Trial Outcomes & Findings for A Quality of Life Study of Peginterferon-Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C and Persistently Normal Alanine Transaminase (ALT) Levels (NCT NCT02726022)
NCT ID: NCT02726022
Last Updated: 2016-08-15
Results Overview
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).
COMPLETED
114 participants
Baseline, EOT (up to 48 weeks)
2016-08-15
Participant Flow
Participant milestones
| Measure |
Chronic Hepatitis C Participants
Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a (Pegasys) and ribavirin (Copegus) for four weeks, were observed up to 24 weeks after end of treatment (EOT) (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
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|---|---|
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Overall Study
STARTED
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114
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Overall Study
COMPLETED
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78
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Overall Study
NOT COMPLETED
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36
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Reasons for withdrawal
| Measure |
Chronic Hepatitis C Participants
Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a (Pegasys) and ribavirin (Copegus) for four weeks, were observed up to 24 weeks after end of treatment (EOT) (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
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Overall Study
Adverse Event
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14
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Overall Study
Treatment Failure
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8
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Overall Study
Poor Compliance
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13
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Overall Study
Treatment Failure and Poor Compliance
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1
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Baseline Characteristics
A Quality of Life Study of Peginterferon-Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C and Persistently Normal Alanine Transaminase (ALT) Levels
Baseline characteristics by cohort
| Measure |
Chronic Hepatitis C Participants
n=114 Participants
Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
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Age, Continuous
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46.30 years
STANDARD_DEVIATION 13.31 • n=5 Participants
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Sex: Female, Male
Female
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55 Participants
n=5 Participants
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Sex: Female, Male
Male
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59 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline, EOT (up to 48 weeks)Population: Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 76; participants evaluable for Drug Addiction = 75. Same participants could be evaluated under Gender and Drug Addiction.
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).
Outcome measures
| Measure |
Chronic Hepatitis C Participants
n=76 Participants
Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
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|---|---|
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Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT)
Gender: Male
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-3.2 units on a scale
Standard Deviation 24.6
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Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT)
Gender: Female
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-3.0 units on a scale
Standard Deviation 29.2
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Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT)
Drug Addiction: Yes
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-7.4 units on a scale
Standard Deviation 26.5
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Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT)
Drug Addiction: No
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-1.2 units on a scale
Standard Deviation 27.1
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PRIMARY outcome
Timeframe: Baseline, 24 weeks after EOT (up to 72 weeks)Population: Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 56; participants evaluable for Drug Addiction = 56. Same participants could be evaluated under Gender and Drug Addiction.
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).
Outcome measures
| Measure |
Chronic Hepatitis C Participants
n=56 Participants
Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
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|---|---|
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Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT
Gender: Male
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0.3 units on a scale
Standard Deviation 26.3
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Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT
Gender: Female
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15.4 units on a scale
Standard Deviation 25.0
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Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT
Drug Addiction: Yes
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8.4 units on a scale
Standard Deviation 18.7
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Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT
Drug Addiction: No
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7.6 units on a scale
Standard Deviation 29.1
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PRIMARY outcome
Timeframe: Baseline, EOT (up to 48 weeks)Population: Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 76; participants evaluable for Drug Addiction = 75. Same participants could be evaluated under Gender and Drug Addiction.
SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).
Outcome measures
| Measure |
Chronic Hepatitis C Participants
n=76 Participants
Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
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|---|---|
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Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT
Gender: Male
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-0.7 units on a scale
Standard Deviation 24.6
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Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT
Gender: Female
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0.17 units on a scale
Standard Deviation 26.5
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Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT
Drug Addiction: Yes
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-0.4 units on a scale
Standard Deviation 18.7
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Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT
Drug Addiction: No
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-0.1 units on a scale
Standard Deviation 27.7
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PRIMARY outcome
Timeframe: Baseline, 24 weeks after EOT (up to 72 weeks)Population: Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 56; participants evaluable for Drug Addiction = 56. Same participants could be evaluated under Gender and Drug Addiction.
SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).
Outcome measures
| Measure |
Chronic Hepatitis C Participants
n=56 Participants
Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
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|---|---|
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Change From Baseline in SF-36 PCS at 24 Weeks After EOT
Gender: Male
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0.1 units on a scale
Standard Deviation 27.5
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Change From Baseline in SF-36 PCS at 24 Weeks After EOT
Gender: Female
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15.8 units on a scale
Standard Deviation 23.8
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Change From Baseline in SF-36 PCS at 24 Weeks After EOT
Drug Addiction: Yes
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6.7 units on a scale
Standard Deviation 17.1
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Change From Baseline in SF-36 PCS at 24 Weeks After EOT
Drug Addiction: No
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8.4 units on a scale
Standard Deviation 29.6
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PRIMARY outcome
Timeframe: Baseline, EOT (up to 48 weeks)Population: Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 76; participants evaluable for Drug Addiction = 75. Same participants could be evaluated under Gender and Drug Addiction.
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning).
Outcome measures
| Measure |
Chronic Hepatitis C Participants
n=76 Participants
Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
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|---|---|
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Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT
Gender: Male
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-5.10 units on a scale
Standard Deviation 25.9
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Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT
Gender: Female
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-3.47 units on a scale
Standard Deviation 25.3
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Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT
Drug Addiction: Yes
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-9.4 units on a scale
Standard Deviation 23.3
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Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT
Drug Addiction: No
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-2.1 units on a scale
Standard Deviation 26.2
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PRIMARY outcome
Timeframe: Baseline, 24 weeks after EOT (up to 72 weeks)Population: Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 56; participants evaluable for Drug Addiction = 56. Same participants could be evaluated under Gender and Drug Addiction.
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning).
Outcome measures
| Measure |
Chronic Hepatitis C Participants
n=56 Participants
Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
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|---|---|
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Change From Baseline in SF-36 MCS at 24 Weeks After EOT
Gender: Male
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-3.2 units on a scale
Standard Deviation 27.1
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Change From Baseline in SF-36 MCS at 24 Weeks After EOT
Gender: Female
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6.5 units on a scale
Standard Deviation 30.7
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Change From Baseline in SF-36 MCS at 24 Weeks After EOT
Drug Addiction: Yes
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4.4 units on a scale
Standard Deviation 26.4
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Change From Baseline in SF-36 MCS at 24 Weeks After EOT
Drug Addiction: No
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0.9 units on a scale
Standard Deviation 30.6
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Adverse Events
Chronic Hepatitis C Participants
Serious adverse events
| Measure |
Chronic Hepatitis C Participants
n=114 participants at risk
Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
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Cardiac disorders
Hypertensive Crisis
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0.88%
1/114 • Baseline up to Week 72
Due to observational nature of the study only serious adverse events and peginterferon-alfa 2a-related non-serious adverse event were collected.
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Other adverse events
| Measure |
Chronic Hepatitis C Participants
n=114 participants at risk
Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
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Blood and lymphatic system disorders
Anemia
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11.4%
13/114 • Baseline up to Week 72
Due to observational nature of the study only serious adverse events and peginterferon-alfa 2a-related non-serious adverse event were collected.
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Blood and lymphatic system disorders
Leucopenia
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12.3%
14/114 • Baseline up to Week 72
Due to observational nature of the study only serious adverse events and peginterferon-alfa 2a-related non-serious adverse event were collected.
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Blood and lymphatic system disorders
Thrombocytopenia
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5.3%
6/114 • Baseline up to Week 72
Due to observational nature of the study only serious adverse events and peginterferon-alfa 2a-related non-serious adverse event were collected.
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General disorders
Fatigue
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7.0%
8/114 • Baseline up to Week 72
Due to observational nature of the study only serious adverse events and peginterferon-alfa 2a-related non-serious adverse event were collected.
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General disorders
Fever
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5.3%
6/114 • Baseline up to Week 72
Due to observational nature of the study only serious adverse events and peginterferon-alfa 2a-related non-serious adverse event were collected.
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General disorders
Headache
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5.3%
6/114 • Baseline up to Week 72
Due to observational nature of the study only serious adverse events and peginterferon-alfa 2a-related non-serious adverse event were collected.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER