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This study will compare the efficacy and safety of treatment with pegylated-interferon alfa-2a plus ribavirin in participants with non-genotype 2/3 CHC who, after 12 weeks of study treatment, have undetectable hepatitis C virus (HCV)-ribonucleic acid (RNA) or a greater than or equal to (>=) 2 log10 drop in HCV-RNA. Participants will be randomized to receive pegylated-interferon alfa-2a 180 micrograms subcutaneously weekly plus ribavirin (1000-1400 milligram [mg]) orally daily for the specified duration, followed by 24 weeks of treatment-free follow-up. Participants with detectable HCV-RNA and less than (<) 2 log10 drop in HCV-RNA at week 12 will discontinue therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegylated-interferon Alfa-2a + Ribavirin (Group A) | Experimental | Participants with HCV RNA levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, will receive pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 milligrams (mg) orally daily for 48 weeks. |
|
| Pegylated-interferon Alfa-2a + Ribavirin (Group B) | Experimental | Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks. |
|
| Pegylated-interferon Alfa-2a + Ribavirin (Group C) | Experimental | Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks. |
|
| Pegylated-interferon Alfa-2a + Ribavirin (Group D) | Experimental | Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated-interferon Alfa-2a | Drug | Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virological Response (SVR) (Groups A and B) | SVR was defined as success if the participant had HCV RNA levels <15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups A and B was reported in this analysis. | At 24-week untreated follow-up visit (up to 72 weeks for Group A, up to 96 weeks for Group B) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With SVR (Groups C, D, E, and F) | SVR was defined as success if the participant had HCV RNA levels <15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups C, D, E, and F was reported in this 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 |
|---|---|---|---|---|---|---|
| Milwaukee | Wisconsin | 53210 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22050141 | Derived | Lee SS, Sherman M, Ramji A, Greenbloom S, Elkashab M, Pluta H, Hilzenrat N, Balshaw R, Usaty C, Myers RP. Randomised clinical trial: the efficacy of treatment, guided by a shorter duration of response, using peginterferon alfa-2a plus ribavirin for hepatitis C virus other than genotypes 2 or 3. Aliment Pharmacol Ther. 2012 Jan;35(1):37-47. doi: 10.1111/j.1365-2036.2011.04911.x. Epub 2011 Nov 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pegylated-interferon Alfa-2a + Ribavirin (Group A) | Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Pegylated-interferon Alfa-2a + Ribavirin (Group E) | Experimental | Participants with HCV-RNA levels <15 IU/mL at Week 4, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks. |
|
| Pegylated-interferon Alfa-2a + Ribavirin (Group F) | Experimental | Participants with HCV-RNA levels <15 IU/mL at Week 4, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks. |
|
| Pegylated-interferon Alfa-2a + Ribavirin (Group NR) | Experimental | Participants who do not have any change in HCV-RNA levels at Weeks 4, 8, and 12 will not be randomized (NR) to any of the other groups. Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks. |
|
|
| Ribavirin | Drug | Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration. |
|
|
| At 24-week untreated follow-up visit (up to 60, 72, 48, and 72 weeks for Groups C, D, E, and F, respectively) |
| Percentage of Participants With Virological Responses (Groups A, B, C, D, E, and F) | End of treatment response (ETR) was defined as "Success" if the HCV-RNA levels were <15 IU/mL at the end of treatment. Early virological response (EVR) was defined as >=2 log10 decrease in serum HCV RNA or undetectable serum HCV RNA (<15 IU/mL) at Week 12. Complete EVR was defined as "Success", if the HCV-RNA levels were <15 IU/mL at Week 12. Partial EVR was defined as "Success", if there was a >=2 log10 drop in HCV-RNA at Week 12 compared to baseline but with a level that was still >=15 IU/mL at that time point. | Week 12 (Groups C, D, E, and F), and end of treatment (Weeks 48, 72, 36, 48, 24, and 48 for Groups A, B, C, D, E, and F, respectively) |
| Calgary |
| Alberta |
| T2N 4Z6 |
| Canada |
| Edmonton | Alberta | T5H 4B9 | Canada |
