A Study to Evaluate the Erythropoietic Response in Hepatitis C Virus (HCV) Patients Receiving Combination Ribavirin (RBV)/Interferon (IFN) Therapy or RBV/PEG IFN (NATURAL HISTORY-HCV)

Hepatitis C Clinical Trial

Official title:

A Study to Evaluate the Erythropoietic Response in Hepatitis C Virus (HCV) Patients Receiving Combination Ribavirin (RBV)/Interferon (IFN) Therapy or RBV/PEG IFN

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00328549
• Other study ID #: CR005116
• Status: Completed
• Phase: Phase 2
• First received: May 19, 2006
• Last updated: May 17, 2011
• Start date: October 2001
• Est. completion date: December 2002

Study information

• Verified date: April 2010
• Source: Ortho Biotech Products, L.P.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to describe the time course and extent of hemoglobin (Hb) changes and the erythropoietic response to PEG-IFN/RBV-induced anemia In HCV-infected subjects.

Description:

Patients receiving combination therapy for chronic hepatitis C virus (HCV) infection (standard or pegylated interferon alfa [PEG-IFN] in combination with ribavirin [RBV]) frequently develop moderate to severe anemia. In large, prospective, clinical trials of PEG-IFN alfa-2b and PEG-IFN alfa-2a, the reported mean decreases in hemoglobin (Hb) were 2.5 g/dL and 3.7 g/dL, respectively. Furthermore, in a retrospective study, 54% of standard interferon/RBV-treated patients had hemoglobin (Hb) decreases of at least 3 g/dL. It is important to understand the causes, natural history, and risk factors associated with HCV therapy-induced anemia, because such decreases in Hb can result in RBV dose reduction or discontinuation, which may adversely affect the likelihood of a virologic response. Erythropoietin is an endogenous hormone that acts in the bone marrow to increase the number of erythroid progenitor cells. Normally, a decrease in the Hb level is accompanied by an increase in the serum erythropoietin (sEPO) level, which will ultimately normalize the Hb level. The relationship between Hb and sEPO is less apparent in patients with chronic diseases such as cancer and human immunodeficiency virus (HIV) infection. It is not known whether HCV-infected patients receiving combination PEG-IFN/RBV therapy have a similarly diminished erythropoietic response to anemia.

One hundred HCV-infected patients who are receiving combination RBV/IFN or RBV/PEG-IFN therapy will be enrolled in this multicenter study. No study medication will be administered during this study. Weekly blood samples will be collected at specified times during the initial 8 weeks of RBV/IFN or RBV/PEG-IFN therapy. Assessment of laboratory tests, vital signs, incidence and severity of adverse experiences will be obtained.

The objective of this study is to document the pattern of hemoglobin changes and erythropoietic response (from baseline to final assessment, up to Week 8) in HCV-infected patients receiving combination therapy with RBV/IFN or RBV/PEG-IFN. N/A

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Signed Informed Consent

• HCV- infected patients confirmed by PCR or branched DNA (b-DNA)

• Scheduled to commence combination RBV/IFN or RBV/PEG-IFN therapy on Day 1

• Normal serum creatinine

• Life expectancy > 6 months

Exclusion Criteria:

• HIV-infected patients

• History of any primary hematologic disease

• Anemia attributable to factors such as iron or folate deficiency, pre-treatment

• hemolysis or gastrointestinal bleeding

• Has suspected or confirmed significant hepatic disease from an etiology other than

• HCV (e.g. alcohol, HBV, autoimmune disease etc)

• Current, active substance abuser

• Pregnant or breast feeding

• Women of childbearing potential not taking adequate birth control measures

• Exposure to Epoetin alfa within three (3) months prior to study enrollment or during study

• Transfusion within three (3) months prior to study entry

Study Design

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

Related Conditions & MeSH terms

• Anemia
• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• Pegylated Interferon and Ribavirin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ortho Biotech Products, L.P.

References & Publications (1)

Balan V, Schwartz D, Wu GY, Muir AJ, Ghalib R, Jackson J, Keeffe EB, Rossaro L, Burnett A, Goon BL, Bowers PJ, Leitz GJ; HCV Natural History Study Group. Erythropoietic response to anemia in chronic hepatitis C patients receiving combination pegylated int — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoints were change in Hb and sEPO from baseline to week 8 (or early withdrawal)
Secondary	Other endpoints measured were changes in reticulocytes, platelets, total bilirubin, and RBV dose from baseline to week 8.

External Links

•   A Study to Evaluate the Erythropoietic Response in HCV Patients Receiving Combination Ribavirin/Interferon Therapy or Ribavirin/PEG-Interferon