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This prospective, multi-center, observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) in participants with previously untreated chronic hepatitis C, genotype 2, 3, 1 or 4, who are undergoing opioid maintenance therapy. Data will be collected from eligible participants receiving Pegasys and Copegus treatment as prescribed by treating physician and treatment-free follow-up period of 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virological Response 24 Weeks After Completing Treatment (SVR24) | SVR24 is defined as percentage of participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment, using a last observation carried forward (LOCF) approach. Percentage is based on the number of non-missing observations (total). | 24 weeks after completing treatment, within 3 years, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With SVR 12 | SVR 12 is defined as percentage of participants with undetectable HCV RNA 12 weeks after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total). | 12 weeks after completing treatment, within 3 years, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with chronic hepatitis C (CHC), Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lkh Hoergas-Enzenbach; Abt. Für Innere Medizin | Gratwein | 8112 | Austria | |||
| Lkh-Univ. Klinikum Graz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28900714 | Derived | Gschwantler M, Laferl H, Vogel W, Korak W, Moser S, Hofer H, Bauer B, Schleicher M, Bognar B, Bischof M, Stauber R, Maieron A, Ferenci P; Austrian Hepatitis Study Group. Efficacy of peginterferon plus ribavirin in patients receiving opioid substitution therapy : Final results of the Austrian PegHope study. Wien Klin Wochenschr. 2018 Jan;130(1-2):54-61. doi: 10.1007/s00508-017-1263-2. Epub 2017 Sep 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Percentage of Participants With End of Treatment Response |
A participant was considered to have end of treatment response if there was undetectable HCV RNA after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total). |
| at end of treatment, within 3 years, 6 months |
| Percentage of Participants With Virological Relapse | Virological relapse is defined as no SVR24 in a participant with undetectable HCV RNA at end of treatment who has at least one post-treatment polymerase chain reaction (PCR) result available, using a LOCF approach. Percentage is based on the number of non-missing observations (total). | by end of follow-up, within 3 years, 6 months |
| Short Form Health Survey (SF-36) Scores by Visit | The SF-36 questionnaire items were scored and transformed according to the SF-36 Health Survey Manual & Interpretation Guide. Summary scores for SF-36 dimensions of physical functioning, role functioning, bodily pain, general health, vitality, social functioning, and mental health were scored on a scale of 0 (worst) to 100 (best), and health transition was scored on a scale of 0 (worst) to 5 (best). Summary SF-36 scores are reported by category and by visit. | at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months |
| Fatigue Severity Scale (FSS) Score by Visit | The Fatigue Severity Scale (FSS) consists of 9 questions, each answered within a range of 1-7, where lower scores indicate less fatigue in everyday life. The FSS score is the mean of the 9 numbers. Mean scores are presented by visit. | at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months |
| Beschwerdeliste (BL) Score by Visit | The BL questionnaire items were scored by calculating the average response to all answered items. Items can be 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. Mean scores are presented by visit. | at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months |
| Beck Depression Inventory (BDI) Score by Visit | The BDI questionnaire items were scored by generating the sum of the responses to all answered items. Each result was categorized into one of four categories: 0-13= no depression or clinically not significant or in remission; 14-19= mild depression; 20-28= moderate depression; or 29-63= severe depression. Mean scores are presented by visit. | at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months |
| Graz |
| 8036 |
| Austria |
| Lkh innsbruck - univ. Klinikum innsbruck - Tiroler landeskrankenanstalten ges.m.b.h.; Innere Medizin | Innsbruck | 6020 | Austria |
| Klinikum Klagenfurt am Wörthersee; 2. Medizinische Abteilung | Klagenfurt | 9020 | Austria |
| A.Ö. Krankenhaus Der Elisabethinen Linz; Iv. Med. Abtl. | Linz | 4010 | Austria |
| Gesundheitszentrum Wien Mitte | Vienna | 1030 | Austria |
| Krankenanstalt Rudolfstiftung; Iv. Med. Abtl. | Vienna | 1030 | Austria |
| Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie | Vienna | 1090 | Austria |
| Kaiser Franz Josef Spital; Iv. Medizinische Abt. | Vienna | 1100 | Austria |
| Wilhelminenspital; 6. Medizinische Abteilung Wilhelminenspital; 6. Medizinische Abteilung | Vienna | 1160 | Austria |
| Intention to Treat |
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| Safety Population |
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| Per Protocol |
