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This 2-arm study will compare the efficacy and safety of treatment with Pegasys (180 µg weekly) plus Copegus (800 mg daily) and Pegasys (180 µg weekly) plus Copegus (1000-1200 mg daily) in interferon-naive patients with CHC genotype 1 co-infected with HIV-1. Treatment will be administered for 48 weeks, and this will be followed by 24 treatment-free weeks. 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 800 mg | Experimental |
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| PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2a | Drug | 180 µg subcutaneously weekly for 48 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Sustained Virological Response (SVR) | SVR was defined by the percentage of patients with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of the 48-week treatment period (i.e., a single last HCV RNA < 20 IU/mL measured ≥ Day 477 [≥ Week 68]). Patients without an HCV measurement at the end of the 24-week untreated follow-up period were considered nonresponders. | Week 72 |
| Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia | Adverse events of anemia included hemolytic anemia, aplasia pure red cell, and pancytopenia. | Up to Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Virological Response at End of Treatment Period | Virological response at the end of the treatment period was defined as a single last HCV RNA measurement <20 IU/mL at the completion of the treatment period (Days 324 to 351). Patients without an HCV measurement at Week 48 were considered nonresponders. | Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22592094 | Derived | Rodriguez-Torres M, Slim J, Bhatti L, Sterling R, Sulkowski M, Hassanein T, Serrao R, Sola R, Bertasso A, Passe And S, Stancic S. Peginterferon alfa-2a plus ribavirin for HIV-HCV genotype 1 coinfected patients: a randomized international trial. HIV Clin Trials. 2012 May-Jun;13(3):142-52. doi: 10.1310/hct1303-142. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg | |
| FG001 | PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Ribavirin | Drug | 800 mg orally daily for 48 weeks |
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| Ribavirin | Drug | 1000 mg or 1200 mg (based on patient weight of < 75 kg or ≥ 75 kg, respectively) orally daily for 48 weeks |
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| Virological Response at Weeks 4, 12 and 24 |
Virological response at Weeks 4, 12 and 24 was also defined as a single last undetectable HCV RNA (< 20 IU/mL) falling within the visit windows of Days 16 to 43, 72 to 99, and 156 to 183, respectively. Patients without an HCV measurement at a study week were considered nonresponders at that study week. |
| Weeks 4, 12 and 24 |
| Relapse of Virological Response | Relapse of virological response was calculated by dividing the number of patients who achieved a virological response at the end of treatment but had detectable HCV RNA at the last assessment posttreatment by the number of patients with a virological response at the end of treatment who had at least one HCV RNA assessment posttreatment. | Weeks 48 and 72 |
| Rapid Virological Response (RVR) by Week 4 | RVR was defined as an undetectable HCV RNA < 20 IU/mL (a single last HCV RNA < 20 IU/mL falling in the time window of Days 2 to 43). Patients without an HCV measurement by Week 4 were considered nonresponders. | Week 4 |
| Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12 | EVR: Undetectable HCV RNA <20 IU/mL or ≥2 log10 drop from pretreatment level, by Week 12 (a single last HCV RNA <20 IU/mL or ≥2 log10 drop from pretreatment level in the time window of Days 2 to 99). Partial EVR: Detectable HCV RNA but ≥2 log10 drop from pretreatment, by Week 12 (a single last HCV RNA detectable but ≥2 log10 drop from pretreatment in the time window of Days 2 to 99). Complete EVR: Undetectable HCV RNA <20 IU/mL, by Week 12 (a single last HCV RNA <20 IU/mL in the time window of Days 2 to 99). Patients without an HCV measurement by Week 12 were considered nonresponders. | Week 12 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg | |
| BG001 | PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients. | Number | Participants |
| ||||||||||||||||||
| Age Continuous | The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients. | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Gender | The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients. | Number | Participants |
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| 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 | Sustained Virological Response (SVR) | SVR was defined by the percentage of patients with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of the 48-week treatment period (i.e., a single last HCV RNA < 20 IU/mL measured ≥ Day 477 [≥ Week 68]). Patients without an HCV measurement at the end of the 24-week untreated follow-up period were considered nonresponders. | The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients. | Posted | Number | Percentage of participants | Week 72 |
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| Secondary | Virological Response at End of Treatment Period | Virological response at the end of the treatment period was defined as a single last HCV RNA measurement <20 IU/mL at the completion of the treatment period (Days 324 to 351). Patients without an HCV measurement at Week 48 were considered nonresponders. | The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients. | Posted | Number | Percentage of participants | Week 48 |
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| Secondary | Virological Response at Weeks 4, 12 and 24 | Virological response at Weeks 4, 12 and 24 was also defined as a single last undetectable HCV RNA (< 20 IU/mL) falling within the visit windows of Days 16 to 43, 72 to 99, and 156 to 183, respectively. Patients without an HCV measurement at a study week were considered nonresponders at that study week. | The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients. | Posted | Number | Percentage of participants | Weeks 4, 12 and 24 |
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| Secondary | Relapse of Virological Response | Relapse of virological response was calculated by dividing the number of patients who achieved a virological response at the end of treatment but had detectable HCV RNA at the last assessment posttreatment by the number of patients with a virological response at the end of treatment who had at least one HCV RNA assessment posttreatment. | Within the All Patients Treated population, patients with a response at end of treatment: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 37 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 83 patients. | Posted | Number | Percentage of participants | Weeks 48 and 72 |
