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The objective of the study is to assess the safety and efficacy of PegIntron injector and Rebetol administered to participants with chronic hepatitis C. Participants will be treated by general practitioners in clinical practice as part of the post-marketing surveillance study. The study will assess the rates of eradication of the hepatits C virus and the rates of serious adverse events reported with PegIntron (1.5 μg/kg/week) and Rebetol (800-1200 mg/day) in common medical practice in Germany.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PegIntron + Rebetol | Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PegIntron (peginterferon alfa-2b; SCH 54031) injector | Biological | PegIntron administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative Participants at End of Therapy (EoT) | HCV-RNA level was measured by polymerase chain reaction (PCR). | 24 weeks in genotypes 2 and 3, and 48 weeks in genotypes 1, 4, 5, and 6 |
| Number of Participants With Early Virologic Response (EVR) | EVR was defined as at least a 2 log reduction in HCV-RNA or HCV-RNA negativity from baseline to Week 12 | Treatment Week 12 |
| Number of Participants With Sustained Virologic Response (SVR) | SVR was defined as HCV-RNA negativity at EoT and at the follow-up 6 months after the EoT | 24 weeks post-treatment (Week 48 or 72, depending on genotype) |
| Number of HCV-RNA Negative Participants at Follow-up | HCV-RNA was measured by PCR. | 24 weeks post-treatment (Weeks 48 or 72, depending on genotype) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with chronic hepatitis C, who are either treatment-naïve or previous relapsers after interferon monotherapy, from 500 sites in Germany
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| ID | Title | Description |
|---|---|---|
| FG000 | PegIntron + Rebetol | Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling. Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Rebetol (ribavirin; SCH 18908) | Drug | Rebetol administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PegIntron + Rebetol | Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling. Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling. |
| 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, Continuous | Mean age was for the evaluable population of 1986 participants. | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | 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 | Number of Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative Participants at End of Therapy (EoT) | HCV-RNA level was measured by polymerase chain reaction (PCR). | Number of evaluable participants at EoT | Posted | Number | Participants | 24 weeks in genotypes 2 and 3, and 48 weeks in genotypes 1, 4, 5, and 6 |
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| ||||||||||||||||||||||||||
| Primary | Number of Participants With Early Virologic Response (EVR) | EVR was defined as at least a 2 log reduction in HCV-RNA or HCV-RNA negativity from baseline to Week 12 | Number of evaluable participants at 12 weeks of treatment | Posted | Number | Participants | Treatment Week 12 |
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| |||||||||||||||||||||||||||
| Primary | Number of Participants With Sustained Virologic Response (SVR) | SVR was defined as HCV-RNA negativity at EoT and at the follow-up 6 months after the EoT | Number of evaluable participants with follow-up information | Posted | Number | Participants | 24 weeks post-treatment (Week 48 or 72, depending on genotype) |
|
| |||||||||||||||||||||||||||
| Primary | Number of HCV-RNA Negative Participants at Follow-up | HCV-RNA was measured by PCR. | Number of participants with results at the 6 month follow-up examination | Posted | Number | Participants | 24 weeks post-treatment (Weeks 48 or 72, depending on genotype) |
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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 | All Participants | 58 | 2,302 | 151 | 2,302 |
| 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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| LEUKOPENIA | 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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| PALPITATIONS | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| HYPERTHYROIDISM | Endocrine disorders | MedDRA 12.0 | Systematic Assessment |
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| ABDOMINAL DISCOMFORT | 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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| NAUSEA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| ADVERSE EVENT | General disorders | MedDRA 12.0 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA 12.0 | Systematic Assessment |
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| DEATH | General disorders | MedDRA 12.0 | Systematic Assessment |
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| ENANTHEMA | General disorders | MedDRA 12.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 12.0 | Systematic Assessment |
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| INJECTION SITE INFLAMMATION | General disorders | MedDRA 12.0 | Systematic Assessment |
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| INJECTION SITE PRURITUS | General disorders | MedDRA 12.0 | Systematic Assessment |
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| MALAISE | General disorders | MedDRA 12.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 12.0 | Systematic Assessment |
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| HYPERSENSITIVITY | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
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| HERPES ZOSTER OPHTHALMIC | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| SEPSIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| UROSEPSIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| FALL | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| BLOOD COUNT | Investigations | MedDRA 12.0 | Systematic Assessment |
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| HAEMOGLOBIN DECREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
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| RED BLOOD CELL COUNT DECREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
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| WEIGHT DECREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
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| ANOREXIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| HYPERURICAEMIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| CEREBELLAR INFARCTION | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| DISTURBANCE IN ATTENTION | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| DIZZINESS | 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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| HEADACHE | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| HYPOTONIA | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| SOMNOLENCE | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| AGGRESSION | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| COMPLETED SUICIDE | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| DEPENDENCE | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| DEPRESSED MOOD | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| LISTLESS | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| MENTAL DISORDER DUE TO A GENERAL MEDICAL CONDITION | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| MIDDLE INSOMNIA | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| MOOD SWINGS | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| PSYCHOTIC DISORDER | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| SUICIDE ATTEMPT | Psychiatric 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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| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| DRUG ERUPTION | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
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| PELVIC VENOUS THROMBOSIS | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FATIGUE | General disorders | MedDRA 12.0 | Systematic Assessment |
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All rights according to the results belong to Essex, Germany. Publications or transmission of data need a previous written agreement of the company.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclsoure@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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| Gender information not captured |
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