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| Completed Treatment |
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| Completed Follow-up |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Percentage of Participants With Sustained Virological Response 24 Weeks After Completing Treatment (SVR24) | SVR24 is defined as percentage of participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment, using a last observation carried forward (LOCF) approach. Percentage is based on the number of non-missing observations (total). | Posted | Number | 95% Confidence Interval | percentage of participants | 24 weeks after completing treatment, within 3 years, 6 months |
|
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With SVR 12 | SVR 12 is defined as percentage of participants with undetectable HCV RNA 12 weeks after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total). | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after completing treatment, within 3 years, 6 months |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With End of Treatment Response | A participant was considered to have end of treatment response if there was undetectable HCV RNA after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total). | Posted | Number | 95% Confidence Interval | percentage of participants | at end of treatment, within 3 years, 6 months |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virological Relapse | Virological relapse is defined as no SVR24 in a participant with undetectable HCV RNA at end of treatment who has at least one post-treatment polymerase chain reaction (PCR) result available, using a LOCF approach. Percentage is based on the number of non-missing observations (total). | Participants who completed treatment | Posted | Number | 95% Confidence Interval | percentage of participants | by end of follow-up, within 3 years, 6 months |
|
| ||||||||||||||||||||||||||
| Secondary | Short Form Health Survey (SF-36) Scores by Visit | The SF-36 questionnaire items were scored and transformed according to the SF-36 Health Survey Manual & Interpretation Guide. Summary scores for SF-36 dimensions of physical functioning, role functioning, bodily pain, general health, vitality, social functioning, and mental health were scored on a scale of 0 (worst) to 100 (best), and health transition was scored on a scale of 0 (worst) to 5 (best). Summary SF-36 scores are reported by category and by visit. | Participants with a viable score at the given time point | Posted | Mean | Standard Deviation | units on a scale | at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months |
| |||||||||||||||||||||||||||
| Secondary | Fatigue Severity Scale (FSS) Score by Visit | The Fatigue Severity Scale (FSS) consists of 9 questions, each answered within a range of 1-7, where lower scores indicate less fatigue in everyday life. The FSS score is the mean of the 9 numbers. Mean scores are presented by visit. | Participants with a viable score at the given time point | Posted | Mean | Standard Deviation | units on a scale | at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months |
|
| ||||||||||||||||||||||||||
| Secondary | Beschwerdeliste (BL) Score by Visit | The BL questionnaire items were scored by calculating the average response to all answered items. Items can be 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. Mean scores are presented by visit. | Participants with a viable score at the given time point | Posted | Mean | Standard Deviation | units on a scale | at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months |
|
| ||||||||||||||||||||||||||
| Secondary | Beck Depression Inventory (BDI) Score by Visit | The BDI questionnaire items were scored by generating the sum of the responses to all answered items. Each result was categorized into one of four categories: 0-13= no depression or clinically not significant or in remission; 14-19= mild depression; 20-28= moderate depression; or 29-63= severe depression. Mean scores are presented by visit. | Participants with a viable score at the given time point | Posted | Mean | Standard Deviation | units on a scale | at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months |
|
|
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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 | Safety Population | Participants who started treatment | 14 | 86 | 60 | 86 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess limb | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
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| Drug withdrawal syndrome | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Anorexia nervosa | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
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| Withdrawal syndrome | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA (18.1) | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Uterine cyst | Reproductive system and breast disorders | MedDRA (18.1) | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA (18.1) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 1-800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
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