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| Secondary | Rapid Virological Response (RVR) by Week 4 | RVR was defined as an undetectable HCV RNA < 20 IU/mL (a single last HCV RNA < 20 IU/mL falling in the time window of Days 2 to 43). Patients without an HCV measurement by Week 4 were considered nonresponders. | The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients. | Posted | Number | Percentage of participants | Week 4 |
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| Secondary | Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12 | EVR: Undetectable HCV RNA <20 IU/mL or ≥2 log10 drop from pretreatment level, by Week 12 (a single last HCV RNA <20 IU/mL or ≥2 log10 drop from pretreatment level in the time window of Days 2 to 99). Partial EVR: Detectable HCV RNA but ≥2 log10 drop from pretreatment, by Week 12 (a single last HCV RNA detectable but ≥2 log10 drop from pretreatment in the time window of Days 2 to 99). Complete EVR: Undetectable HCV RNA <20 IU/mL, by Week 12 (a single last HCV RNA <20 IU/mL in the time window of Days 2 to 99). Patients without an HCV measurement by Week 12 were considered nonresponders. | The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients. | Posted | Number | Percentage of participants | Week 12 |
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| Primary | Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia | Adverse events of anemia included hemolytic anemia, aplasia pure red cell, and pancytopenia. | The Safety population included all patients randomized who received at least one dose of the study medication and had at least one postbaseline safety assessment: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 274 patients. | Posted | Number | Percentage of participants | Up to Week 72 |
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The Safety population included all patients randomized who received at least one dose of the study medication and had at least one postbaseline safety assessment: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 274 patients.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg | 21 | 135 | 132 | 135 | |||
| EG001 | PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg | 46 | 274 | 264 | 274 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations |
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| Cellulitis | Infections and infestations |
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| Pneumonia | Infections and infestations |
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| Pneumonia Pneumococcal | Infections and infestations |
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| Staphylococcal Abscess | Infections and infestations |
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| Urinary Tract Infection | Infections and infestations |
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| Anal Abscess | Infections and infestations |
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| Bursitis Infective | Infections and infestations |
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| Carbuncle | Infections and infestations |
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| Gangrene | Infections and infestations |
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| Gastroenteritis | Infections and infestations |
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| Gastroenteritis Viral | Infections and infestations |
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| Herpes Zoster | Infections and infestations |
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| Infected Skin Ulcer | Infections and infestations |
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| Influenza | Infections and infestations |
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| Pneumococcal Bacteraemia | Infections and infestations |
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| Sepsis | Infections and infestations |
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| Subcutaneous Abscess | Infections and infestations |
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| Subdiaphragmatic Abscess | Infections and infestations |
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| Wound Infection | Infections and infestations |
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| Anaemia | Blood and lymphatic system disorders |
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| Haemolytic Anaemia | Blood and lymphatic system disorders |
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| Thrombocytopenia | Blood and lymphatic system disorders |
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| Autoimmune Thrombocytopenia | Blood and lymphatic system disorders |
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| Pancytopenia | Blood and lymphatic system disorders |
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| Vomiting | Gastrointestinal disorders |
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| Abdominal Pain | Gastrointestinal disorders |
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| Colitis | Gastrointestinal disorders |
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| Constipation | Gastrointestinal disorders |
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| Oesophageal Varices Haemorrhage | Gastrointestinal disorders |
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| Pancreatitis | Gastrointestinal disorders |
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| Small Intestinal Obstruction | Gastrointestinal disorders |
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| Depression | Psychiatric disorders |
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| Completed Suicide | Psychiatric disorders |
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| Substance Abuse | Psychiatric disorders |
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| Suicidal Ideation | Psychiatric disorders |
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| Suicide Attempt | Psychiatric disorders |
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| Abnormal Loss of Weight | Metabolism and nutrition disorders |
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| Dehydration | Metabolism and nutrition disorders |
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| Hyperglycaemia | Metabolism and nutrition disorders |
