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The effects of treatment with different doses of PEGASYS in combination with different doses of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer, body weight greater than 85kg (187lbs) and no prior treatment with interferon. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-IFN Alfa-2a 180 μg +Ribavirin 1200 mg | Active Comparator | Participants received 180 μg of PEG-IFN [peginterferon] alfa-2a in 1 mL solution administered [subcutaneously] sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks |
|
| PEG-IFN Alfa-2a 180 μg + Ribavirin 1600 mg | Experimental | Participants received 180 μg of PEG-IFN [peginterferon] alfa-2a in 1 mL solution administered [subcutaneously] sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks |
|
| PEG-IFN Alfa-2a 270 μg + Ribavirin 1200 mg | Experimental | Participants received 270 μg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks |
|
| PEG-IFN Alfa-2a 270 μg + Ribavirin 1600 mg | Experimental | Participants received 270 μg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ribavirin [Copegus] | Drug | 600mg po bid for 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| HCV RNA Profile During The First 24 Weeks | Viral loads (quantitative HCV RNA) collected during the initial 24 weeks were first logarithmically (based 10) transformed. Results falling below the assay sensitivity level were set to the assay sensitivity level before the analyses. Thus, a qualitative HCV RNA negative result was set to 50 IU/mL (or 100 copies/mL). A qualitative HCV RNA positive result along with an unquantifiable HCV RNA result from the quantitative assay corresponded to a numeric HCV RNA result of 600 IU/mL (or 1000 copies/mL). | Baseline (Day 1), At 72 hour (h), Week (W)-1, 2, 4, 12, 24 |
| Percentage of Participants With Virological Response Over Time to Week 24 | Virological response over time to Week 24 is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, V. 2.0 (detection limit = 50 IU/mL) at 72 hours and at weeks 1, 2, 12, and 24. | 72 hours post-dose, Weeks 1, 2, 4, 12, and 24 |
| Percentage of Participants With Predicted Sustained Virological Response | The predicted sustained virological response (SVR) for each treatment group, is determined using a model based on the log10-transformed HCV viral load in copies/mL at Week 4 and the virological response status at Week 12. Each participant was classified as a predicted SVR if p was ≥ 0.5 or as a non-SVR if p was <0.5. The percentage was calculated from the number of participant (N) analyzed under "Distribution of the predicted probability of an SVR." | Week 4 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virological Response | SVR is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/ml) at the end of the 24-week untreated follow-up period. | Week 72 |
| Percentage of Participants With Virological Response at the End of the Treatment Period |
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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 |
|---|---|---|---|---|---|---|
| La Jolla | California | 92037-1030 | United States | |||
Number of participants who completed and did not complete the 48 weeks of treatment are presented in the table .
A total of 188 participants were enrolled in the study which was conducted at 23 centers in the United States from 13 January 2004 to 06 December 2005
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| ID | Title | Description |
|---|---|---|
| FG000 | PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg | Participants received 180 micrograms (mcg) of PEG-IFN [peginterferon] alfa-2a in 1 milliliter (mL) solution administered subcutaneously (SC), once weekly + 1200 milligrams (mg) of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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Not provided
|
| ribavirin [Copegus] | Drug | 800mg po bid for 48 weeks |
|
| peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys] | Drug | 180 micrograms sc weekly for 48 weeks |
|
| peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys] | Drug | 270 micrograms sc weekly for 48 weeks |
|
Virological response at the end of the treatment period is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/mL) at the completion of the treatment period. |
| Week 48 |
| Percentage of Participants With Virological Response At 12 Weeks After The End of The Treatment Period | Virological response at 12 weeks after the end of the treatment period is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/mL) at 12 weeks after completion of the treatment period. | Week 60 |
| Percentage of Participants With Adverse Events and Serious Adverse Events | An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. A serious adverse event is any adverse event (SAE) that can result in death or is Life-threatening or required in-patient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above. | Up to Week 72 |
