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This study will evaluate the addition of a higher-dose induction treatment period with peginterferon (PEG-IFN) alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with PEG-IFN alfa-2a and ribavirin, compared to standard-dose treatment, in treatment-naive participants with CHC, genotype 1 infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-IFN alfa-2a+Ribavirin - Induction Treatment | Experimental | Participants will receive 12 weeks of induction therapy with PEG-IFN alfa-2a (Pegasys), 360 micrograms (mcg) subcutaneous (SC) once weekly, along with ribavirin, 1000 or 1200 milligrams (mg) orally daily in divided doses. Thereafter, the dose of PEG-IFN alfa-2a will be reduced to 180 mcg SC once weekly and the ribavirin dose maintained for the remaining 36 weeks of treatment. |
|
| PEG-IFN alfa-2a+Ribavirin - Standard Treatment | Experimental | Participants will receive 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-IFN alfa-2a | Drug | PEG-IFN alfa-2a will be administered once weekly for 48 weeks, at doses specified in respective arms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virological Response According to Scheduled Treatment Period | Sustained virological response was calculated as the percentage of participants with undetectable (less than [<] 15 international units per milliliter [IU/mL]) hepatitis C virus (HCV) ribonucleic acid (RNA) as measured by the Roche TaqMan HCV Test 24 weeks after completion of the scheduled 48-week treatment period. | Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With End-of-Treatment Virological Response According to Scheduled Treatment Period | Virological response at the end of the scheduled treatment period was defined as the percentage of participants with undetectable (<15 IU/mL) HCV RNA as measured by the Roche TaqMan HCV Test at Week 48. | Weeks 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buenos Aires | 1640 | Argentina | ||||
Not provided
Out of total 896 randomized participants, 25 participants (15 in the induction group and 10 in the standard group) did not receive study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | PEG-IFN Alfa-2a+Ribavirin - Induction Treatment | Participants received 12 weeks of induction therapy with peginterferon (PEG-IFN) alfa-2a (Pegasys), 360 micrograms (mcg) subcutaneous (SC) once weekly, along with ribavirin, 1000 or 1200 milligrams (mg) orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Ribavirin | Drug | Ribavirin 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight, for 48 weeks. |
|
|
| Percentage of Participants With Virological Responses Over Time |
Virological response was defined as undetectable HCV RNA (<15 IU/mL) as measured by the Roche TaqMan HCV Test. Participants without HCV RNA measurements at a study week are considered non responders at that study week. |
| Weeks 4, 8, 12, and 24 |
| Percentage of Participants With Relapse of End-of-treatment Virological Response | Relapse was determined based on virological response at the actual end of treatment and was calculated by dividing the number of participants who achieved a virological response at end of treatment but later had detectable HCV RNA at the last assessment post-treatment by the number of participants with a virological response at end of treatment, defined as undetectable HCV RNA (<15 IU/mL). Participants who achieved a virological response at end of treatment but did not have any HCV RNA assessment during follow-up were excluded and were not considered as having relapsed. However, if no assessment was available within the end of-treatment time window but the participant had a sustained virological response according to the actual treatment period, backward imputation was used and the participant was considered to have achieved an end-of-treatment virological response in the analysis. | Actual end of treatment (Week 48) up to last follow up (maximum up to Week 72) |
| Percentage of Participants With Predictive Values of Virological Response for Sustained Virological Response | The ability of virological responses to predict sustained virological response according to the scheduled treatment periods was assessed in terms of positive predictive value (PPV) and negative predictive value (NPV). The PPV indicates probability of achievement of viral suppression (undetectable HCV RNA) for achieving a sustained virological response and the NPV indicates probability of not achieving viral suppression for not achieving a sustained virological response. The PPV at Week 4 or 12 was calculated as the number of participants who achieved viral suppression both at Week 4 or 12 and at Week 72 divided by the number of participants who achieved viral suppression at Week 4 or 12, multiplied by 100. The NPV at Week 4 or 12 was calculated as the number of participants who failed to achieve viral suppression at Week 4 or 12 and at Week 72 divided by the number of participants who failed to achieve viral suppression at Week 4 or 12, multiplied by 100. | Weeks 4, 12, and 72 |