| Edmonton | Alberta | T6G 2X8 | Canada |
| Abbotsford British Columbia | British Columbia | V2S 3N5 | Canada |
| Vancouver | British Columbia | V5Z 1M9 | Canada |
| Vancouver | British Columbia | V6Z 2K5 | Canada |
| Vernon | British Columbia | V1T 1W9 | Canada |
| Victoria | British Columbia | V8V 3P9 | Canada |
| Halifax | Nova Scotia | B3H 2Y9 | Canada |
| East York | Ontario | M4C 3E7 | Canada |
| Hamilton | Ontario | L8L 2X2 | Canada |
| Kingston | Ontario | K7L 5G2 | Canada |
| London | Ontario | N6A 5A5 | Canada |
| Mississauga | Ontario | L5M 4N4 | Canada |
| Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto | Ontario | M5G 1L7 | Canada |
| Toronto | Ontario | M5G 1X5 | Canada |
| Toronto | Ontario | M6H 3M1 | Canada |
| Woodbridge | Ontario | L4L 4Y7 | Canada |
| Montreal | Quebec | H1T 2M4 | Canada |
| Montreal | Quebec | H3A 1A1 | Canada |
| Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| FG001 | Pegylated-interferon Alfa-2a + Ribavirin (Group B) | Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks. |
| FG002 | Pegylated-interferon Alfa-2a + Ribavirin (Group C) | Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks. |
| FG003 | Pegylated-interferon Alfa-2a + Ribavirin (Group D) | Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks. |
| FG004 | Pegylated-interferon Alfa-2a + Ribavirin (Group E) | Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks. |
| FG005 | Pegylated-interferon Alfa-2a + Ribavirin (Group F) | Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks. |
| FG006 | Pegylated-interferon Alfa-2a + Ribavirin (Group NR) | Participants who did not have any change in HCV-RNA levels at Weeks 4, 8, and 12 were not randomized (NR) to any of the other groups. Participants received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks. |
| COMPLETED |
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| NOT COMPLETED |
|
|
The safety (SAF) population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pegylated-interferon Alfa-2a + Ribavirin (Group A) | Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks. |
| BG001 | Pegylated-interferon Alfa-2a + Ribavirin (Group B) | Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks. |
| BG002 | Pegylated-interferon Alfa-2a + Ribavirin (Group C) | Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks. |
| BG003 | Pegylated-interferon Alfa-2a + Ribavirin (Group D) | Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks. |
| BG004 | Pegylated-interferon Alfa-2a + Ribavirin (Group E) | Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks. |
| BG005 | Pegylated-interferon Alfa-2a + Ribavirin (Group F) | Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks. |
| BG006 | Pegylated-interferon Alfa-2a + Ribavirin (Group NR) | Participants who did not have any change in HCV-RNA levels at Weeks 4, 8, and 12 were not randomized (NR) to any of the other groups. Participants received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks. |
| BG007 | 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 |
| |||||||||||||||
| Gender | 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) (Groups A and B) | SVR was defined as success if the participant had HCV RNA levels <15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups A and B was reported in this analysis. | Intent-to-treat (ITT) population included randomized participants who received at least one dose of study medication and who had a baseline HCV-RNA which was at least 15 IU/mL. Here, "Number of Participants Analyzed" = the participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | At 24-week untreated follow-up visit (up to 72 weeks for Group A, up to 96 weeks for Group B) |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With SVR (Groups C, D, E, and F) | SVR was defined as success if the participant had HCV RNA levels <15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups C, D, E, and F was reported in this analysis. | ITT. Here, "Number of Participants Analyzed" = the participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | At 24-week untreated follow-up visit (up to 60, 72, 48, and 72 weeks for Groups C, D, E, and F, respectively) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virological Responses (Groups A, B, C, D, E, and F) | End of treatment response (ETR) was defined as "Success" if the HCV-RNA levels were <15 IU/mL at the end of treatment. Early virological response (EVR) was defined as >=2 log10 decrease in serum HCV RNA or undetectable serum HCV RNA (<15 IU/mL) at Week 12. Complete EVR was defined as "Success", if the HCV-RNA levels were <15 IU/mL at Week 12. Partial EVR was defined as "Success", if there was a >=2 log10 drop in HCV-RNA at Week 12 compared to baseline but with a level that was still >=15 IU/mL at that time point. | ITT population | Posted | Number | percentage of participants | Week 12 (Groups C, D, E, and F), and end of treatment (Weeks 48, 72, 36, 48, 24, and 48 for Groups A, B, C, D, E, and F, respectively) |
