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This study will evaluate the efficacy and safety of different durations of treatment with PEGASYS combined with ribavirin in patients with CHC genotype 2 or 3 infection who have never previously received interferon (IFN) therapy. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copegus | Drug | 400mg po bid for 16 weeks |
| |
| Copegus |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virological Response (SVR) | SVR was defined as the percentage of participants with undetectable HCV RNA at 24 weeks after the completion of the study treatment. The negative assessment was required to be the last one collected at or after week 36 (ie, on or after study Day 253) for the 16-week treatment group or at or after week 44 (ie, on or after study Day 309) for the 24-week treatment group. | Week 40 (for 16-week treatment group); Week 48 (for 24-week treatment group) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Virological Response at The End of Study Treatment | Virological response was defined as the percentage of participants with undetectable HCV RNA at the completion of the study treatment. The negative assessment was required to be the last one collected in the Week 16 time window for the 16-week treatment group or in the Week 24 time window for the 24-week treatment group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17625124 | Derived | Shiffman ML, Suter F, Bacon BR, Nelson D, Harley H, Sola R, Shafran SD, Barange K, Lin A, Soman A, Zeuzem S; ACCELERATE Investigators. Peginterferon alfa-2a and ribavirin for 16 or 24 weeks in HCV genotype 2 or 3. N Engl J Med. 2007 Jul 12;357(2):124-34. doi: 10.1056/NEJMoa066403. |
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A total of 1400 participants were planned for the study; 1469 were randomized (736 were assigned to the 16-week treatment group and 733 were assigned to the 24-week treatment group) and 1465 received the study treatment.
The study was conducted in 8 countries from 20 November 2003 to 13 September 2005.
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| ID | Title | Description |
|---|---|---|
| FG000 | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks | Participants received 180 micrograms (mcg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks. |
| FG001 | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
400mg po bid for 24 weeks |
|
| peginterferon alfa-2a [Pegasys] | Drug | 180 micrograms sc weekly for 16 weeks |
|
| peginterferon alfa-2a [Pegasys] | Drug | 180 micrograms sc weekly for 24 weeks |
|
| Week 16 (for 16-week treatment group); Week 24 (for 24-week treatment group) |
| Percentage of Participants Virological Response 12 Weeks Post-Treatment | Virological response 12 weeks post-treatment was defined as the percentage of participants with undetectable HCV RNA 12 weeks after the completion of the study treatment . The negative assessment was required to be the last one collected in the week 28 time window for the 16- week treatment group or in the week 36 time window for the 24-week treatment group. | Week 28 (for 16-week treatment group); Week 36 (for 24-week treatment group) |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An adverse event was defined as any untoward medical occurrence that occurred during he course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. | Up to Week 40 and Week 48 |
| Percentage of Participants With Marked Laboratory Abnormalities | Participants with changes in Hematocrit: Fraction 0.36 - 0.60 g/dL, Hemoglobin: 11.0 -20.0 g/dL, WBC 3.0 - 18.0 g/dL, Platelets 100 - 700 g/dL, Basophils 0.00 - 0.30 g/dL, Lymphocytes 1.00 - 6.30 g/dL, Monocytes 0.08 - 2.00 g/dL, Neutrophils 1.50 or more g/dL, Eosinophils 0.00 - 1.50 g/dL , PTT 0 - 50 seconds, Alkaline Phosphatase 0 - 190 and ASAT 0 - 50 U/L, ALAT 0 - 60 U/L, Gamma - GT 0 - 120 U/L, Total Protein 55 - 87 g/L ;Albumin 27.0 or more g/L, Total Bilirubin 0 - 34.2 μmol/L, BUN 0 - 14.3 mmol/L, Creatinine 0 - 154 μmol/L, Free T3, T4 5 - 40 pmol/L, TSH 0.0 - 10.0 mU/L, Cholesterol 0.0 - 8.3 mmol/L; Triglycerides 0.00 - 2.83 mmol/L, Chloride 95 - 115 mmol/L; Potassium 3.0 - 6.0 mmol/L; Sodium 130 - 150 mmol/L, miscellaneous: Calcium 2.00 - 2.90 mmol/L; Phosphate 0.75 - 1.60 mmol/L; Blood Glucose (Random) 2.80 - 11.10 mmol/L, Uric Acid 0 - 600 μmol/L, Proteinuria, Glycosuria, Hematuria (Qualitative 0 to 4+) 0 - 1 were analysed for the laboratory abnormality. | Up to Week 40 and Week 48 |
