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)
- Conditions
- Hepatitis C, Chronic
- Interventions
- Drug: peginterferon alfa-2a [Pegasys]Drug: ribavirin [Copegus]
- Registration Number
- NCT01585324
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm peginterferon alfa-2a [Pegasys] - Single Arm ribavirin [Copegus] -
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin Level at Week 12 of Treatment Among Participants With or Without SVR 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.
Percentage of Participants With Sustained Virological Response (SVR) 24 Weeks After End of Treatment 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Decrease in Hemoglobin 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.
Lowest Hemoglobin Level During Treatment Among Participants With or Without SVR 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.
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