Back to resultsA Study of PEGASYS (Peginterferon Alfa-2a) Plus Ribavirin in Patients With Chronic Hepatitis C (CHC), Genotype 2 or 3
Primary Purpose
Hepatitis C, Chronic
Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
peginterferon alfa-2a [Pegasys]
peginterferon alfa-2a [Pegasys]
ribavirin
ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C, Chronic
Eligibility Criteria
Inclusion Criteria:
- Adult patients, 18-65 years of age
- Chronic hepatitis C, genotype 2 or 3
- Positive HCV RNA level in serum at screening (COBAS AMPLICOR MONITOR HCV test)
- Abdominal sonography within 3 months prior to study start
Exclusion Criteria:
- Previous interferon and/or pegylated interferon and ribavirin therapy
- Liver cirrhosis, class B or C (Child-Pugh)
- Systemic anti-neoplastic or immunomodulatory treatment <=6 months before study drug
- History or evidence of medical condition associated with chronic liver disease other than chronic hepatitis C
- Decompensated liver disease
- Positive for HIV
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Peginterferon/Ribavirin 800 mg (24 Weeks)
Peginterferon/Ribavirin 400 mg (24 Weeks)
Peginterferon/Ribavirin 800 mg (16 Weeks)
Peginterferon/Ribavirin 400 mg (16 Weeks)
Arm Description
Participants received peginterferon alfa-2a (PEG-IFNα-2a) 180 mcg once weekly + Ribavirin 800 mg daily for 24 weeks (W).
Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 400 mg daily for 24 W.
Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 800 mg daily for 16 W.
Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 400 mg daily for 16 W.
Outcomes
Primary Outcome Measures
Percentage of Participants Who Achieve Sustained Virologic Response Rate At 24 Weeks Post Completion of the Treatment
Sustained virological response was defined as the percentage of participants in each group with undetectable Hepatitis C virus-Ribonucleic acid (HCV-RNA) measurement at 24 weeks post completion of the treatment.
Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48
Serum Hepatitis C Virus-RNA (HCV-RNA) was done by Polymerase chain reaction (PCR). Samples for a qualitative PCR (AMPLICOR® HCV Test v2.0) were obtained at Week 24 and Week 48. 'G2' and 'G3' indicates Genotype 2 and Genotype 3 respectively.
Secondary Outcome Measures
Percentage of Participants With Virological Response at the End of the Treatment
Virological response at the end of the treatment (ETR) was defined as the percentage of participants with negative qualitative PCR in each group at completion of the treatment. ETR is defined as Week 16 and Week 24.
Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment
Virologic Response was defined as undetectable HCV-RNA levels (determined by AMPLICOR HCV test) at Week 16 and Week 24. Virologic response rates based on genotype (G2 and G3) were reported. ETR is defined as Week 16 and Week 24.
Number of Participants With Any Adverse Events and Any Serious Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Median Hemoglobin Levels at End of Treatment
Hemoglobin (Hb) levels at end of treatment (Week 16 and Week 24) were reported. The mean lowest Hb value after treatment starts with a median of 129 gram (g)/Litre (L). The far most frequent hemoglobin class was >=100 g/L. The purpose of assessing the Hb levels is associated with ribavirin dose. The primary toxicity of ribavirin dose (1000-1200 mg/day, maximum tolerated dose) is anemia with a reduction in hemoglobin levels generally occurring within the first 1-2 weeks of initiating therapy. Decreases in hemoglobin seen in the combination treatment of ribavirin and Interferon-alfa are managed with reduction in ribavirin dosage to 600 mg/day.
Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48
Short-Form Health Survey (SF-36) is a 36-item questionnaire measuring eight domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Where Baseline (BS) is Week 0.
Mean FSS Scores at Baseline and Weeks 16, 24 and 48
The Fatigue Severity Scale (FSS) is a self-administered instrument that includes 9 items rated on a 7-point scale, measuring fatigue severity. The participants were asked to score each statement, based on how the statement applied to them over the preceding week. The fatigue severity score is the average of the scores on the 9 questions; scores range from 1-7, with lower scores indicating less fatigue. Baseline is defined as Week 0.
Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48
Psychiatric assessment were performed using Beschwerdeliste (BL) questionnaires. BL results were analyzed descriptively by visit, treatment group, genotype and opioid maintenance therapy status. The BL questionnaire items were scored by calculating the average response to all answered items. Items were graded 1="stark" (affliction is strong) to 4="gar nicht" (not present). The higher the BL score, the less afflictions were present for a participant. Baseline is defined as Week 0.
Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48
For the psychiatric assessment, the results of the Beck Depression Inventory (BDI) questionnaires were evaluated. BDI results were analyzed descriptively by visit, treatment group, genotype and opioid maintenance therapy status. BDI is 21 item participant rated inventory evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. Total score: 0 to 63; higher score indicates more depression. Mean scores are presented by visit. Baseline is defined as Week 0.
Time to Viral Response
Time to viral response was calculated as Date of first negative PCR result after screening - date of PCR screening sample + 1 [in days]. Mean of number of days to viral response for overall population were reported.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01258101
Brief Title
A Study of PEGASYS (Peginterferon Alfa-2a) Plus Ribavirin in Patients With Chronic Hepatitis C (CHC), Genotype 2 or 3
Official Title
Randomized, Multicenter Study to Compare the Efficacy of Pegylated Interferon Alfa (PEG-IFN) in Combination With Two Different Doses of Ribavirin in Patients With Chronic Hepatitis C and Subtype 2/3
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (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 randomized, parallel arm study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with chronic hepatitis C, genotype 2 or 3. Patients will be randomized to 4 treatment groups receiving Pegasys (180 mcg subcutaneously weekly) for either 16 or 24 weeks with one of two doses of ribavirin (400 mg or 800 mg orally daily). The anticipated time on study treatment is 16 or 24 weeks with a 24-week follow-up.
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
395 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peginterferon/Ribavirin 800 mg (24 Weeks)
Arm Type
Experimental
Arm Description
Participants received peginterferon alfa-2a (PEG-IFNα-2a) 180 mcg once weekly + Ribavirin 800 mg daily for 24 weeks (W).
Arm Title
Peginterferon/Ribavirin 400 mg (24 Weeks)
Arm Type
Experimental
Arm Description
Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 400 mg daily for 24 W.
Arm Title
Peginterferon/Ribavirin 800 mg (16 Weeks)
Arm Type
Experimental
Arm Description
Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 800 mg daily for 16 W.
Arm Title
Peginterferon/Ribavirin 400 mg (16 Weeks)
Arm Type
Experimental
Arm Description
Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 400 mg daily for 16 W.
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
180 mcg sc weekly, 24 weeks
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
180 mcg sc weekly, 16 weeks
Intervention Type
Drug
Intervention Name(s)
ribavirin
Intervention Description
800 mg orally daily
Intervention Type
Drug
Intervention Name(s)
ribavirin
Intervention Description
400 mg orally daily
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieve Sustained Virologic Response Rate At 24 Weeks Post Completion of the Treatment
Description
Sustained virological response was defined as the percentage of participants in each group with undetectable Hepatitis C virus-Ribonucleic acid (HCV-RNA) measurement at 24 weeks post completion of the treatment.
Time Frame
Up to Week 48 (24 weeks post completion of the treatment)
Title
Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48
Description
Serum Hepatitis C Virus-RNA (HCV-RNA) was done by Polymerase chain reaction (PCR). Samples for a qualitative PCR (AMPLICOR® HCV Test v2.0) were obtained at Week 24 and Week 48. 'G2' and 'G3' indicates Genotype 2 and Genotype 3 respectively.
Time Frame
At Week 24 and Week 48
Secondary Outcome Measure Information:
Title
Percentage of Participants With Virological Response at the End of the Treatment
Description
Virological response at the end of the treatment (ETR) was defined as the percentage of participants with negative qualitative PCR in each group at completion of the treatment. ETR is defined as Week 16 and Week 24.
Time Frame
At Week 16 and Week 24
Title
Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment
Description
Virologic Response was defined as undetectable HCV-RNA levels (determined by AMPLICOR HCV test) at Week 16 and Week 24. Virologic response rates based on genotype (G2 and G3) were reported. ETR is defined as Week 16 and Week 24.
Time Frame
At Week 16 and Week 24
Title
Number of Participants With Any Adverse Events and Any Serious Adverse Events
Description
An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Time Frame
Up to Week 48
Title
Median Hemoglobin Levels at End of Treatment
Description
Hemoglobin (Hb) levels at end of treatment (Week 16 and Week 24) were reported. The mean lowest Hb value after treatment starts with a median of 129 gram (g)/Litre (L). The far most frequent hemoglobin class was >=100 g/L. The purpose of assessing the Hb levels is associated with ribavirin dose. The primary toxicity of ribavirin dose (1000-1200 mg/day, maximum tolerated dose) is anemia with a reduction in hemoglobin levels generally occurring within the first 1-2 weeks of initiating therapy. Decreases in hemoglobin seen in the combination treatment of ribavirin and Interferon-alfa are managed with reduction in ribavirin dosage to 600 mg/day.