|
Baseline up to 96 weeks
Safety population
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 | Pegylated-interferon Alfa-2a + Ribavirin (Group A) | Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks. | 4 | 41 | 39 | 41 | ||
| EG001 | Pegylated-interferon Alfa-2a + Ribavirin (Group B) | Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks. | 6 | 43 | 43 | 43 | ||
| EG002 | Pegylated-interferon Alfa-2a + Ribavirin (Group C) | Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks. | 5 | 30 | 30 | 30 | ||
| EG003 | Pegylated-interferon Alfa-2a + Ribavirin (Group D) | Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks. | 4 | 31 | 31 | 31 | ||
| EG004 | Pegylated-interferon Alfa-2a + Ribavirin (Group E) | Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks. | 0 | 25 | 25 | 25 | ||
| EG005 | Pegylated-interferon Alfa-2a + Ribavirin (Group F) | Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks. | 4 | 26 | 25 | 26 | ||
| EG006 | Pegylated-interferon Alfa-2a + Ribavirin (Group NR) | Participants who did not have any change in HCV-RNA levels at Weeks 4, 8, and 12 were not randomized (NR) to any of the other groups. Participants received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks. | 3 | 40 | 35 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Caecitis | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Multiple drug overdose | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Emotional/mental (depression, anxiety, irritability, forgetfulness, confusion, anger) | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment | This was reported as 'adverse event (AE) cluster' i.e. combination of multiple AEs and not as separate AE preferred terms (PTs). |
|
| Suicide attempt | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pregnancy of partner | Social circumstances | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Gastrointestinal symptoms (diarrhea, bloating, gas) | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment | This was reported as 'AE cluster' i.e. combination of multiple AEs and not as separate AE PTs. |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Flu-like symptoms (fever, chills, headache, aches/pains) | General disorders | MedDRA Version 13.0 | Non-systematic Assessment | This was reported as 'AE cluster' i.e. combination of multiple AEs and not as separate AE PTs. |
|
| Ear infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Emotional/mental (depression, anxiety, irritability, forgetfulness, confusion, anger) | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment | This was reported as 'AE cluster' i.e. combination of multiple AEs and not as separate AE PTs. |
|
| Insomnia | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Skin (injection site reactions, rashes, pruritus) | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment | This was reported as 'AE cluster' i.e. combination of multiple AEs and not as separate AE PTs. |
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| Hot flush | Vascular disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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
| Male |
|
| OG002 |
| Pegylated-interferon Alfa-2a + Ribavirin (Group E) |
Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks. |
| OG003 | Pegylated-interferon Alfa-2a + Ribavirin (Group F) | Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks. |
|
|
|
| OG002 | Pegylated-interferon Alfa-2a + Ribavirin (Group C) | Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks. |
| OG003 | Pegylated-interferon Alfa-2a + Ribavirin (Group D) | Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks. |
| OG004 | Pegylated-interferon Alfa-2a + Ribavirin (Group E) | Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks. |
| OG005 | Pegylated-interferon Alfa-2a + Ribavirin (Group F) | Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks. |
|
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