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)

Roche

Status and phase: Completed; Phase 4

Conditions: Hepatitis C, Chronic

Treatments: Drug: ribavirin [Copegus]; Drug: peginterferon alfa-2a [Pegasys]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01585324

2011-001256-10 (EudraCT Number)

ML25186

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Single Arm

Experimental group

Treatment:

Drug: ribavirin [Copegus]

Drug: peginterferon alfa-2a [Pegasys]