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The objective of the study is to evaluate the effectiveness of PegIntron plus Rebetol combination in treating patients with chronic hepatitis C in a primary care setting. Patients received no antiviral therapy prior to the current study. Only patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6 will be enrolled in the study. The study will also explore the influence of liver fibrosis stage on the chances of achieving a sustained virologic response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PegIntron Plus Rebetol | Previously untreated patients infected with HCV genotype 1, 4, 5, or 6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PegIntron (peginterferon alfa-2b; SCH 54031) | Biological | PegIntron 1.5 ug/kg body weight per week subcutaneously for 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Study Participants Who Had a Virological Response (VR) at Week-72 | VR was defined as the absence of Hepatitis C virus Ribonucleic Acid (HCV RNA) in a qualitative Polymerase Chain Reaction (PCR) test. Participants who dropped out or were withdrawn from treatment were considered not to respond. | Treatment Week 72 |
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Inclusion Criteria:
Exclusion Criteria:
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Previously untreated patients with chronic hepatitis C, infected with HCV genotype 1, 4, 5, or 6, receiving treatment with PegIntron and Rebetol.
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| ID | Title | Description |
|---|---|---|
| FG000 | PegIntron Plus Rebetol | Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Rebetol (ribavirin; SCH 18908) | Drug | Rebetol administered based on body weight 800-1200 mg/day (<65 kg: 800 mg; 65 - 85 kg: 1000 mg; >85 kg: 1200 mg) orally for 48 weeks |
|
|
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | PegIntron Plus Rebetol | Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||||||||||||
| Sex/Gender, Customized | Number | 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 | Number of Study Participants Who Had a Virological Response (VR) at Week-72 | VR was defined as the absence of Hepatitis C virus Ribonucleic Acid (HCV RNA) in a qualitative Polymerase Chain Reaction (PCR) test. Participants who dropped out or were withdrawn from treatment were considered not to respond. | Full Analysis Set (FAS)was analyzed. FAS consisted of all participants in the intent-to-treat population wih non-missing viral response at Week 72. | Posted | Number | Participants | Treatment Week 72 |
|
|
|
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Per protocol, non-serious adverse events and serious adverse events were not required to be captured as part of the study database.
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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 Plus Rebetol | Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6. | 0 | 0 | 0 | 0 |
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The participating physician (PP) agrees not to publish/present any
interim results of the Survey without prior written consent of Schering-
Plough (SP). The PP further agrees to provide 30 days written notice to SP prior to submission for publication or presentation to permit SP to review and comment on any presentation, which right shall include editorial rights. If the parties disagree, the PP agrees to meet with SP to discuss and resolve any such issues or disagreement.
| 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 |
|---|---|
|
| Gender not available |
|