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The current gold standard for treatment of chronic hepatitis C (CHC) patients is with pegylated interferon plus ribavirin. Drug administration accuracy and ease of use will definitely determine treatment effectiveness. This is the idea behind the development and usage of the PegPen. The goal of this study is to determine the satisfaction grade with this novel device.
Enrollment of patients will occur in a sequential order of treatment initiation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with chronic hepatitis C | Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2b (SCH 54031) | Biological | Peginterferon alfa-2b will be administered according to the products' labeling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months | Patient satisfaction for each item on the questionnaires was rated on a scale from 0 (not satisfied) to 7 (very satisfied). | The patient was instructed to answer and return by mail the first self-questionnaire after 1 month of treatment and the second one after 3 months of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol at sites in France.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Director | Merck Sharp & Dohme LLC | Study Director |
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Enrolled: 1995 subjects; all questionnaires were returned for 940 subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Chronic Hepatitis C | Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Chronic Hepatitis C | Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol. Results presented concern only participants with all questionnaires returned (940). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months | Patient satisfaction for each item on the questionnaires was rated on a scale from 0 (not satisfied) to 7 (very satisfied). | Both patient questionnaires were returned by 940 subjects. However, some items were not rated on the returned questionnaires. The missing data for questionnaire items range from 24 subjects to 72 subjects. | Posted | Mean | Standard Deviation | satisfaction rating from 0-7 | The patient was instructed to answer and return by mail the first self-questionnaire after 1 month of treatment and the second one after 3 months of treatment. |
|
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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, therefore, none were collected, and the number at risk is zero.
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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 | Patients With Chronic Hepatitis C | Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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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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| Ribavirin (SCH 18908) | Drug | Ribavirin will be administered according to the products' labeling. |
|
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| years |
|
| Sex/Gender, Customized | Number | Participants |
|
| Region of Enrollment | Number | Participants |
|
| OG001 | After 3 Months of Treatment | Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol. |
|
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| 0 |
| 0 |
| 0 |
| 0 |
Any publication or communication (written or oral) could be performed by the Principal Investigator only after written approval from Schering-Plough.
| 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 |