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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-004993-15 |
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This study will evaluate the efficacy and safety of peginterferon alfa-2a 40KD + ribavirin combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3.
During a pre-study run-in phase patients with chronic hepatitis C genotype 2/3, who had started therapy with PEG-IFN alfa-2a plus ribavirin according to local standard of care and did not achieve a rapid viral response (RVR) (defined as Hepatitis C virus (HCV) RNA <15 IU/mL at Week 4 of treatment measured with the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test) were eligible for the study and entered the screening phase between treatment Week 4 and 8 as soon as the result of the Week 4 HCV RNA test was available.
Eligible patients entered the study and continued with the dose regimens of PEG-IFN alfa-2a and ribavirin they were taking prior to enrolment into the trial up to Week 24 of treatment. Patients who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24, were randomized at treatment Week 24 to one of the two study groups. Upon randomization, participants either stopped treatment (equaling 24 weeks of treatment) or continued treatment for another 24 weeks (equaling 48 weeks of treatment). A treatment free follow-up period of 24 weeks (for participants in the 48-week treatment group) or 48 weeks (participants in the 24-week treatment group) completed the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-IFN alfa-2a + Ribavirin for 24 weeks | Experimental | After 24 weeks of treatment with pegylated interferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period. |
|
| PEG-IFN alfa-2a + Ribavirin for 48 weeks | Active Comparator | After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peginterferon alfa-2a | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Sustained Virologic Response 24 Weeks After Scheduled Completion of Treatment | Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) 24 weeks after scheduled treatment completion, defined as Week 44 or later for participants randomized to the 24-week treatment period or Week 68 or later for participants randomized to the 48-week treatment period. Participants without measurements at the end of the 24-week untreated follow-up period were considered non-responders in the analysis. | 24 weeks after scheduled treatment completion (approximately Week 48 for participants in the 24-week treatment group and Week 72 for participants in the 48-week treatment group. |
| Percentage of Participants With a Sustained Virologic Response 24 Weeks After Actual End of Treatment | Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 24 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 24 weeks after actual end of treatment were used in the analysis. Participants without a 24-week post treatment measurement are considered non-responders. | 24 weeks after actual end of treatment (range from Week 48 to Week 72). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Virological Response 72 Weeks After Treatment Initiation | Virological response 72 weeks after treatment initiation is defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test at 48 weeks post completion of the 24 week treatment period and 24 weeks post completion of the 48 week treatment period. Participants without Week 72 measurements were considered non-responders in the analysis. |
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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 | |||
235 patients enrolled and continued with the dose regimens they were taking prior to enrolment up to Week 24 of treatment. Patients who achieved at least a 2-log10 drop of HCV RNA at Week 12 (compared to HCV RNA prior to treatment initiation) or had HCV RNA <15 IU/mL and who were still taking study medication at Week 24, were randomized at Week 24.
Patients with Chronic Hepatitis C, Genotype 2 or 3 who had started therapy with PEG-IFN alfa-2a plus ribavirin according to local standard of care during a pre-study run-in phase and did not achieve a rapid viral response defined as HCV RNA <15 IU/mL at Week 4 of treatment were eligible and entered the screening phase between treatment Weeks 4-8.
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| ID | Title | Description |
|---|---|---|
| FG000 | PEG-IFN Alfa-2a + Ribavirin for 24 Weeks | After 24 weeks of treatment with pegylated-interferon (peginterferon) alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
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| Ribavirin | Drug |
|
|
| Week 72 |
| Percentage of Participants With Virological Response at End of Treatment | Virological response at the end of treatment was defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test after the last dose of study medication. | End of Treatment (Week 24 and Week 48 for each treatment group respectively). |
| Percentage of Participants With Virological Relapse | Virological relapse defined as the percentage of participants with a virological response at end of treatment but who did not have a sustained virological response 24 weeks after the end of treatment. Virological response at end of treatment is defined as a single last HCV RNA measurement <15 IU/ml measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test at the day of last dose of study medication. Sustained virological response 24 weeks after the actual treatment end (SVR24) is defined as a single last HCV RNA measurement <15 IU/ml at least 20 weeks after treatment end. | End of treatment (Weeks 24 or 48) and 24 weeks after the end of treatment (weeks 48 and 72 in each treatment group respectively). |
| Percentage of Participants With a Sustained Virologic Response 12 Weeks After Actual End of Treatment | Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 12 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 12 weeks after actual end of treatment were used in the analysis. Participants without a 12-week post treatment measurement are considered non-responders. | 12 weeks after actual end of treatment (range from Week 36 to Week 60) |
