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Enrolled patients will be recruited to two parallel groups during therapy for Hepatitis C. Patients in the first one will receive a patient assistance program, and patients in the second group will not. All patients will receive PegIntron and Rebetol according to label.
Non-Probability Sample, Commercial product used according to EU label.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment and Patient Assistance Program | Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events. |
| |
| Treatment Alone | PegIntron/Rebetol treatment only. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PegIntron (peginterferon alfa-2b; SCH 54031) | Biological | Peginterferon alfa-2b will be administered according to the product's labeling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C | Participant adherence to therapy was compared between participants treated with PegIntron/Rebetol either with or without a patient assistance program | At the end of the 48-week treatment period |
| The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment | Sustained virologic response is defined as having an undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of treatment and 6 months post-treatment | Measured at 6 months post-treatment |
| The Number of Participants Who Relapsed at 6 Months Post-treatment | Participants who relapse are defined as having an undetectable HCV-RNA at the end of treatment but detectable HCV-RNA at 6 months post-treatment | Measured at end of treatment and 6 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Average Length of Treatment | Participant adherence to therapy was compared between participants who received vs not received a patient assistance program in addition to their PegIntron/Rebetol treatment. | Maximum 48-week treatment duration |
| Average Dosage of PegIntron |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic HCV.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment and Patient Assistance Program | Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Rebetol (ribavirin; SCH 18908) | Drug | Ribavirin will be administered according to the product's labeling. |
|
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| Patient Assistance Program | Behavioral | The patient assistance program includes the following:
|
|
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Dosage of PegIntron was expressed in terms of micrograms of PegIntron received per kilogram of participant's body weight per week |
| Up to 48-week treatment duration |
| Average Dosage of Rebetol | Rebetol dosage was expressed in milligrams per kilogram of body weight per day. | Up to 48-week treatment duration |
| FG001 | Treatment Alone | PegIntron/Rebetol treatment only |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment and Patient Assistance Program | Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events. |
| BG001 | Treatment Alone | PegIntron/Rebetol treatment only |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| 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 Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C | Participant adherence to therapy was compared between participants treated with PegIntron/Rebetol either with or without a patient assistance program | Posted | Number | Participants | At the end of the 48-week treatment period |
|
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| ||||||||||||||||||||||||||||||
| Secondary | Average Length of Treatment | Participant adherence to therapy was compared between participants who received vs not received a patient assistance program in addition to their PegIntron/Rebetol treatment. | Posted | Number | Participants | Maximum 48-week treatment duration |
|
| |||||||||||||||||||||||||||||||
| Secondary | Average Dosage of PegIntron | Dosage of PegIntron was expressed in terms of micrograms of PegIntron received per kilogram of participant's body weight per week | Posted | Mean | Standard Deviation | micrograms/kg/week | Up to 48-week treatment duration |
|
| ||||||||||||||||||||||||||||||
| Secondary | Average Dosage of Rebetol | Rebetol dosage was expressed in milligrams per kilogram of body weight per day. | Posted | Mean | Standard Deviation | mg/kg/day | Up to 48-week treatment duration |
|
| ||||||||||||||||||||||||||||||
| Primary | The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment | Sustained virologic response is defined as having an undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of treatment and 6 months post-treatment | Posted | Number | Participants | Measured at 6 months post-treatment |
|
| |||||||||||||||||||||||||||||||
| Primary | The Number of Participants Who Relapsed at 6 Months Post-treatment | Participants who relapse are defined as having an undetectable HCV-RNA at the end of treatment but detectable HCV-RNA at 6 months post-treatment | Posted | Number | Participants | Measured at end of treatment and 6 months 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 | Treatment and Patient Assistance Program | 0 | 60 | 39 | 60 | |||
| EG001 | Treatment Alone | 0 | 39 | 28 | 39 |
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| 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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| GRANULOCYTOPENIA | 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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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| VERTIGO | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA 12.0 | Systematic Assessment |
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| CHEST PAIN | General disorders | MedDRA 12.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 12.0 | Systematic Assessment |
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| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 12.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 12.0 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
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| WEIGHT DECREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
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| APPETITE DISORDER | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| DYSTHYMIC DISORDER | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| INSOMNIA | 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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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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All the information obtained in the course of conducting the study, including all data concerning the study and its results, are confidential and cannot be disclosed to any third parties without the consent of Schering-Plough.
| 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 |
| D000488 | Allied Health Personnel |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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| Male |
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