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In February 2002, a French Consensus Conference on the management of patients with chronic hepatitis C in France was organized. The jury issued several recommendations on pegylated alpha interferon/ribavirin treatment strategy. Three years after these recommendations, it is of interest to understand the evolution of hepatitis C management in France in real clinical practice. This observational study will permit the identification of patients who are treated and will provide information on the use of PegIntron/ Ribavirin.
To assure a good representation of participants treated for hepatitis C, participants who meet the inclusion criteria will be enrolled on a consecutive basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PegIntron as monotherapy or in combination with Ribavirin. | Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2b (SCH 54031) | Biological | Peginterferon alfa-2b as monotherapy or in combination with ribavirin will be administered according to the products' labeling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants Receiving the Recommended Treatment Duration (24 Weeks for Genotypes 2 and 3 and 48 Weeks for Genotype 1 According to the French 2002 Consensus Meeting). | Physicians will complete a questionnaire at these visits: treatment initiation; 12 and 24 weeks after treatment initiation and 24 weeks after the end of treatment; and 36 and 48 weeks after treatment initiation for participants treated for 48 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin at academic centers, clinics, and private practices in France.
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| ID | Title | Description |
|---|---|---|
| FG000 | PegIntron as Monotherapy or in Combination With Ribavirin | Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Ribavirin (SCH 18908) | Drug | Peginterferon alfa-2b as monotherapy or in combination with ribavirin will be administered according to the products' labeling. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PegIntron as Monotherapy or in Combination With Ribavirin | Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin. |
| 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 | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex/Gender, Customized | Gender is provided for the patients that were included in the analysis (781); gender is unknown for the eight (8) participants that were not included in the analysis. | Number | 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 | The Number of Participants Receiving the Recommended Treatment Duration (24 Weeks for Genotypes 2 and 3 and 48 Weeks for Genotype 1 According to the French 2002 Consensus Meeting). | For the 48 week treatment period, the analysis did not separate Genotype 1 (G1) from Genotype 4 (G4) or others. Of the 789 participants, 8 were excluded from analysis (3 for lack of data; 5 because they were untreated). | Posted | Number | Participants | Physicians will complete a questionnaire at these visits: treatment initiation; 12 and 24 weeks after treatment initiation and 24 weeks after the end of treatment; and 36 and 48 weeks after treatment initiation for participants treated for 48 weeks. |
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Per protocol, adverse events were not collected; therefore, they were not reported. Serious Adverse Event (SAE) cases were reported by the investigators to the safety department and reported below.
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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 | PegIntron as Monotherapy or in Combination With Ribavirin | 66 | 789 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| ANAEMIA MACROCYTIC | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| HYPERSPLENISM | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| THROMBOCYTOPENIC PURPURA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| ANGINA PECTORIS | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| CARDIAC DISORDER | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| CARDIAC FAILURE | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| CORONARY ARTERY INSUFFICIENCY | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| SINUS TACHYCARDIA | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| OTOTOXICITY | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
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| HYPERTHYROIDISM | Endocrine disorders | MedDRA 12.0 | Systematic Assessment |
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| HYPOTHYROIDISM | Endocrine disorders | MedDRA 12.0 | Systematic Assessment |
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| CONJUNCTIVITIS | Eye disorders | MedDRA 12.0 | Systematic Assessment |
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| IRIDOCYCLITIS | Eye disorders | MedDRA 12.0 | Systematic Assessment |
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| OCULAR HYPERTENSION | Eye disorders | MedDRA 12.0 | Systematic Assessment |
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| RETINAL VEIN OCCLUSION | Eye disorders | MedDRA 12.0 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| ASCITES | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA 12.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 12.0 | Systematic Assessment |
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| CHOLANGITIS | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
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| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
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| HEPATOTOXICITY | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
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| PORTAL HYPERTENSION | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
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| PORTAL VEIN THROMBOSIS | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
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| AUTOIMMUNE DISORDER | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
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| INJECTION SITE ABSCESS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| RECTAL ABSCESS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| STAPHYLOCOCCAL SEPSIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| SUPERINFECTION | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| ANIMAL BITE | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| INTENTIONAL OVERDOSE | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| PATERNAL DRUGS AFFECTING FOETUS | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| SPLENIC RUPTURE | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| BIOPSY LIVER | Investigations | MedDRA 12.0 | Systematic Assessment |
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| ENDOSCOPY GASTROINTESTINAL NORMAL | Investigations | MedDRA 12.0 | Systematic Assessment |
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| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| DIABETIC COMPLICATION | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| TYPE 1 DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| PSORIATIC ARTHROPATHY | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| HEPATIC NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
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| LIP AND/OR ORAL CAVITY CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
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| COMA | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| EPILEPSY | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| TREMOR | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| COMPLETED SUICIDE | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| DELUSION | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| DEPRESSION SUICIDAL | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| MAJOR DEPRESSION | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| NERVOUSNESS | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| PARANOIA | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| PSYCHOTIC DISORDER | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| HAEMATURIA | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
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| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| PULMONARY FIBROSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| ALCOHOL DETOXIFICATION | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
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| HOSPITALISATION | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
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| PHLEBITIS | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
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Any published results concerning the data of the non-interventional study is forbidden. Study data and results are exclusive property of the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.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 |
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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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| Unavailable |
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