| Percentage of Participants With Marked Laboratory Abnormalities | Marked laboratory abnormalities are the values outside the roche defined reference range.It is hemoglobin 11.0 - 20.0 (g/dL),platelets 100 - 700 (10^9/L), lymphocyte 1.00 - 6.30 (10^9/L),neutrophils 1.50 or more (10^9/L), white blood cells(WBC) 3.0 - 18.0 (10^9/L),serum glutamic-pyruvic transaminase (SGPT) 0 - 60 (U/L), serum glutamic oxaloacetic transaminase (SGOT) 0 - 50 (U/L), alkaline phosphatase 0 - 190 (U/L),albumin was 27.0 or more (g/L),gamma glutamyl transferases (GGT) 0 - 120 (U/L),Total protein 55 - 87 (g/L),total bilirubin 0 - 34.2 (μmol/L),BUN 0 - 14.3 (mmol/L),creatinine 0 - 154 (μmol/L),chloride 95 - 115 (mmol/L),potassium 3.0 - 6.0 (mmol/L), sodium 130 - 150 (mmol/L),thyroid stimulating hormone (TSH) 0.0 - 10.0 (mU/L),triglycerides 0.00 - 2.83 (mmol/L), calcium 2.00 - 2.90 (mmol/L),phosphate 0.75 - 1.60 (mmol/L),Blood Glucose 2.80 - 11.10 (mmol/L),Uric Acid 0 - 600 (μmol/L),proteinuria 0 - 1 (0 to 4+), glycosuria 0 - 1 (0 to 4+), hematuria 0 - 1 (0 to 4+). | Up to Week 60 |
| Percentage of Participants With Abnormal Vital Signs | Vital signs (Systolic blood pressure, Diastolic blood pressure, Pulse rate) were considered to be abnormal and of potential clinical relevance if the values measured for these parameters represented a change from baseline of greater than 20% in the direction of worsening. High diastolic blood pressure is defined as >110 mmhg and >20% increase from baseline. High systolic blood pressure is defined as >180 mmhg and >20% increase from baseline. Low systolic blood pressure is defined as <85 mmhg and >20% decrease from baseline. High heart rate is defined as >120 beats/minute and >20% increase from baseline. Low heart rate is defined as < 50 beats/minute and >20% decrease from baseline. | Up to Week 72 |
| Total BDI-II (Beck Depression Inventory) Scores | The BDI-II is a self-reported assessment of 21 items which included sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, loss of interest in sex that are summarized by treatment group. All except two items had four statements that were scored on a scale ranging from 0 to 3. The maximum total score was 63. The scores for each item were summed to obtain the total for that assessment. The participants neurological status could then be categorized as follows: minimal depression: 0 to 13; mild depression: 14 to 19; moderate depression: 20 to 28; and severe depression: 29 to 63. The BDI-II questionnaire was self-administered by the patient at each visit. | From Baseline (Day 1) to Week 72 |
| Long Beach |
| California |
| 90822 |
| United States |
| San Diego | California | 92105 | United States |
| San Diego | California | 92154 | United States |
| Farmington | Connecticut | 06030 | United States |
| Bradenton | Florida | 34209 | United States |
| Gainesville | Florida | 32610-0214 | United States |
| Jacksonville | Florida | 32207 | United States |
| Wellington | Florida | 33414 | United States |
| Honolulu | Hawaii | 96817 | United States |
| Chicago | Illinois | 60612 | United States |
| Iowa City | Iowa | 52242 | United States |
| Boston | Massachusetts | 02111 | United States |
| St Louis | Missouri | 63104 | United States |
| Manhasset | New York | 11030 | United States |
| Chapel Hill | North Carolina | 27599-7584 | United States |
| Statesville | North Carolina | 28677 | United States |
| Cincinnati | Ohio | 45267-0595 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Houston | Texas | 77030 | United States |
| Salt Lake City | Utah | 84121 | United States |
| Charlottesville | Virginia | 22906-0013 | United States |
| Richmond | Virginia | 23249 | United States |
| Santurce | 00909 | Puerto Rico |
| FG001 |
| PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg |
Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks. |
| FG002 | PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg | Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks |
| FG003 | PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg | Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks. |
| Completed 24 Weeks of Follow-up |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The ITT [intent to treat] population which consisted of all participants who were randomized and received at least one dose of either of the study medication
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PEG-IFN Alfa-2a 180 mcg+ Ribavirin 1200 mg | Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks. |
| BG001 | PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg | Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks. |
| BG002 | PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg | Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks. |
| BG003 | PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg | Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks. |
| BG004 | 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 | HCV RNA Profile During The First 24 Weeks | Viral loads (quantitative HCV RNA) collected during the initial 24 weeks were first logarithmically (based 10) transformed. Results falling below the assay sensitivity level were set to the assay sensitivity level before the analyses. Thus, a qualitative HCV RNA negative result was set to 50 IU/mL (or 100 copies/mL). A qualitative HCV RNA positive result along with an unquantifiable HCV RNA result from the quantitative assay corresponded to a numeric HCV RNA result of 600 IU/mL (or 1000 copies/mL). | The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication. | Posted | Mean | Standard Deviation | log 10 copies/mL | Baseline (Day 1), At 72 hour (h), Week (W)-1, 2, 4, 12, 24 |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Virological Response | SVR is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/ml) at the end of the 24-week untreated follow-up period. | The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 72 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virological