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OpenTrials
Completed

NCT Number: NCT00560274

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

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pegasys

Drug

As prescribed

Ribavirin

Drug

As prescribed

epoetin beta [NeoRecormon]

Drug

30,000 IU sc/week (starting dose)

Primary outcomes

  1. Blood pressure, pulse rate.

    Time frame: 6 and 12 months

  2. AEs, and laboratory parameters.

    Time frame: Throughout study

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 19, 2007
Registry last updated
Feb 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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