| Number of Participants With Adverse Events (AEs) | An AE was defined as a sign or symptom, including intercurrent illness, that occurred during the course of the clinical study after treatment had started. A related AE is an event assessed by the Investigator to be remotely, possibly, or probably related to study treatment according to criteria provided in the protocol. A severe AE was an event graded by the Investigator as "incapacitating with inability to work or perform normal daily activity". A serious AE (SAE) was defined as any experience that suggests a significant hazard, contraindication, side effect or precaution. This includes any experience which was fatal; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/ birth defect; was medically significant or required intervention to prevent one or other of the outcomes listed above. | From Week 1 through Week 72. |
| La Jolla |
| California |
| 92037-1030 |
| United States |
| Lancaster | California | 93534 | United States |
| Long Beach | California | 90822 | United States |
| Los Angeles | California | 90048 | United States |
| Los Angeles | California | 90057 | United States |
| Sacramento | California | 95816 | United States |
| Sacramento | California | 95817 | United States |
| San Diego | California | 92103-8465 | United States |
| Torrance | California | 90505 | United States |
| Aurora | Colorado | 80045 | United States |
| Jacksonville | Florida | 32256 | United States |
| Orlando | Florida | 32803 | United States |
| Atlanta | Georgia | 30308 | United States |
| Marietta | Georgia | 30060 | United States |
| Honolulu | Hawaii | 96813 | United States |
| Baton Rouge | Louisiana | 70890 | United States |
| Opelousas | Louisiana | 70520 | United States |
| Boston | Massachusetts | 02114 | United States |
| Tupelo | Mississippi | 38801 | United States |
| St Louis | Missouri | 63104 | United States |
| St Louis | Missouri | 63110 | United States |
| Egg Harbour Township | New Jersey | 08234 | United States |
| Hackensack | New Jersey | 07601 | United States |
| Albuquerque | New Mexico | 87131 | United States |
| New York | New York | 10016 | United States |
| Syracuse | New York | 13210 | United States |
| Asheville | North Carolina | 28801 | United States |
| Chapel Hill | North Carolina | 27599-7080 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Oklahoma City | Oklahoma | 73112-4481 | United States |
| Portland | Oregon | 97239 | United States |
| Kingsport | Tennessee | 37660 | United States |
| Fort Sam Houston | Texas | 78234-3879 | United States |
| Salt Lake City | Utah | 84132 | United States |
| Charlottesville | Virginia | 22908 | United States |
| Fairfax | Virginia | 22031 | United States |
| Richmond | Virginia | 23249 | United States |
| Darlinghurst | 2010 | Australia |
| Fremantle | 6160 | Australia |
| Melbourne | 3186 | Australia |
| Nedlands | 6009 | Australia |
| Sydney | 2139 | Australia |
| Graz | 8036 | Austria |
| Innsbruck | 6020 | Austria |
| Linz | 4010 | Austria |
| Oberndorf | 5110 | Austria |
| Vienna | 1090 | Austria |
| Vienna | 1160 | Austria |
| Antwerp | 2650 | Belgium |
| Brussels | 1000 | Belgium |
| Brussels | 1020 | Belgium |
| Brussels | 1070 | Belgium |
| Ghent | 9000 | Belgium |
| Kortrijk | 8500 | Belgium |
| Liège | 4000 | Belgium |
| Brasília | 70335-000 | Brazil |
| Campinas | 13012-970 | Brazil |
| Campinas | 13081-970 | Brazil |
| Porto Alegre | 90020-090 | Brazil |
| Porto Alegre | 90035-003 | Brazil |
| Ribeirão Preto | 14049-900 | Brazil |
| Rio de Janeiro | 20020-022 | Brazil |
| Santo André | 09060-650 | Brazil |
| São Luís | 78048-790 | Brazil |
| São Paulo | 04040-003 | Brazil |
| Sorocaba | 18047-600 | Brazil |
| Vitória | 29043-260 | Brazil |
| Edmonton | Alberta | T6G 2B7 | Canada |
| Vancouver | British Columbia | V6Z 2K5 | Canada |
| Hamilton | Ontario | L8N 4A6 | Canada |
| Mississauga | Ontario | L5M 4N4 | Canada |
| Berlin | 10969 | Germany |
| Berlin | 13353 | Germany |
| Bonn | 53127 | Germany |
| Cologne | 50937 | Germany |
| Düsseldorf | 40225 | Germany |
| Düsseldorf | 40237 | Germany |
| Frankfurt am Main | 60590 | Germany |
| Freiburg im Breisgau | 79106 | Germany |
| Giessen | 35392 | Germany |
| Hamburg | 20099 | Germany |
| Heidelberg | 69120 | Germany |
| Jena | 07747 | Germany |
| Kiel | 24105 | Germany |
| Mainz | 55101 | Germany |
| München | 81675 | Germany |
| Offenburg | 77654 | Germany |
| Tübingen | 72076 | Germany |
| Ulm | 89081 | Germany |
| Guadalajara | 44160 | Mexico |
| Guadalajara | 44670 | Mexico |
| Mexicali | 21000 | Mexico |
| Mexico City | 11649 | Mexico |
| Mexico City | 14050 | Mexico |
| Puebla City | 72560 | Mexico |
| Santurce | 00909 | Puerto Rico |
| Lausanne | 1005 | Switzerland |
| Lugano | 6903 | Switzerland |
| Sankt Gallen | 9007 | Switzerland |
| Zurich | 8091 | Switzerland |
| FG001 | PEG-IFN Alfa-2a + Ribavirin for 48 Weeks | After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-up Period |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PEG-IFN Alfa-2a + Ribavirin for 24 Weeks | After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period. |
| BG001 | PEG-IFN Alfa-2a + Ribavirin for 48 Weeks | After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period. |
| 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 |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Hepatitis C virus (HCV) genotype | Number | participants |
| ||||||||||||||||
| Pre-treatment HCV ribonucleic acid (RNA) | Mean | Standard Deviation | log10 IU/mL |
| |||||||||||||||