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| Hyponatraemia | Metabolism and nutrition disorders |
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| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders |
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| Asthma | Respiratory, thoracic and mediastinal disorders |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders |
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| Acute Myocardial Infarction | Cardiac disorders |
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| Atrial Fibrillation | Cardiac disorders |
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| Hypertrophic Cardiomyopathy | Cardiac disorders |
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| Myocardial Infarction | Cardiac disorders |
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| Pericarditis | Cardiac disorders |
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| Accidental Overdose | Injury, poisoning and procedural complications |
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| Ankle Fracture | Injury, poisoning and procedural complications |
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| Multiple Injuries | Injury, poisoning and procedural complications |
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| Splenic Injury | Injury, poisoning and procedural complications |
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| Benign Lung Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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| Hepatic Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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| Lung Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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| Brain Stem Ischaemia | Nervous system disorders |
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| Convulsion | Nervous system disorders |
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| Optic Neuritis | Nervous system disorders |
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| Cholecystitis Acute | Hepatobiliary disorders |
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| Cholelithiasis | Hepatobiliary disorders |
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| Epididymitis | Reproductive system and breast disorders |
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| Prostatitis | Reproductive system and breast disorders |
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| Retinal Detachment | Eye disorders |
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| Pyrexia | General disorders |
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| Orthostatic Hypotension | Vascular disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders |
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| Pyrexia | General disorders |
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| Chills | General disorders |
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| Irritability | General disorders |
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| Pain | General disorders |
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| Asthenia | General disorders |
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| Malaise | General disorders |
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| Nausea | Gastrointestinal disorders |
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| Diarrhoea | Gastrointestinal disorders |
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| Vomiting | Gastrointestinal disorders |
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| Abdominal Pain | Gastrointestinal disorders |
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| Dyspepsia | Gastrointestinal disorders |
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| Constipation | Gastrointestinal disorders |
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| Insomnia | Psychiatric disorders |
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| Anxiety | Psychiatric disorders |
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| Headache | Nervous system disorders |
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| Dizziness | Nervous system disorders |
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| Upper Respiratory Tract Infection | Infections and infestations |
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| Urinary Tract Infection | Infections and infestations |
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| Bronchitis | Infections and infestations |
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| Anaemia | Blood and lymphatic system disorders |
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| Neutropenia | Blood and lymphatic system disorders |
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| Myalgia | Musculoskeletal and connective tissue disorders |
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| Arthralgia | Musculoskeletal and connective tissue disorders |
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| Back Pain | Musculoskeletal and connective tissue disorders |
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| Muscle Spasms | Musculoskeletal and connective tissue disorders |
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| Rash | Skin and subcutaneous tissue disorders |
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| Alopecia | Skin and subcutaneous tissue disorders |
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| Dry Skin | Skin and subcutaneous tissue disorders |
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| Pruritus | Skin and subcutaneous tissue disorders |
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| Night Sweats | Skin and subcutaneous tissue disorders |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders |
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| Cough | Respiratory, thoracic and mediastinal disorders |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders |
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| Decreased Appetite | Metabolism and nutrition disorders |
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| Weight Decreased | Investigations |
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| Depression | Psychiatric disorders |
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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 |
| 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 |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Title | Measurements |
|---|---|
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| Male |
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