Response at the End of the Treatment Period | Virological response at the end of the treatment period is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/mL) at the completion of the treatment period. | The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 48 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virological Response At 12 Weeks After The End of The Treatment Period | Virological response at 12 weeks after the end of the treatment period is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/mL) at 12 weeks after completion of the treatment period. | The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 60 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events and Serious Adverse Events | An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. A serious adverse event is any adverse event (SAE) that can result in death or is Life-threatening or required in-patient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above. | The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment were included in the analysis. . | Posted | Number | percentage of participants | Up to Week 72 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Marked Laboratory Abnormalities | Marked laboratory abnormalities are the values outside the roche defined reference range.It is hemoglobin 11.0 - 20.0 (g/dL),platelets 100 - 700 (10^9/L), lymphocyte 1.00 - 6.30 (10^9/L),neutrophils 1.50 or more (10^9/L), white blood cells(WBC) 3.0 - 18.0 (10^9/L),serum glutamic-pyruvic transaminase (SGPT) 0 - 60 (U/L), serum glutamic oxaloacetic transaminase (SGOT) 0 - 50 (U/L), alkaline phosphatase 0 - 190 (U/L),albumin was 27.0 or more (g/L),gamma glutamyl transferases (GGT) 0 - 120 (U/L),Total protein 55 - 87 (g/L),total bilirubin 0 - 34.2 (μmol/L),BUN 0 - 14.3 (mmol/L),creatinine 0 - 154 (μmol/L),chloride 95 - 115 (mmol/L),potassium 3.0 - 6.0 (mmol/L), sodium 130 - 150 (mmol/L),thyroid stimulating hormone (TSH) 0.0 - 10.0 (mU/L),triglycerides 0.00 - 2.83 (mmol/L), calcium 2.00 - 2.90 (mmol/L),phosphate 0.75 - 1.60 (mmol/L),Blood Glucose 2.80 - 11.10 (mmol/L),Uric Acid 0 - 600 (μmol/L),proteinuria 0 - 1 (0 to 4+), glycosuria 0 - 1 (0 to 4+), hematuria 0 - 1 (0 to 4+). | The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment where included in the analysis. . | Posted | Number | percentage of participants | Up to Week 60 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Abnormal Vital Signs | Vital signs (Systolic blood pressure, Diastolic blood pressure, Pulse rate) were considered to be abnormal and of potential clinical relevance if the values measured for these parameters represented a change from baseline of greater than 20% in the direction of worsening. High diastolic blood pressure is defined as >110 mmhg and >20% increase from baseline. High systolic blood pressure is defined as >180 mmhg and >20% increase from baseline. Low systolic blood pressure is defined as <85 mmhg and >20% decrease from baseline. High heart rate is defined as >120 beats/minute and >20% increase from baseline. Low heart rate is defined as < 50 beats/minute and >20% decrease from baseline. | The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment were included in the analysis. . | Posted | Number | percentage of participants | Up to Week 72 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Total BDI-II (Beck Depression Inventory) Scores | The BDI-II is a self-reported assessment of 21 items which included sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, loss of interest in sex that are summarized by treatment group. All except two items had four statements that were scored on a scale ranging from 0 to 3. The maximum total score was 63. The scores for each item were summed to obtain the total for that assessment. The participants neurological status could then be categorized as follows: minimal depression: 0 to 13; mild depression: 14 to 19; moderate depression: 20 to 28; and severe depression: 29 to 63. The BDI-II questionnaire was self-administered by the patient at each visit. | The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment were included in the analysis. | Posted | Mean | Standard Deviation | Units on a scale | From Baseline (Day 1) to Week 72 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Virological Response Over Time to Week 24 | Virological response over time to Week 24 is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, V. 2.0 (detection limit = 50 IU/mL) at 72 hours and at weeks 1, 2, 12, and 24. | The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication. | Posted | Number | 95% Confidence Interval | percentage of participants | 72 hours post-dose, Weeks 1, 2, 4, 12, and 24 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Predicted Sustained Virological Response | The predicted sustained virological response (SVR) for each treatment group, is determined using a model based on the log10-transformed HCV viral load in copies/mL at Week 4 and the virological response status at Week 12. Each participant was classified as a predicted SVR if p was ≥ 0.5 or as a non-SVR if p was <0.5. The percentage was calculated from the number of participant (N) analyzed under "Distribution of the predicted probability of an SVR." | The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication. | Posted | Number | percentage of participants | Week 4 and 12 |
|
Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