Time Frame
At Week 16 and Week 24
Title
Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48
Description
Short-Form Health Survey (SF-36) is a 36-item questionnaire measuring eight domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Where Baseline (BS) is Week 0.
Time Frame
At Baseline (Week 0) and Weeks 16, 24 and 48
Title
Mean FSS Scores at Baseline and Weeks 16, 24 and 48
Description
The Fatigue Severity Scale (FSS) is a self-administered instrument that includes 9 items rated on a 7-point scale, measuring fatigue severity. The participants were asked to score each statement, based on how the statement applied to them over the preceding week. The fatigue severity score is the average of the scores on the 9 questions; scores range from 1-7, with lower scores indicating less fatigue. Baseline is defined as Week 0.
Time Frame
At Baseline (Week 0) and Weeks 16, 24 and 48
Title
Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48
Description
Psychiatric assessment were performed using Beschwerdeliste (BL) questionnaires. BL results were analyzed descriptively by visit, treatment group, genotype and opioid maintenance therapy status. The BL questionnaire items were scored by calculating the average response to all answered items. Items were graded 1="stark" (affliction is strong) to 4="gar nicht" (not present). The higher the BL score, the less afflictions were present for a participant. Baseline is defined as Week 0.
Time Frame
At Baseline (Week 0) and Weeks 16, 24 and 48
Title
Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48
Description
For the psychiatric assessment, the results of the Beck Depression Inventory (BDI) questionnaires were evaluated. BDI results were analyzed descriptively by visit, treatment group, genotype and opioid maintenance therapy status. BDI is 21 item participant rated inventory evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. Total score: 0 to 63; higher score indicates more depression. Mean scores are presented by visit. Baseline is defined as Week 0.
Time Frame
At Baseline (Week 0) and Weeks 4, 8, 12, 24 and 48
Title
Time to Viral Response
Description
Time to viral response was calculated as Date of first negative PCR result after screening - date of PCR screening sample + 1 [in days]. Mean of number of days to viral response for overall population were reported.
Time Frame
Up to Week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients, 18-65 years of age
Chronic hepatitis C, genotype 2 or 3
Positive HCV RNA level in serum at screening (COBAS AMPLICOR MONITOR HCV test)
Abdominal sonography within 3 months prior to study start
Exclusion Criteria:
Previous interferon and/or pegylated interferon and ribavirin therapy
Liver cirrhosis, class B or C (Child-Pugh)
Systemic anti-neoplastic or immunomodulatory treatment <=6 months before study drug
History or evidence of medical condition associated with chronic liver disease other than chronic hepatitis C
Decompensated liver disease
Positive for HIV
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Gratwein
ZIP/Postal Code
8112
Country
Austria
City
Graz
ZIP/Postal Code
8036
Country
Austria
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
City
Linz
ZIP/Postal Code
4010
Country
Austria
City
Linz
ZIP/Postal Code
4020
Country
Austria
City
Oberndorf
ZIP/Postal Code
5110
Country
Austria
City
Ried-innkreis
ZIP/Postal Code
4910
Country
Austria
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
City
Villach
ZIP/Postal Code
9500
Country
Austria
City
Wels
ZIP/Postal Code
4600
Country
Austria
City
Wiener Neustadt
ZIP/Postal Code
2700
Country
Austria
City
Wien
ZIP/Postal Code
1030
Country
Austria
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Wien
ZIP/Postal Code
1100
Country
Austria
City
Wien
ZIP/Postal Code
1130
Country
Austria
City
Wien
ZIP/Postal Code
1140
Country
Austria
City
Wien
ZIP/Postal Code
1160
Country
Austria
City
Wien
ZIP/Postal Code
1220
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
21714878
Citation
Maieron A, Metz-Gercek S, Scherzer TM, Laferl H, Fischer G, Bischof M, Gschwantler M, Ferenci P. Shortening of treatment duration in patients with chronic hepatitis C genotype 2 and 3 - impact of ribavirin dose - a randomized multicentre trial. BMC Res Notes. 2011 Jun 29;4:220. doi: 10.1186/1756-0500-4-220.
Results Reference
derived
Learn more about this trial
A Study of PEGASYS (Peginterferon Alfa-2a) Plus Ribavirin in Patients With Chronic Hepatitis C (CHC), Genotype 2 or 3
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