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)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: peginterferon alfa-2a [Pegasys]
* Drug: ribavirin [Copegus]


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Sustained Virological Response (SVR) 24 Weeks After End of Treatment | 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 | 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 | 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 | 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 |  | Week 12 | 
| Number of Participants With Neutropenia Among Participants With or Without SVR |  | Week 12 | 
| Number of Participants With Thrombocytopenia Among Participants With or Without SVR |  | Week 12 |