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Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron pen and Rebetol according to label and the patient assistance program. This study will be compared to similar studies from other clinics using various patient support programs for the purpose of designing future comparative phase IV studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with hepatitis C | Patients receiving a patient assistance program during therapy for hepatitis C at sites in Austria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2b (SCH 54031) | Biological | Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Complete Treatment With PegIntron Pen/Rebetol Therapy for Hepatitis C When Administered With a Patient Assistance Program | 24 or 48 weeks (depending on genotype) and 24 weeks of follow up | |
| Average Length of Treatment With PegIntron/Rebetol | After start of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients receiving a patient assistance program during therapy for hepatitis C at sites in Austria.
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| ID | Title | Description |
|---|---|---|
| FG000 | PegIntron Pen/Rebetol Without Patient Assistance Program | PegIntron & Rebetol will be administered according to the products' labeling. |
| FG001 | PegIntron Pen/Rebetol With Patient Assistance Program |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Ribavirin (SCH 18908) | Drug | Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling. |
|
|
| Patient assistance program | Behavioral | Assistance programs will be classified as follows:
In Austria, sites with adherence nurses and side effect handouts will be compared with sites using side effect handouts only. |
|
PegIntron & Rebetol will be administered according to the products' labeling. Assistance programs include medications used prophylactically or for treatment (Growth factors: RBC and neutrophil; Psychiatric medications; Other
medications) - Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature).
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PegIntron Pen/Rebetol Without Patient Assistance Program | PegIntron & Rebetol will be administered according to the products' labeling. |
| BG001 | PegIntron Pen/Rebetol With Patient Assistance Program | PegIntron & Rebetol will be administered according to the products' labeling. Assistance programs include medications used prophylactically or for treatment (Growth factors: RBC and neutrophil; Psychiatric medications; Other medications) - Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature). |
| 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 |
|
| 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 Participants Who Complete Treatment With PegIntron Pen/Rebetol Therapy for Hepatitis C When Administered With a Patient Assistance Program | All participants | Posted | Number | Participants | 24 or 48 weeks (depending on genotype) and 24 weeks of follow up |
|
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| ||||||||||||||||||||||||||||||
| Primary | Average Length of Treatment With PegIntron/Rebetol | Number of participants who received study drug | Posted | Mean | Standard Deviation | Weeks | After start of treatment |
|
|
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Population for Adverse Event reporting is based on all participants who received study drug (N=597).
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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 Pen/Rebetol | 20 | 597 | 100 | 597 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| INJECTION SITE REACTION | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ABSCESS SWEAT GLAND | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| TUBERCULOSIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| SMEAR CERVIX ABNORMAL | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| BREAST CANCER IN SITU | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| HEPATIC NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| RECTAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
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| MYELOPATHY | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| ACUTE PSYCHOSIS | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
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| ALCOHOL ABUSE | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
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| MAJOR DEPRESSION | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
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| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
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| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
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| RENAL COLIC | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HOSPITALISATION | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
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| 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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| Male |
|
|