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This is an observational, multicenter, nationwide study where information will be collected on the follow-up of participants with chronic hepatitis C virus (HCV) who have a viral response at the end of treatment with pegylated interferon alfa-2b (PEG IFN alfa-2b) plus ribavirin (RBV) administered according to the directions on the products' labeling. No administration of treatment is planned as a result of study enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG IFN alfa-2b + RBV | Adult participants with chronic hepatitis C who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment during this study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Relapse At 24 Weeks After the End Of Treatment (EOT) | Relapse rate is defined as the percentage of participants with negative viral load (HCV RNA-) at EOT who have positive viral load (HCV RNA+) at 6 months after EOT. RNA= Ribonucleic Acid | From enrollment (≤4 weeks after end of treatment) to Week 24 post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Relapsed After EOT at Week 72 (Late Relapser) | Late relapse was defined as having a Sustained Viral Response (SVR) at 24 weeks of follow-up and subsequently having a positive viral load 48 weeks later at Week 72. SVR was defined as negative for HCV RNA at Week 24 of follow-up. | From 24 weeks post-treatment to 72 weeks post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Adult subjects with chronic hepatitis C who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response.
A total of 279 participants enrolled in the study. Twenty-one participants failed screening and 258 participants were evaluable at Visit 1 (V1), which could be performed up to Week (Wk) 4 after the end of treatment.
Participants who had achieved a viral response prior to this study (negative for Hepatitis C Virus [HCV] ribonucleic acid [RNA] at the end of treatment as per product label) were recruited for follow-up on the present study.
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| ID | Title | Description |
|---|---|---|
| FG000 | PEG IFN Alfa-2b + RBV | Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 (≤4 Weeks Post-treatment) |
| |||||||||||||
| Visit 2 (Week 24 Post-treatment) |
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| Visit 3 (Week 72 Post-treatment) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PEG IFN Alfa-2b + RBV | Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study. |
| 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 | Percentage of Participants With Relapse At 24 Weeks After the End Of Treatment (EOT) | Relapse rate is defined as the percentage of participants with negative viral load (HCV RNA-) at EOT who have positive viral load (HCV RNA+) at 6 months after EOT. RNA= Ribonucleic Acid | The evaluable population consisted of all enrolled participants who were virus negative at the end of treatment. 249 participants were evaluable for Week 24 (Visit 2). | Posted | Number | 95% Confidence Interval | Percentage of participants | From enrollment (≤4 weeks after end of treatment) to Week 24 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 | PEG IFN Alfa-2b + RBV | Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowning | General disorders | MedDRA 13.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 13.1 |
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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 |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Participants Who Relapsed After EOT at Week 72 (Late Relapser) | Late relapse was defined as having a Sustained Viral Response (SVR) at 24 weeks of follow-up and subsequently having a positive viral load 48 weeks later at Week 72. SVR was defined as negative for HCV RNA at Week 24 of follow-up. | The evaluable population consisted of all enrolled participants who were virus negative at the end of treatment and also virus-negative at Week 24 (Visit 2). 187 participants completed Visit 2, 14 participants were excluded from analysis, and 173 participants were evaluable for Week 72 (Visit 3). | Posted | Number | 95% Confidence Interval | Percentage of participants | From 24 weeks post-treatment to 72 weeks post-treatment |
|
|
|
| 5 |
| 258 |
| 26 |
| 258 |
| Cerebrovascular accident | Nervous system disorders | MedDRA 13.1 |
|
| Spinal Hematoma | Nervous system disorders | MedDRA 13.1 |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 13.1 |
|
| Depression | Psychiatric disorders | MedDRA 13.1 |
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| Schizophrenia, Paranoid Type | Psychiatric disorders | MedDRA 13.1 |
|
| Asthenia | General disorders | MedDRA 13.1 |
|
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| 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 |