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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560274
• Other study ID #: ML21362
• Status: Completed
• Phase: Phase 4
• First received: November 16, 2007
• Last updated: February 1, 2016
• Start date: March 2008
• Est. completion date: November 2011

Study information

• Verified date: February 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France:Agence francaise de securite sanitaire des produits de sante (AFSSAPS)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Pegasys
As prescribed
• Ribavirin
As prescribed
• epoetin beta [NeoRecormon]
30,000 IU sc/week (starting dose)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure, pulse rate.		6 and 12 months	Yes
Primary	AEs, and laboratory parameters.		Throughout study	No
Secondary	Percentage of patients achieving correction of anemia		3 months	No
Secondary	Percentage of patients not requiring blood transfusion		12 months	No
Secondary	Course of Hb concentration		12 months	No
Secondary	Percentage of patients maintaining initial ribavirin dose		12 months	No