Back to resultsA 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)
Primary Purpose
Hepatitis C, Chronic
Status
Completed
Phase
Phase 4
Locations
Czech Republic
Study Type
Interventional
Intervention
peginterferon alfa-2a [Pegasys]
ribavirin [Copegus]
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C, Chronic
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Number of Participants With Reduction in Ribavirin Dose Due to Drop in Hemoglobin Among Participants With or Without SVR
Number of Participants With Neutropenia Among Participants With or Without SVR
Number of Participants With Thrombocytopenia Among Participants With or Without SVR
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01585324
Brief Title
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
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
180 mcg subcutaneously weekly
Intervention Type
Drug
Intervention Name(s)
ribavirin [Copegus]
Intervention Description
1000 mg or 1200 mg orally daily
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virological Response (SVR) 24 Weeks After End of Treatment
Description
SVR was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
Time Frame
24 weeks after the end of treatment (72 weeks)
Title
Change From Baseline in Hemoglobin Level at Week 12 of Treatment Among Participants With or Without SVR
Description
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.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Number of Participants With Decrease in Hemoglobin
Description
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.
Time Frame
Week 12
Title
Lowest Hemoglobin Level During Treatment Among Participants With or Without SVR
Description
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.
Time Frame
Week 12
Title
Number of Participants With Reduction in Ribavirin Dose Due to Drop in Hemoglobin Among Participants With or Without SVR
Time Frame
Week 12
Title
Number of Participants With Neutropenia Among Participants With or Without SVR
Time Frame
Week 12
Title
Number of Participants With Thrombocytopenia Among Participants With or Without SVR
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Most
ZIP/Postal Code
43401
Country
Czech Republic
12. IPD Sharing Statement
Learn more about this trial
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)
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