrials.gov

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