A Study of The Relationship Between Drop in Hemoglobin and Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Copegus (Ribavirin) and Pegasys (Peginterferon Alfa-2a)

June 25, 2015 updated by: Hoffmann-La Roche

Open, Multicenter Phase IV Study, Evaluating Drop of Hemoglobin in Association to the Rate of Sustained Virological Response in Chronic Hepatitis C Patients Treated With Ribavirin (Copegus®) in Combination With Standard Treatment (ANECO)

This open-label, multicenter, phase IV study will evaluate the relationship between the drop in hemoglobin levels and sustained virological response in patients with chronic hepatitis C genotype 1 treated with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a). Patients will receive Copegus 1000 mg or 1200 mg orally daily and Pegasys 180 mcg subcutaneously weekly. Anticipated time on study treatment, depending on virological response, will be 48 or 72 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Chronic hepatitis C, genotype 1
  • Treatment-naïve or patients who relapsed or failed to respond to previous combination therapy with interferon and ribavirin
  • Detectable HCV-RNA
  • Fertile males and females of child-bearing potential must agree to use two forms of contraception during treatment and for 6 months after treatment end

Exclusion Criteria:

  • Pregnant or breast-feeding women
  • Male partners of pregnant women
  • History or evidence of a medical condition associated with chronic liver disease other than HCV
  • Co-infection with active hepatitis A, hepatitis B and/or HIV virus
  • Hepatocellular carcinoma
  • History or evidence of oesophageal varices or other conditions consistent with decompensated liver disease
  • Anemia
  • Any patient with increased baseline risk for anemia (e.g. thalassemia, spherocyctosis, history of GI bleeding)
  • History or evidence of significant cardiovascular disease
  • Kidney disease
  • Severe retinopathy
  • History of severe psychiatric disease, especially depression
  • Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) </= 6 months prior to first dose of study drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm
Drug: peginterferon alfa-2a [Pegasys]
180 mcg subcutaneously weekly
Drug: ribavirin [Copegus]
1000 mg or 1200 mg orally daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virological Response (SVR) 24 Weeks After End of Treatment
Time Frame: 24 weeks after the end of treatment (72 weeks)
SVR was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
24 weeks after the end of treatment (72 weeks)
Change From Baseline in Hemoglobin Level at Week 12 of Treatment Among Participants With or Without SVR
Time Frame: Baseline and Week 12
Change in hemoglobin level from a baseline level was assessed in the group of participants who achieved SVR and in the group of participants without SVR.
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Decrease in Hemoglobin
Time Frame: Week 12
The drop in hemoglobin level at Week 12 compared to level at baseline was assessed and categorized in pre-defined categories (up to 20, 20-40, greater than [>] 40 g/L) for the group of participants who achieved SVR and in the group of participants without SVR.
Week 12
Lowest Hemoglobin Level During Treatment Among Participants With or Without SVR
Time Frame: Week 12
The mean minimum hemoglobin value achieved during the treatment was assessed in the group of participants who achieved SVR and in the group of participants without SVR.
Week 12
Number of Participants With Reduction in Ribavirin Dose Due to Drop in Hemoglobin Among Participants With or Without SVR
Time Frame: Week 12
Week 12
Number of Participants With Neutropenia Among Participants With or Without SVR
Time Frame: Week 12
Week 12
Number of Participants With Thrombocytopenia Among Participants With or Without SVR
Time Frame: Week 12
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

April 24, 2012

First Submitted That Met QC Criteria

April 24, 2012

First Posted (Estimate)

April 25, 2012

Study Record Updates

Last Update Posted (Estimate)

July 24, 2015

Last Update Submitted That Met QC Criteria

June 25, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML25186
  • 2011-001256-10 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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