| Participants With Marked Abnormal Vital Signs | Participants with changes in Systolic and diastolic blood pressure, heart rate were analysed abnormal vital signs. | Up to Week 40 and Week 48 |
| Number of Participants With Highest Triglyceride Level | Participants with triglyceride level above normal (i.e. < 200 mg/dL) were analysed. | Up to Week 40 and Week 48 |
| Mobile |
| Alabama |
| 36693 |
| United States |
| Anchorage | Alaska | 99508 | United States |
| Phoenix | Arizona | 85006 | United States |
| Scottsdale | Arizona | 85259 | United States |
| Little Rock | Arkansas | 72205 | United States |
| La Jolla | California | 92037-1030 | United States |
| Long Beach | California | 90822 | United States |
| Los Angeles | California | 90048 | United States |
| Palo Alto | California | 94304-1509 | United States |
| Sacramento | California | 95825-2115 | United States |
| San Diego | California | 92105 | United States |
| San Diego | California | 92123 | United States |
| San Diego | California | 92154 | United States |
| San Francisco | California | 94115 | United States |
| San Francisco | California | 94121 | United States |
| San Luis Obispo | California | 93401 | United States |
| Littleton | Colorado | 80120 | United States |
| Farmington | Connecticut | 06030 | United States |
| Bradenton | Florida | 34209 | United States |
| Gainesville | Florida | 32610-0214 | United States |
| Jacksonville | Florida | 32207 | United States |
| Jacksonville | Florida | 32209 | United States |
| Miami | Florida | 33136 | United States |
| Orlando | Florida | 32803 | United States |
| Pensacola | Florida | 32514 | United States |
| Tampa | Florida | 33612 | United States |
| Wellington | Florida | 33414 | United States |
| Atlanta | Georgia | 30309 | United States |
| Austell | Georgia | 30106 | United States |
| Honolulu | Hawaii | 96817 | United States |
| Boise | Idaho | 83702 | United States |
| Moline | Illinois | 61265 | United States |
| Indianapolis | Indiana | 46202 | United States |
| Iowa City | Iowa | 52242 | United States |
| Iowa City | Iowa | 52246 | United States |
| Baton Rouge | Louisiana | 70805 | United States |
| New Orleans | Louisiana | 70112 | United States |
| Baltimore | Maryland | 21201 | United States |
| Baltimore | Maryland | 21205 | United States |
| Boston | Massachusetts | 02118 | United States |
| Boston | Massachusetts | 02720 | United States |
| Burlington | Massachusetts | 01805 | United States |
| Worcester | Massachusetts | 01655 | United States |
| Ann Arbor | Michigan | 48109-0362 | United States |
| Detroit | Michigan | 48202-2689 | United States |
| Minneapolis | Minnesota | 55417 | United States |
| Plymouth | Minnesota | 55446 | United States |
| St Louis | Missouri | 63104 | United States |
| Albuquerque | New Mexico | 87108 | United States |
| Bayside | New York | 11358 | United States |
| Binghamton | New York | 13903 | United States |
| Manhasset | New York | 11030 | United States |
| New York | New York | 10003 | United States |
| New York | New York | 10021 | United States |
| The Bronx | New York | 10468 | United States |
| Williamsville | New York | 14221 | United States |
| Chapel Hill | North Carolina | 27599-7584 | United States |
| Durham | North Carolina | 27710 | United States |
| Fayetteville | North Carolina | 28304 | United States |
| Statesville | North Carolina | 28677 | United States |
| Cincinnati | Ohio | 45267-0595 | United States |
| Cleveland | Ohio | 44106 | United States |
| Portland | Oregon | 97220 | United States |
| Hershey | Pennsylvania | 17033 | United States |
| Lancaster | Pennsylvania | 17604-3200 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Cranston | Rhode Island | 02920 | United States |
| Providence | Rhode Island | 02905 | United States |
| Germantown | Tennessee | 38138 | United States |
| Dallas | Texas | 75203 | United States |
| Dallas | Texas | 75235-9151 | United States |
| Fort Sam Houston | Texas | 78234-3879 | United States |
| Houston | Texas | 77030 | United States |
| Salt Lake City | Utah | 84121 | United States |
| White River Junction | Vermont | 05009-0001 | United States |
| Charlottesville | Virginia | 22902 | United States |
| Chesapeake | Virginia | 23320-1706 | United States |
| Falls Church | Virginia | 22042 | United States |
| Richmond | Virginia | 23249 | United States |
| Bellevue | Washington | 98004 | United States |