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 180 mcg +Ribavirin 1200 mg | Participants received 180 mcg of PEG-IFN alfa-2a in 1-ml solution administered [subcutaneously] sc, once in a week + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks | 4 | 46 | 46 | 46 | ||
| EG001 | PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg | Participants received 180 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks. | 6 | 47 | 46 | 47 | ||
| EG002 | PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg | Participants received 270 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks | 6 | 47 | 47 | 47 | ||
| EG003 | PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg | Participants received 270 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks. | 5 | 47 | 47 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Staphylococcal Sepsis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Anaemia Haemolytic Autoimmune | Blood and lymphatic system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Homicidal Ideation | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA (8.0) | Systematic Assessment |
| |
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA (8.0) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | Systematic Assessment |
| |
| Non Hodgkin's Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | Systematic Assessment |
| |
| Retinal Vascular Disorder | Eye disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Haemorrhagic Ovarian Cyst | Reproductive system and breast disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (8.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Vertigio | Ear and labyrinth disorders | MedDRA (8.0) | Systematic Assessment |
| |
| 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 |
| |
| Constipation | 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 |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Chest discomfort | 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 |
| |
| Injection site rash | General disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Herpes Simplex | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Upper Respiratory tract infection | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (8.0) | Systematic Assessment |
| |
| Weight Decreased | Investigations | 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 |
| |
| Hypertriglyceridaemia | 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 |
| |
| Muscle spasm | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Myalgia | 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 |
| |
| Dysgeusia | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Anger | Psychiatric 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 |
| |
| Mood altered | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Sleep disorder | 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 |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Respiratory tract conjestion | 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 |
| |
| Night Sweats | 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 |
| |
| Rash Generalised | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Hypertension | Vascular 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 |
|
| At Hour 72, (n=41,41,42,46) |
|
| At Week 1, (n=44,47,45,46) |
|
| At Week 2, (n=43,45,43,46) |
|
| At Week 4, (n=44,45,44,46) |
|
| At Week 12, (n=45,45,41,44) |
|
| At Week 24, (n=42,45,40,37) |
|
| OG003 | PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg | Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks |
|
|
| OG003 | PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg | Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks |
|
|
| OG003 | PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg | Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks |
|
|
| OG001 |
| PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg |
Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks |
| OG002 | PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg | Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks |
| OG003 | PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg | Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks |
|
|
| OG001 | PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg | Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks. |
| OG002 | PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg | Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks |
| OG003 | PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg | Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks |
|
|
| OG002 | PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg | Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks |
| OG003 | PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg | Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks |
|
|
| OG001 |
| PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg |
Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks |
| OG002 | PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg | Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks |
| OG003 | PEG-IFN Alfa-2a 270 mcg+ Ribavirin 1600 mg | Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks |
|
|
| OG003 | PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg | Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks. |
|
|
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks |
| OG003 | PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg | Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks |
|
|