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| ID | Type | Description | Link |
|---|---|---|---|
| MK-4031-245 | Other Identifier | Merck |
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Several psychiatric adverse events (eg, depression, fatigue, psychoses, behavior troubles, anxiety, irritability, deteriorated concentration, and insomnia) that are likely to occur during the treatment course with PegIntron plus Rebetol may prompt patients to discontinue their treatment early. The goal of this study is to assess whether a psychotherapy support program may contribute to a better adherence rate.
Enrollment of participants will occur in a sequential order of treatment initiation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PegIntron/Rebetol and psychotherapy support program | Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C. |
| |
| PegIntron/Rebetol alone (no psychotherapy) | Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2b (PegIntron) | Biological | Peginterferon alfa-2b (PegIntron) was administered based on the prescribed dose. The average dose for PegIntron was a weekly injection of 1.5 ± 0.3 μg^kg^week |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C When Administered With a Patient Psychotherapy Support Program as Compared to a Group Without a Psychotherapy Support Program. | 12 months after onset of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol | 12 months after onset of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Participants at sites in France who are receiving a psychotherapy support program during therapy for hepatitis C and a control group without a psychotherapy support program.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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Only 568 participants were assigned to treatment as they were foreseen to complete treatment, were consulted, and met inclusion criteria.
614 participants were recruited in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | PegIntron/Rebetol and Psychotherapy Support Program | Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C. |
| FG001 | PegIntron/Rebetol Alone (no Psychotherapy) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Rebetol (Ribavirin) | Drug | Rebetol was administered orally based on the prescribed dose. The average dose for Rebetol was 950 ± 167.2 mg^day |
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| Psychotherapy support program | Behavioral | Each site has implemented a psychotherapy support program. |
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Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PegIntron/Rebetol and Psychotherapy Support Program | Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C. |
| BG001 | PegIntron/Rebetol Alone (no Psychotherapy) | Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C. |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants foreseen to complete treatment, consulted and assigned to treatment were analyzed. | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Participants foreseen to complete treatment, consulted and assigned to treatment were analyzed. | Number | participants |
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| Region of Enrollment | Participants foreseen to complete treatment, consulted and assigned to treatment were analyzed. | 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 Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C When Administered With a Patient Psychotherapy Support Program as Compared to a Group Without a Psychotherapy Support Program. | Participants foreseen to complete treatment, consulted and assigned to treatment were analyzed. | Posted | Number | Participants | 12 months after onset of treatment |
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| Secondary | the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol | Participants with no missing results. | Posted | Mean | Standard Deviation | Weeks | 12 months after onset of treatment |
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Adverse events and serious adverse events were based on the number of participants recruited and enrolled (N=614).
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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 Enrolled Participants | 11 | 614 | 0 | 614 |
| 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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| Myocardial Infarction | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| Basedow's Disease | Endocrine disorders | MedDRA 12.0 | Systematic Assessment |
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| Drug Intolerance | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Bronchopulmonary Aspergillosis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Pulmonary Tuberculosis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Transient Ischemic Attack | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Persecutory Delusion | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Dermatitis Exfoliative | 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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Data publishing of the observational study is forbidden. Data and results of the observational study are the exclusive property of the Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800--672-6372 | 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 |
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| Unavailable (missing data) |
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