| Kirkland | Washington | 98034 | United States |
| Puyallup | Washington | 98372 | United States |
| Seattle | Washington | 98133 | United States |
| Seattle | Washington | 98195 | United States |
| Spokane | Washington | 99220-3649 | United States |
| Madison | Wisconsin | 53792 | United States |
| Cheyenne | Wyoming | 82001 | United States |
| Adelaide | 5000 | Australia |
| Brisbane | 4029 | Australia |
| Kingswood | Australia |
| Melbourne | 3181 | Australia |
| Woolloongabba | 4102 | Australia |
| Edmonton | Alberta | T6G 2B7 | Canada |
| Downsview | Ontario | M3N 2V7 | Canada |
| Mississauga | Ontario | L5M 2V8 | Canada |
| Clichy | 92118 | France |
| Créteil | 94010 | France |
| La Tronche | 38700 | France |
| Marseille | 13285 | France |
| Nice | 06202 | France |
| Rennes | 35033 | France |
| Strasbourg | 67091 | France |
| Toulouse | 31059 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Berlin | 13353 | Germany |
| Düsseldorf | 40225 | Germany |
| Freiburg im Breisgau | 79106 | Germany |
| Hanover | 30625 | Germany |
| Homburg/saar | 66424 | Germany |
| Kiel | 24105 | Germany |
| Bergamo | 24128 | Italy |
| Bologna | 40138 | Italy |
| Milan | 20121 | Italy |
| Naples | 80131 | Italy |
| Pavia | 27100 | Italy |
| Pisa | 56124 | Italy |
| Otahuhu | New Zealand |
| Ponce | 00716 | Puerto Rico |
| San Juan | 00921-3200 | Puerto Rico |
| San Juan | 00936-5067 | Puerto Rico |
| Santurce | 00909 | Puerto Rico |
| Badalona | 08915 | Spain |
| Barakaldo | 48903 | Spain |
| Barcelona | 08003 | Spain |
| Barcelona | 08025 | Spain |
| Madrid | 08029 | Spain |
| Madrid | 28006 | Spain |
| Madrid | 28007 | Spain |
| Madrid | 28034 | Spain |
| Seville | 41013 | Spain |
| Valencia | 46014 | Spain |
Participants received 180 mcg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks | Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks. |
| BG001 | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks | Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks. |
| BG002 | Total | Total of all reporting groups |
| 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 |
|
| 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 (SVR) | SVR was defined as the percentage of participants with undetectable HCV RNA at 24 weeks after the completion of the study treatment. The negative assessment was required to be the last one collected at or after week 36 (ie, on or after study Day 253) for the 16-week treatment group or at or after week 44 (ie, on or after study Day 309) for the 24-week treatment group. | Standard population: The standard population includes all randomized participants who received at least one dose of study medication and who did not have any of the major protocol violations or deviations. | Posted | Number | percentage of participants | Week 40 (for 16-week treatment group); Week 48 (for 24-week treatment group) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virological Response at The End of Study Treatment | Virological response was defined as the percentage of participants with undetectable HCV RNA at the completion of the study treatment. The negative assessment was required to be the last one collected in the Week 16 time window for the 16-week treatment group or in the Week 24 time window for the 24-week treatment group. | Standard population: The standard population included all randomized participants who received at least one dose of study medication and who did not have any of the major protocol violations or deviations. | Posted | Number | Percentage of participants | Week 16 (for 16-week treatment group); Week 24 (for 24-week treatment group) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Virological Response 12 Weeks Post-Treatment | Virological response 12 weeks post-treatment was defined as the percentage of participants with undetectable HCV RNA 12 weeks after the completion of the study treatment . The negative assessment was required to be the last one collected in the week 28 time window for the 16- week treatment group or in the week 36 time window for the 24-week treatment group. | Standard population: The standard population included all randomized participants who received at least one dose of study medication and who did not have any of the major protocol violations or deviations. | Posted | Number | Percentage of participants | Week 28 (for 16-week treatment group); Week 36 (for 24-week treatment group) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An adverse event was defined as any untoward medical occurrence that occurred during he course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. | Safety population: The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment. | Posted | Number | Percentage of participants | Up to Week 40 and Week 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Marked Laboratory Abnormalities | Participants with changes in Hematocrit: Fraction 0.36 - 0.60 g/dL, Hemoglobin: 11.0 -20.0 g/dL, WBC 3.0 - 18.0 g/dL, Platelets 100 - 700 g/dL, Basophils 0.00 - 0.30 g/dL, Lymphocytes 1.00 - 6.30 g/dL, Monocytes 0.08 - 2.00 g/dL, Neutrophils 1.50 or more g/dL, Eosinophils 0.00 - 1.50 g/dL , PTT 0 - 50 seconds, Alkaline Phosphatase 0 - 190 and ASAT 0 - 50 U/L, ALAT 0 - 60 U/L, Gamma - GT 0 - 120 U/L, Total Protein 55 - 87 g/L ;Albumin 27.0 or more g/L, Total Bilirubin 0 - 34.2 μmol/L, BUN 0 - 14.3 mmol/L, Creatinine 0 - 154 μmol/L, Free T3, T4 5 - 40 pmol/L, TSH 0.0 - 10.0 mU/L, Cholesterol 0.0 - 8.3 mmol/L; Triglycerides 0.00 - 2.83 mmol/L, Chloride 95 - 115 mmol/L; Potassium 3.0 - 6.0 mmol/L; Sodium 130 - 150 mmol/L, miscellaneous: Calcium 2.00 - 2.90 mmol/L; Phosphate 0.75 - 1.60 mmol/L; Blood Glucose (Random) 2.80 - 11.10 mmol/L, Uric Acid 0 - 600 μmol/L, Proteinuria, Glycosuria, Hematuria (Qualitative 0 to 4+) 0 - 1 were analysed for the laboratory abnormality. | Safety population: The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment. | Posted | Number | Percentage of participants | Up to Week 40 and Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Participants With Marked Abnormal Vital Signs | Participants with changes in Systolic and diastolic blood pressure, heart rate were analysed abnormal vital signs. | Safety population: The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment. | Posted | Number | participants | Up to Week 40 and Week 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Highest Triglyceride Level | Participants with triglyceride level above normal (i.e. < 200 mg/dL) were analysed. | The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment. | Posted | Number | participants | Up to Week 40 and Week 48 |
|
|
Up to week 48
An adverse event 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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks | Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks. | 34 | 731 | 696 | 731 | ||
| EG001 | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks | Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks. | 47 | 728 | 713 | 728 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| Chronic tonsillitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| Keratitis herpetic | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Appendicitis perforated | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Volvulus of bowel | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Drug dependence | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Homicidal ideation | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
| |
| Cervical vertebra injury | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
| |
| Limb crushing injury | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
| |
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Mononeuropathy multiplex | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Optic ischaemic neuropathy | Eye disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Retinal artery thrombosis | Eye disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Retinal exudates | Eye disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Tonsil cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
| |
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
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 | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 616878333 | global.trial_information@roche.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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D012254 | Ribavirin |
| C100416 | peginterferon alfa-2a |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Male |
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| Participants |
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| Participants |
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Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks. |
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