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| ID | Type | Description | Link |
|---|---|---|---|
| 001/05 |
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The objective of the study is to evaluate, in each group, the number of participants who achieve rapid virological response (RVR) after 4 weeks treatment with PegIntron and Rebetol. The study will also assess whether RVR is a reliable predictor of sustained virologic response (defined as undetectable viral load at 24 weeks post-treatment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mono-infected with HCV | Participants infected with Hepatitis C Virus (HCV). |
| |
| Co-infected with HCV and HIV | Participants co-infected with HCV and Human Immunodeficiency Virus (HIV). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PegIntron (peginterferon alfa-2b; SCH 54031) | Biological | PegIntron administered in accordance with approved labeling |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment | Rapid virologic response (RVR) was defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) negative after 4 weeks of treatment. | Assessed at Treatment Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved Sustained Virologic Response (SVR) | SVR was defined as non-detectable HCV RNA 24 weeks post-treatment. | Assessed at 24 weeks post-treatment |
| Number of Participants With RVR Who Also Achieved SVR |
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Inclusion Criteria:
Exclusion Criteria:
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Participants infected with Hepatitis C Virus (HCV) who are undergoing treatment with PegIntron and Rebetol in accordance with approved labeling at approximately 60 sites in Brazil. Participants could be treatment-naïve, undergoing re-treatment, or co-infected with Human Immunodeficiency Virus (HIV).
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21871496 | Result | Santos C, Reis A, Dos Santos CV, Damas C, Silva MH, Viana MV, Ferraz ML, Carnauba D, El-Far F, Serra F, Diaz RS. The use of real-time PCR to detect hepatitis C virus RNA in dried blood spots from Brazilian patients infected chronically. J Virol Methods. 2012 Jan;179(1):17-20. doi: 10.1016/j.jviromet.2011.06.012. Epub 2011 Jun 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mono-infected With HCV | Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling. |
| FG001 | Co-infected With HCV and HIV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Rebetol (ribavirin; SCH 18908) | Drug | Rebetol administered in accordance with approved labeling |
|
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RVR was defined as HCV RNA negative after 4 weeks of treatment. SVR was defined as non-detectable HCV RNA 24 weeks or more post-treatment.
| Assessed at Treatment Week 4 (RVR) and 24 weeks post-treatment (SVR) |
| Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR | Participants who achieved RVR at Treatment Week 4 who were considered to have SVR (non-detectable HCV RNA at Treatment Week 48 for genotypes 2 and 3, and Treatment Week 72 for genotypes 1, 4, and 5). Participants from the Mono-infected with HCV group and the Co-infected with HCV and HIV group, were identified as either Genotype 1, 2, 3, 4, or 5. | Treatment Week 48 and Treatment Week 72 |
| Assessment of Baseline Characteristics in Participants With SVR | Baseline characteristics assessed were age, gender, and genotype. | 24 Weeks post-treatment |
Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mono-infected With HCV | Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling. |
| BG001 | Co-infected With HCV and HIV | Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling. |
| 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 | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | 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 | Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment | Rapid virologic response (RVR) was defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) negative after 4 weeks of treatment. | Posted | Number | Participants | Assessed at Treatment Week 4 |
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| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Achieved Sustained Virologic Response (SVR) | SVR was defined as non-detectable HCV RNA 24 weeks post-treatment. | Posted | Number | Participants | Assessed at 24 weeks post-treatment |
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| Secondary | Number of Participants With RVR Who Also Achieved SVR | RVR was defined as HCV RNA negative after 4 weeks of treatment. SVR was defined as non-detectable HCV RNA 24 weeks or more post-treatment. | Participants who achieved RVR at Treatment Week 4. | Posted | Number | Participants | Assessed at Treatment Week 4 (RVR) and 24 weeks post-treatment (SVR) |
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| Secondary | Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR | Participants who achieved RVR at Treatment Week 4 who were considered to have SVR (non-detectable HCV RNA at Treatment Week 48 for genotypes 2 and 3, and Treatment Week 72 for genotypes 1, 4, and 5). Participants from the Mono-infected with HCV group and the Co-infected with HCV and HIV group, were identified as either Genotype 1, 2, 3, 4, or 5. | Participants who achieved RVR at Treatment Week 4. | Posted | Number | Participants | Treatment Week 48 and Treatment Week 72 |
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| Secondary | Assessment of Baseline Characteristics in Participants With SVR | Baseline characteristics assessed were age, gender, and genotype. | Participants with SVR | Posted | Number | Participants | 24 Weeks post-treatment |
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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 | Mono-Infected With HCV | Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling. | 52 | 1,010 | 762 | 1,010 | ||
| EG001 | Co-Infected With HCV and HIV | Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling. | 0 | 72 | 61 | 72 | ||
| EG002 | Not Evaluated | 8 | 64 | 42 | 64 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
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| HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
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| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
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| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
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| ANGINA PECTORIS | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
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| CARDIAC FAILURE | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
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| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
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| HYPOACUSIS | Ear and labyrinth disorders | MedDRA 9.1 | Systematic Assessment |
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| RETINAL DETACHMENT | Eye disorders | MedDRA 9.1 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| ASCITES | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| FAECALOMA | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| HAEMATEMESIS | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| MELAENA | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| OESOPHAGEAL ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| OESOPHAGEAL VARICES HAEMORRHAGE | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| PERITONITIS | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| STOMATITIS | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA 9.1 | Systematic Assessment |
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| DEATH | General disorders | MedDRA 9.1 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 9.1 | Systematic Assessment |
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| MALAISE | General disorders | MedDRA 9.1 | Systematic Assessment |
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| MULTI-ORGAN FAILURE | General disorders | MedDRA 9.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 9.1 | Systematic Assessment |
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| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 9.1 | Systematic Assessment |
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| CHOLESTASIS | Hepatobiliary disorders | MedDRA 9.1 | Systematic Assessment |
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| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA 9.1 | Systematic Assessment |
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| JAUNDICE | Hepatobiliary disorders | MedDRA 9.1 | Systematic Assessment |
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| APPENDICITIS | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
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| CELLULITIS | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
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| CENTRAL NERVOUS SYSTEM ABSCESS | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
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| PULMONARY TUBERCULOSIS | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
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| SEPSIS | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
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| UROSEPSIS | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
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| INJURY | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
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| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
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| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
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| DIABETIC KETOACIDOSIS | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
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| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
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| METABOLIC ACIDOSIS | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
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| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Systematic Assessment |
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| ASTERIXIS | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| ENCEPHALOPATHY | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| HEPATIC ENCEPHALOPATHY | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| OPTIC NEURITIS | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| QUADRIPLEGIA | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
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| RENAL FAILURE | Renal and urinary disorders | MedDRA 9.1 | Systematic Assessment |
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| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 9.1 | Systematic Assessment |
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| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
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| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
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| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
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| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
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| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| LEG AMPUTATION | Surgical and medical procedures | MedDRA 9.1 | Systematic Assessment |
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| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
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| THROMBOPHLEBITIS | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
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| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA 9.1 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 9.1 | Systematic Assessment |
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| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 9.1 | Systematic Assessment |
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| IRRITABILITY | General disorders | MedDRA 9.1 | Systematic Assessment |
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| MALAISE | General disorders | MedDRA 9.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 9.1 | Systematic Assessment |
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| WEIGHT DECREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
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| ANOREXIA | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
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| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
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Whenever a Principal Investigator wishes to use the results of the study, he/she should contact the sponsor to obtain the authorization.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| 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 |
|---|---|
| C417083 | peginterferon alfa-2b |
| 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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