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The objective of this study is to assess the impact of participant care and support on treatment adherence. PegIntron pen and Rebetol will be administered to participants with Hepatitis C Virus (HCV) in accordance with approved labeling. Sites will be categorized as providing high vs low level of participant management based on information about the level of participant support and management captured on the site questionnaire. Data on each participant will be collected by a physician on an electronic participant case report form (CRF) and by the participant via a questionnaire. Treatment completion rates will be analyzed based on the high vs low level of participant management.
The hypothesis is that Physicians investing more time and effort into participant management achieve higher treatment completion rates among their hepatitis C patients than physicians offering less participant management measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PegIntron | Biological | PegIntron (peginterferon alfa-2b) pen administered at a dose and frequency in accordance with approved labeling in Germany |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Biometrical Adherence to Therapy | Adherence was defined as participants receiving at least 80% of the planned PegIntron doses, or at least 80% of the planned Rebetol doses, or participants concluding at least 80% of the planned duration of their treatment, or all three conditions. | Up to 48 weeks for Hepatitis C Virus (HCV) genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3 |
| Number of Participants With Adherence to Therapy According to Physician Approximation | Adherence was based on physiciant's clinical judgment. | Up to 48 weeks for HCV genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3 |
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Inclusion Criteria:
Those participating in patient assistance programs during therapy for hepatitis C.
Exclusion Criteria:
Other exclusion criteria as described in local Summary of Product Characteristics (SPC).
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Participants with chronic hepatitis C treated in 44 non-university centers in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites. Completers are considered those with documentation who finished the study on time. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites. |
| 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 | Number of Participants With Biometrical Adherence to Therapy | Adherence was defined as participants receiving at least 80% of the planned PegIntron doses, or at least 80% of the planned Rebetol doses, or participants concluding at least 80% of the planned duration of their treatment, or all three conditions. | Posted | Number | Participants | Up to 48 weeks for Hepatitis C Virus (HCV) genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3 |
|
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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 Participants |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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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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|
| Rebetol | Drug | Rebetol (ribavirin) administered at a dose and frequency in accordance with approved labeling in Germany |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Number of Participants With Adherence to Therapy According to Physician Approximation | Adherence was based on physiciant's clinical judgment. | Posted | Number | Participants | Up to 48 weeks for HCV genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3 |
|
|
|
| 27 |
| 746 |
| 332 |
| 746 |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| BASEDOW'S DISEASE | Endocrine disorders | MedDRA 12.0 | Systematic Assessment |
|
| HYPOTHYROIDISM | Endocrine disorders | MedDRA 12.0 | Systematic Assessment |
|
| ADVERSE EVENT | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| AUTOIMMUNE HEPATITIS | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| APPENDICITIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| OSTEOMYELITIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| TOXOPLASMOSIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| NARCOTIC INTOXICATION | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| CONVULSION | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| DISTURBANCE IN ATTENTION | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| AGGRESSION | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| ALCOHOL ABUSE | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| ALCOHOL PROBLEM | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| ANXIETY DISORDER | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| MERYCISM | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| PSYCHIATRIC DECOMPENSATION | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| PSYCHOTIC DISORDER | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| RESTLESSNESS | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| SKIN BURNING SENSATION | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| APPENDICECTOMY | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| IRRITABILITY | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| INFLUENZA | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| ANOREXIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| DISTURBANCE IN ATTENTION | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| DEPRESSED MOOD | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| SLEEP DISORDER | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |