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| ID | Type | Description | Link |
|---|---|---|---|
| MK-4031-336 | Other Identifier | Merck |
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The primary objective of this study is to evaluate the impact of chronic hepatitis C (CHC), and the treatment thereof with peginterferon alpha-2b (PEG) and ribavirin (RBV) according to standard clinical practice, on the health-related quality of life (HRQL) of a cohort of participants throughout 72 weeks of follow-up. HRQL was assessed using the 36-Item Short-Form Health Survey (SF-36) and the Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV).
As widely shown in previous reports Hepatitis C Virus (HCV) patients commonly experience fatigue, anxiety, and depression. These symptoms negatively affect patients' functional health, ability to work, self-perceived health, HRQL and well-being. Psychosocial issues and reduced HRQL are frequently experienced by HCV patients. HCV patients have more HRQL impairment than the general population. There is some evidence that HCV patients who experience greater fatigue, greater psychiatric symptoms, and poorer HRQL are more likely to discontinue treatment prematurely, with a negative impact on virological response. In addition to well-known side effects of interferon, one important determinant of HRQL during anti-viral therapy for HCV is development of RBV-induced anemia. Treatment of anemia improves HRQL, potentially impacting adherence to antiviral regimen and improving virologic response. These issues emphasize the importance of investigating the physical and psychosocial experiences and HRQL of HCV patients.
The sample size of the study must allow evaluating HRQL of HCV patients based on the SF-36 before PEG treatment and at each of the following study visits.
To be able to detect differences of or over 4.2 points in the vitality dimension between the basal visit and following visits, estimating a standard deviation of 22 points, a statistical power of 80%, and a level of significance of 0.05, 216 patients will be needed. Considering a loss of follow up of 15%, a total of 238 patients are planned for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG + RBV (Standard Clinical Practice) | Participants receive peginterferon alfa-2b (PEG) and ribavirin (RBV) in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2b (PEG) | Biological | Pegylated interferon alfa-2b was administered in accordance with the dosage and pattern prescribed by each participant's physician (standard clinical practice). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status. | Baseline, Week 72 |
| Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV) | The CLDQ-HCV is a disease-specific questionnaire measuring HRQL that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency ("all of the time") and 7 to the minimum ("none of the time"). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life. | Baseline, Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status. |
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Inclusion Criteria:
Exclusion Criteria:
- Participants co-infected with Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV)
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Participants with Chronic Hepatitis C, Genotype 1, no other co-infection and compensated liver disease who receive PEG and RBV in combination therapy according to standard clinical practice.
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
Of 133 participants who enrolled on study, 3 participants failed screening and 130 were evaluable for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | PEG + RBV (Standard Clinical Practice) | Participants receive peginterferon alfa-2b (PEG) and ribavirin (RBV) in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period |
| |||||||||||||
| Follow-up Period |
|
Of 133 enrolled participants, Baseline Characteristics were reported for 130 evaluable participants. 3 enrolled participants who failed screening did not have Baseline Characteristics reported.
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| ID | Title | Description |
|---|---|---|
| BG000 | PEG + RBV (Standard Clinical Practice) | Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status. | All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had SF-36 data available at baseline and Week 72. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 72 |
From Baseline visit to Final Visit (up to 72 weeks)
Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PEG + RBV (Standard Clinical Practice) | Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C417083 | peginterferon alfa-2b |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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|
| Ribavirin (RBV) | Drug | Ribavirin was administered in accordance with the dosage and pattern prescribed by each participant's physician (standard clinical practice). |
|
|
| Baseline, Week 72 |
| Change From Baseline to Week 72 (WK72) in CLDQ-HCV Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | The CLDQ-HCV is a disease-specific questionnaire measuring quality of life that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency ("all of the time") and 7 to the minimum ("none of the time"). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life. | Baseline, Week 72 |
| Minimal Clinically Important Difference (MCID) in SF-36 Scores | SF-36 is a 36-item questionnaire measuring HRQL covering 2 summary measures, PCS and MCS. The SF-36 consists of 8 subscales. PCS is represented by physical function, role limitations-physical, pain, and general health perception. MCS is represented by vitality, social function, role limitations-emotional, and mental health. Subscale items are summed and scaled from 0-100 to give subscale scores; 0= worst HRQL, 100=best HRQL. PCS and MCS summary scores are constructed as T-scores (mean =50, standard deviation=10) with no minimum or maximum score; higher scores indicate better health status. MCID was defined as the difference in questionnaire scores between baseline and final visits for those participants who had stated that their health status had changed at the end of the study (improved in one category of health status as perceived by themselves). The MCID was calculated for each subscale of the SF-36 and for PCS and MCS. | From Baseline Visit to Final Visit (up to 72 weeks) |
| MCID in CLDQ-HCV Scores | The CLDQ-HCV is a disease-specific questionnaire measuring HRQL that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency ("all of the time") and 7 to the minimum ("none of the time"). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life. MCID was defined as the difference in questionnaire scores between baseline and final visits for those participants who had stated that their health status had changed at the end of the study (improved in one category of health status perceived by themselves). The MCID was calculated for each domain of the CLDQ-HCV and for the CLDQ-HCV summary score. | From Baseline Visit to Final Visit (up to 72 weeks) |
| Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis) | Compliance was calculated as the amount of dispensed medication minus the amount of medication returned by participants divided by amount of dispensed medication. | From Baseline Visit to Final Visit (up to 72 weeks) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | PEG + RBV (Standard Clinical Practice) | Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation. |
|
|
| Primary | Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV) | The CLDQ-HCV is a disease-specific questionnaire measuring HRQL that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency ("all of the time") and 7 to the minimum ("none of the time"). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life. | All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had CLDQ-HCV data available at baseline and Week 72. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 72 |
|
|
|
|
| Secondary | Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status. | All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had SF-36 data available at baseline and Week 72. Analysis Population included 38 participants who completed 48 weeks of treatment and 8 participants who did not complete 48 weeks of treatment (early end). | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 72 |
|
|
|
|
| Secondary | Change From Baseline to Week 72 (WK72) in CLDQ-HCV Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | The CLDQ-HCV is a disease-specific questionnaire measuring quality of life that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency ("all of the time") and 7 to the minimum ("none of the time"). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life. | All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had CLDQ-HCV data available at baseline and Week 72. Analysis Population included 38 participants who completed 48 weeks of treatment and 8 participants who did not complete 48 weeks of treatment (early end). | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 72 |
|
|
|
|
| Secondary | Minimal Clinically Important Difference (MCID) in SF-36 Scores | SF-36 is a 36-item questionnaire measuring HRQL covering 2 summary measures, PCS and MCS. The SF-36 consists of 8 subscales. PCS is represented by physical function, role limitations-physical, pain, and general health perception. MCS is represented by vitality, social function, role limitations-emotional, and mental health. Subscale items are summed and scaled from 0-100 to give subscale scores; 0= worst HRQL, 100=best HRQL. PCS and MCS summary scores are constructed as T-scores (mean =50, standard deviation=10) with no minimum or maximum score; higher scores indicate better health status. MCID was defined as the difference in questionnaire scores between baseline and final visits for those participants who had stated that their health status had changed at the end of the study (improved in one category of health status as perceived by themselves). The MCID was calculated for each subscale of the SF-36 and for PCS and MCS. | All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had improved in one category of health status as perceived by themselves. | Posted | Mean | Standard Deviation | score on a scale | From Baseline Visit to Final Visit (up to 72 weeks) |
|
|
|
| Secondary | MCID in CLDQ-HCV Scores | The CLDQ-HCV is a disease-specific questionnaire measuring HRQL that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency ("all of the time") and 7 to the minimum ("none of the time"). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life. MCID was defined as the difference in questionnaire scores between baseline and final visits for those participants who had stated that their health status had changed at the end of the study (improved in one category of health status perceived by themselves). The MCID was calculated for each domain of the CLDQ-HCV and for the CLDQ-HCV summary score. | All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had improved in one category of health status as perceived by themselves. | Posted | Mean | Standard Deviation | score on a scale | From Baseline Visit to Final Visit (up to 72 weeks) |
|
|
|
| Secondary | Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis) | Compliance was calculated as the amount of dispensed medication minus the amount of medication returned by participants divided by amount of dispensed medication. | All Evaluable Participants; participants who had met the evaluation and eligibility criteria and were included in the study. Analysis Population included 53 participants who completed 48 weeks of treatment and 77 participants who did not complete 48 weeks of treatment (early end). | Posted | Number | percentage of participants | From Baseline Visit to Final Visit (up to 72 weeks) |
|
|
|
| 12 |
| 130 |
| 116 |
| 130 |
| APLASIA PURE RED CELL | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| BONE MARROW FAILURE | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| LYMPHOCYTIC INFILTRATION | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| TINNITUS | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| HAEMOGLOBIN DECREASED | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| PLATELET COUNT DECREASED | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| ACUTE PSYCHOSIS | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| DEPRESSED MOOD | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| INJECTION SITE REACTION | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| EMOTIONAL DISORDER | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| MENTAL DISORDER | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
The study data/results may not be published or disseminated without prior consent from the study sponsor. All publications arising from the study will cite all the participating researchers.
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| Emotional Function-BL (n=125) |
|
| Emotional Function-WK72 (n=46) |
|
| Emotional Function Change from BL (n=46) |
|
| Worry-BL (n=125) |
|
| Worry-WK72 (n=46) |
|
| Worry Change from BL (n=46) |
|
| Systemic Symptoms-BL (n=125) |
|
| Systemic Symptoms-WK72 (n=46) |
|
| Systemic Symptoms Change from BL (n=46) |
|
| CLDQ-HCV Global -BL (n=125) |
|
| CLDQ-HCV Global-WK72 (n=46) |
|
| CLDQ-HCV Global Change from BL (n=46) |
|
| Pain (n=38, n=8) |
|
| General Health (n=38, n=8) |
|
| Vitality (n=37, n=8) |
|
| Social Function (n=38, n=8) |
|
| Emotional Role (n=37, n=8) |
|
| Mental Health (n=37, n=8) |
|
| PCS (n=37, n=8) |
|
| MCS (n=37, n=8) |
|
| Worry (n=38, n=8) |
|
| Systemic Symptoms (n=38, n=8) |
|
| CLDQ-HCV Global (n=38, n=8) |
|
| Student´s t-test for paired samples |
| 0.009 |
| Superiority or Other |
| Between-group comparison of change from baseline in CLDQ-HCV Global domain | Student´s t-test for paired samples | 0.022 | Superiority or Other |
| Title | Measurements |
|---|---|
|
| General Health |
|
| Vitality |
|
| Social Function |
|
| Emotional Role |
|
| Mental Health |
|
| PCS |
|
| MCS |
|
| Title | Measurements |
|---|---|
|
| Systemic Symptoms |
|
| CLDQ-HCV Global |
|
| PEG + RBV |
|