| Region | Region (US and non-US) was used for stratification. | Number | 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 a Sustained Virologic Response 24 Weeks After Scheduled Completion of Treatment | Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) 24 weeks after scheduled treatment completion, defined as Week 44 or later for participants randomized to the 24-week treatment period or Week 68 or later for participants randomized to the 48-week treatment period. Participants without measurements at the end of the 24-week untreated follow-up period were considered non-responders in the analysis. | All randomized patients. | Posted | Number | percentage of participants | 24 weeks after scheduled treatment completion (approximately Week 48 for participants in the 24-week treatment group and Week 72 for participants in the 48-week treatment group. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virological Response 72 Weeks After Treatment Initiation | Virological response 72 weeks after treatment initiation is defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test at 48 weeks post completion of the 24 week treatment period and 24 weeks post completion of the 48 week treatment period. Participants without Week 72 measurements were considered non-responders in the analysis. | All randomized patients. | Posted | Number | percentage of participants | Week 72 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virological Response at End of Treatment | Virological response at the end of treatment was defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test after the last dose of study medication. | All randomized patients. A backward imputation approach was used when the HCV RNA measurement at end of treatment was missing and HCV RNA was <15 IU/mL at the first measurement after the end of treatment time window (the patient was regarded as having virological response at end of treatment). | Posted | Number | percentage of participants | End of Treatment (Week 24 and Week 48 for each treatment group respectively). |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virological Relapse | Virological relapse defined as the percentage of participants with a virological response at end of treatment but who did not have a sustained virological response 24 weeks after the end of treatment. Virological response at end of treatment is defined as a single last HCV RNA measurement <15 IU/ml measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test at the day of last dose of study medication. Sustained virological response 24 weeks after the actual treatment end (SVR24) is defined as a single last HCV RNA measurement <15 IU/ml at least 20 weeks after treatment end. | Randomized patients with virological response at the end of treatment and at least one post-treatment HCV RNA measurement. | Posted | Number | percentage of participants | End of treatment (Weeks 24 or 48) and 24 weeks after the end of treatment (weeks 48 and 72 in each treatment group respectively). |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With a Sustained Virologic Response 24 Weeks After Actual End of Treatment | Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 24 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 24 weeks after actual end of treatment were used in the analysis. Participants without a 24-week post treatment measurement are considered non-responders. | All randomized patients. | Posted | Number | percentage of participants | 24 weeks after actual end of treatment (range from Week 48 to Week 72). |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Sustained Virologic Response 12 Weeks After Actual End of Treatment | Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 12 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 12 weeks after actual end of treatment were used in the analysis. Participants without a 12-week post treatment measurement are considered non-responders. | All randomized patients. | Posted | Number | percentage of participants | 12 weeks after actual end of treatment (range from Week 36 to Week 60) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) | An AE was defined as a sign or symptom, including intercurrent illness, that occurred during the course of the clinical study after treatment had started. A related AE is an event assessed by the Investigator to be remotely, possibly, or probably related to study treatment according to criteria provided in the protocol. A severe AE was an event graded by the Investigator as "incapacitating with inability to work or perform normal daily activity". A serious AE (SAE) was defined as any experience that suggests a significant hazard, contraindication, side effect or precaution. This includes any experience which was fatal; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/ birth defect; was medically significant or required intervention to prevent one or other of the outcomes listed above. | Posted | Number | participants | From Week 1 through Week 72. |
|
72 weeks.
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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-IFN Alfa-2a + Ribavirin for 24 Weeks | After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period. | 4 | 95 | 81 | 95 | ||
| EG001 | PEG-IFN Alfa-2a + Ribavirin for 48 Weeks | After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period. | 11 | 93 | 87 | 93 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychotic disorder | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Alcohol abuse | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pyloric stenosis | Congenital, familial and genetic disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Mesangioproliferative glomerulonephritis | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (15.0) | 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 | Hoffman-LaRoche | 800-821-8590 |
| 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 |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Patient withdrew consent |
|
| HCV-RNA detectable at end of treatment |
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| Did not cooperate |
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| Reason not specified |
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| Death |
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| > 50 years |
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| Male |
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| Black |
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| Asian or oriental |
|
| Other |
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| HCV Genotype 3 |
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| U.S. |
|
| Superiority or Other |
|
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|
| PEG-IFN Alfa-2a + Ribavirin for 48 Weeks |
After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period. |
|
|
|
|
|
|
|
|
| PEG-IFN Alfa-2a + Ribavirin for 48 Weeks |
After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period. |
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