| Change From Baseline in Log10 HCV RNA Values | The mean decrease in log10 HCV RNA levels from baseline was assessed in both the induction group and the standard group. | Baseline, Weeks 4, 8, 12, 24, and at end of treatment (EoT) (maximum up to Week 48) |
| Buenos Aires |
| C1282AFE |
| Argentina |
| La Plata | B1902AVF | Argentina |
| Rosario | 2000 | Argentina |
| Adelaide | 5000 | Australia |
| Adelaide | 5042 | Australia |
| Bankstown | 2200 | Australia |
| Box Hill | 3128 | Australia |
| Brisbane | 4029 | Australia |
| Cottontree | 4558 | Australia |
| Darlinghurst | 2010 | Australia |
| Douglas | Australia |
| Fitzroy | 3065 | Australia |
| Fremantle | 6160 | Australia |
| Geelong | 3220 | Australia |
| Greenslopes | 4120 | Australia |
| Kingswood | Australia |
| Lismore | 2480 | Australia |
| Liverpool | 1871 | Australia |
| Liverpool | 2170 | Australia |
| Melbourne | 3011 | Australia |
| Melbourne | 3084 | Australia |
| Melbourne | 3181 | Australia |
| Melbourne | 3186 | Australia |
| Miranda | 2228 | Australia |
| Nedlands | 6009 | Australia |
| New Lambton Heights | 2310 | Australia |
| Parkville | 3052 | Australia |
| Perth | 6001 | Australia |
| Sydney | 2010 | Australia |
| Sydney | 2050 | Australia |
| Sydney | 2139 | Australia |
| Sydney | 2145 | Australia |
| Victoria | 3199 | Australia |
| Woden | 2606 | Australia |
| Wollongong | 2500 | Australia |
| Woolloongabba | 4102 | Australia |
| Calgary | Alberta | T2N 4N1 | Canada |
| Edmonton | Alberta | T5H 4B9 | Canada |
| Vancouver | British Columbia | V5Z 1M9 | Canada |
| Mississauga | Ontario | L5M 2V8 | Canada |
| Montreal | Quebec | H3T 1E2 | Canada |
| Guadalajara | 44280 | Mexico |
| Guadalajara | 44650 | Mexico |
| Monterrey | 64460 | Mexico |
| Auckland | 100 | New Zealand |
| Hamilton | New Zealand |
| Riccarton, Christchurch | 8011 | New Zealand |
| Bangkok | 10400 | Thailand |
| Bangkok | 10700 | Thailand |
| Chiang Mai | 50202 | Thailand |
| FG001 | PEG-IFN Alfa-2a+Ribavirin - Standard Treatment | Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) analysis population included all randomized participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PEG-IFN Alfa-2a+Ribavirin - Induction Treatment | Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment. |
| BG001 | PEG-IFN Alfa-2a+Ribavirin - Standard Treatment | Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Sustained Virological Response According to Scheduled Treatment Period | Sustained virological response was calculated as the percentage of participants with undetectable (less than [<] 15 international units per milliliter [IU/mL]) hepatitis C virus (HCV) ribonucleic acid (RNA) as measured by the Roche TaqMan HCV Test 24 weeks after completion of the scheduled 48-week treatment period. | ITT analysis population | Posted | Number | percentage of participants | Week 72 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With End-of-Treatment Virological Response According to Scheduled Treatment Period | Virological response at the end of the scheduled treatment period was defined as the percentage of participants with undetectable (<15 IU/mL) HCV RNA as measured by the Roche TaqMan HCV Test at Week 48. | ITT analysis population | Posted | Number | percentage of participants | Weeks 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virological Responses Over Time | Virological response was defined as undetectable HCV RNA (<15 IU/mL) as measured by the Roche TaqMan HCV Test. Participants without HCV RNA measurements at a study week are considered non responders at that study week. | ITT analysis population | Posted | Number | percentage of participants | Weeks 4, 8, 12, and 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Relapse of End-of-treatment Virological Response | Relapse was determined based on virological response at the actual end of treatment and was calculated by dividing the number of participants who achieved a virological response at end of treatment but later had detectable HCV RNA at the last assessment post-treatment by the number of participants with a virological response at end of treatment, defined as undetectable HCV RNA (<15 IU/mL). Participants who achieved a virological response at end of treatment but did not have any HCV RNA assessment during follow-up were excluded and were not considered as having relapsed. However, if no assessment was available within the end of-treatment time window but the participant had a sustained virological response according to the actual treatment period, backward imputation was used and the participant was considered to have achieved an end-of-treatment virological response in the analysis. | ITT analysis population. Here, number of participants analyzed signifies participants who had end of treatment virologic response and had HCV RNA measurement available during follow-up. | Posted | Number | percentage of participants | Actual end of treatment (Week 48) up to last follow up (maximum up to Week 72) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Predictive Values of Virological Response for Sustained Virological Response | The ability of virological responses to predict sustained virological response according to the scheduled treatment periods was assessed in terms of positive predictive value (PPV) and negative predictive value (NPV). The PPV indicates probability of achievement of viral suppression (undetectable HCV RNA) for achieving a sustained virological response and the NPV indicates probability of not achieving viral suppression for not achieving a sustained virological response. The PPV at Week 4 or 12 was calculated as the number of participants who achieved viral suppression both at Week 4 or 12 and at Week 72 divided by the number of participants who achieved viral suppression at Week 4 or 12, multiplied by 100. The NPV at Week 4 or 12 was calculated as the number of participants who failed to achieve viral suppression at Week 4 or 12 and at Week 72 divided by the number of participants who failed to achieve viral suppression at Week 4 or 12, multiplied by 100. | ITT analysis population; participants who did not have an HCV RNA measurement at Week 4 or 12 and at Week 72 were excluded from the analysis. Here, number of participants analyzed = number of participants evaluable for this outcome measure; 'n' = number of participants analyzed at specified time point for reported group, respectively. | Posted | Number | percentage of participants | Weeks 4, 12, and 72 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Log10 HCV RNA Values | The mean decrease in log10 HCV RNA levels from baseline was assessed in both the induction group and the standard group. | ITT analysis population; Here, number of participants analyzed = number of participants evaluable for this outcome measure; 'n' = number of participants analyzed at specified time point for reported group, respectively. | Posted | Mean | Standard Deviation | Log 10 IU/mL | Baseline, Weeks 4, 8, 12, 24, and at end of treatment (EoT) (maximum up to Week 48) |
|
Baseline up to Week 72
Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
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+Ribavirin - Induction Treatment | Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment. | 46 | 433 | 428 | 433 | ||
| EG001 | PEG-IFN Alfa-2a+Ribavirin - Standard Treatment | Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. | 45 | 438 | 430 | 438 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Bartholin's abscess | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Abdominal strangulated hernia | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Erosive duodenitis | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Gastric stenosis | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Varices oesophageal | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Delirium tremens | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Depression suicidal | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Accident | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Foreign body trauma | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Spinal cord injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pharyngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pulmonary granuloma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pulmonary sarcoidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Autoimmune thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
| |
| Bartholin's cyst | Reproductive system and breast disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Epididymal cyst | Reproductive system and breast disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Optic Ischaemic Neuropathy | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Heart rate irregular | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hypotonic urinary bladder | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Finger amputation | Surgical and medical procedures | MedDRA 11.0 | Non-systematic Assessment |
| |
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Mood swings | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-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 | |
|---|---|---|---|---|
| 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 |
|
| Participants |
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| OG001 | PEG-IFN Alfa-2a+Ribavirin - Standard Treatment | Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. |
|
|
| OG001 | PEG-IFN Alfa-2a+Ribavirin - Standard Treatment | Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. |
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| Units |
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| Counts |
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| Participants |
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