Trial Information

Summary: A Study of Mircera in Patients With Non-Hodgkin's Lymphoma and Anemia.

Status: Completed

Protocol Number: BA16728

Sponsor: Hoffmann-La Roche Inc

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of subcutaneous Mircera on hemoglobin level/correction in patients with anemia and aggressive or indolent B-cell non-Hodgkin's lymphoma

Brief Summary: This study will evaluate the efficacy and safety of different subcutaneous doses of Mircera to treat anemia in patients with non-Hodgkin's lymphoma (NHL) who are receiving combination chemotherapy. The anticipated time on study treatment is < 3 months and the target sample size is <100 individuals. Target sample size is 93.

Study Phase: II

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Anemia

Intervention Type: Drug

Intervention Name: methoxy polyethylene glycol-epoetin beta[Mircera]

Primary Outcome: 1. Efficacy: Time-adjusted average hemoglobin value between baseline and end of initial treatment

Key Secondary Outcomes: 1. Efficacy: Change in Hb, Hct, and reticulocyte count; Hb and hematopoietic response Safety: Vital signs, AEs, laboratory values

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 05/23/2005

Date Last Updated: 10/17/2008

Link To Trial Results

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Trial listings updated: November 17, 2008 at 2:31:35 PM