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)
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)
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 24, 2012
CompletedFirst Posted
Study publicly available on registry
April 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedResults Posted
Study results publicly available
July 24, 2015
CompletedJuly 24, 2015
June 1, 2015
2 years
April 24, 2012
June 25, 2015
June 25, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
Number of Participants With Decrease in Hemoglobin
Week 12
Lowest Hemoglobin Level During Treatment Among Participants With or 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
Study Arms (1)
Single Arm
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Most, 43401, Czechia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2012
First Posted
April 25, 2012
Study Start
January 1, 2012
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
July 24, 2015
Results First Posted
July 24, 2015
Record last verified: 2015-06