Clinical trial NCT01585324: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-04-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Sustained Virological Response (SVR) 24 Weeks After End of Treatment
timeFrame: 24 weeks after the end of treatment (72 weeks)
measure: Change From Baseline in Hemoglobin Level at Week 12 of Treatment Among Participants With or Without SVR
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Number of Participants With Decrease in Hemoglobin
timeFrame: Week 12
measure: Lowest Hemoglobin Level During Treatment Among Participants With or Without SVR
timeFrame: Week 12
measure: Number of Participants With Reduction in Ribavirin Dose Due to Drop in Hemoglobin Among Participants With or Without SVR
timeFrame: Week 12
measure: Number of Participants With Neutropenia Among Participants With or Without SVR
timeFrame: Week 12
measure: Number of Participants With Thrombocytopenia Among Participants With or Without SVR
timeFrame: Week 12
Other outcomes:
Locations:
city: Most
country: Czech Republic
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: