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The objective of the study is to evaluate the rates of Hepatitis C virus (HCV) eradication and relapse in participants treated with PegIntron and Rebetol in clinical practice in Greece. Participants will not be treated as part of the study. Data on participants treated in accordance with approved labeling will be collected retrospectively from approximately 30 sites in Greece.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Chronic Hepatitis C | Treatment-naïve participants with chronic hepatitis C, undergoing treatment with a standard treatment regimen of PegIntron and Rebetol in clinical practice at approximately 28 sites in Greece |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PegIntron (peginterferon alfa-2b, pegylated interferon alfa-2b) | Biological | Prior to enrollment in the study, PegIntron was to be administered at a dose of 1.5 μg/kg/week subcutaneously in accordance with approved labeling. Therapy duration varied from 24 to 48 weeks depending on HCV viral load and genotype followed by a 24-week post-treatment follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up | Sustained virological response (SVR) was assessed at the 24-week post-treatment follow-up (Visit 2). SVR was defined as undetectable plasma Hepatitis C virus Ribonucleic acid (HCV-RNA) at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration). | 24 weeks following completion of 24 or 48 weeks of therapy |
| Number of Participants Who Demonstrated Virological Relapse as Assessed at 24-week Post-treatment Follow-up | Virological relapse was assessed at the 24-week post-treatment follow-up (Visit 2). Virological relapse was defined as undetectable plasma HCV-RNA at end of combination treatment (Visit 1- considered Week 24 or Week 48 after treatment start depending on treatment duration), but with positive HCV-RNA at the 24-week post treatment follow-up. | 24 weeks following completion of 24 or 48 weeks of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV Genotype at Baseline | SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on HCV genotype (1, 2, 3, 4, or 2 & 3) at baseline. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration). |
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Inclusion Criteria:
Exclusion Criteria:
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Treatment-naïve participants with chronic hepatitis C treated with PegIntron and Rebetol in accordance with approved labeling in clinical practice in Greece prior to enrollment in the current study. Data from patients treated at approximately 28 sites will be retrospectively analyzed.
401 participants were screened for eligibility. 332 participants were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pegylated Interferon Alpha-2b and Ribavirin | Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Rebetol (ribavirin) | Drug | Prior to enrollment in the study, Rebetol was to be administered at a dose of 800-1200 mg/day orally in accordance with approved labeling. Therapy duration varied from 24 to 48 weeks depending on HCV viral load and genotype followed by a 24-week post-treatment follow-up. |
|
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| 24 weeks following completion of 24 or 48 weeks of therapy |
| Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Liver Fibrosis Stage at Baseline | SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on liver fibrosis stage, where biopsy was available, at baseline: absence, minimal, moderate, or significant as assessed by investigator. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration). | 24 weeks following completion of 24 or 48 weeks of therapy |
| Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV-RNA Viral Load at Baseline | SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on HCV-RNA viral load at baseline as assessed by investigator. Low viral load was defined as <400,000 International Units/milliliter (IU/mL) and high viral load was defined as >=400,000 IU/mL. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration). | 24 weeks following completion of 24 or 48 weeks of therapy |
| Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Alanine Aminotransferase (ALT) Levels at Baseline | SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on ALT levels at baseline as assessed by investigator. Normal baseline ALT level was defined as <40 IU/mL and elevated baseline ALT level was defined as >= 40 IU/mL. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration). | 24 weeks following completion of 24 or 48 weeks of therapy |
| Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Study Treatment Dosage Modification | SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on study treatment dosage modification: no dosage modification or any dosage modification of study treatment. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration). | 24 weeks following completion of 24 or 48 weeks of therapy |
| Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Achievement of Rapid Virological Response | SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on achievement of rapid virological response (RVR) where data was available. RVR was defined as negative HCV-RNA after 4 (+/- 1) weeks of treatment. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration). | 24 weeks following completion of 24 or 48 weeks of therapy |
| Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Compliance With the 80/80/80 Rule | SVR was assessed by subgroups based on compliance with the 80/80/80 rule where data was available. 80/80/80 compliant participants were those that received >= 80% of the planned total doses of both pegylated interferon alfa-2b & ribavirin for >=80% of the duration of therapy. 3 rates were to be computed: Compliance with study duration, compliance with pegylated interferon dose, & compliance with ribavirin dose. A participant was defined as compliant, if none of the 3 rates were < than 80%. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment. | 24 weeks following completion of 24 or 48 weeks of therapy |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pegylated Interferon Alpha-2b and Ribavirin | Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up. |
| Units | Counts |
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| 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 | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | 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 Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up | Sustained virological response (SVR) was assessed at the 24-week post-treatment follow-up (Visit 2). SVR was defined as undetectable plasma Hepatitis C virus Ribonucleic acid (HCV-RNA) at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration). | Efficacy Analysis Set (EAS) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. | Posted | Number | Participants | 24 weeks following completion of 24 or 48 weeks of therapy |
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| Secondary | Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV Genotype at Baseline | SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on HCV genotype (1, 2, 3, 4, or 2 & 3) at baseline. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration). | Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. 23 participants were relapsers. | Posted | Number | Participants | 24 weeks following completion of 24 or 48 weeks of therapy |
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| Primary | Number of Participants Who Demonstrated Virological Relapse as Assessed at 24-week Post-treatment Follow-up | Virological relapse was assessed at the 24-week post-treatment follow-up (Visit 2). Virological relapse was defined as undetectable plasma HCV-RNA at end of combination treatment (Visit 1- considered Week 24 or Week 48 after treatment start depending on treatment duration), but with positive HCV-RNA at the 24-week post treatment follow-up. | Efficacy Analysis Set (EAS) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. | Posted | Number | Participants | 24 weeks following completion of 24 or 48 weeks of therapy |
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| Secondary | Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Liver Fibrosis Stage at Baseline | SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on liver fibrosis stage, where biopsy was available, at baseline: absence, minimal, moderate, or significant as assessed by investigator. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration). | Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 157 participants. | Posted | Number | Participants | 24 weeks following completion of 24 or 48 weeks of therapy |
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| Secondary | Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV-RNA Viral Load at Baseline | SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on HCV-RNA viral load at baseline as assessed by investigator. Low viral load was defined as <400,000 International Units/milliliter (IU/mL) and high viral load was defined as >=400,000 IU/mL. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration). | Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 32 participants. | Posted | Number | Participants | 24 weeks following completion of 24 or 48 weeks of therapy |
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| Secondary | Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Alanine Aminotransferase (ALT) Levels at Baseline | SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on ALT levels at baseline as assessed by investigator. Normal baseline ALT level was defined as <40 IU/mL and elevated baseline ALT level was defined as >= 40 IU/mL. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration). | Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 6 participants. | Posted | Number | Participants | 24 weeks following completion of 24 or 48 weeks of therapy |
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| Secondary | Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Study Treatment Dosage Modification | SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on study treatment dosage modification: no dosage modification or any dosage modification of study treatment. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration). | Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. | Posted | Number | Participants | 24 weeks following completion of 24 or 48 weeks of therapy |
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| Secondary | Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Achievement of Rapid Virological Response | SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on achievement of rapid virological response (RVR) where data was available. RVR was defined as negative HCV-RNA after 4 (+/- 1) weeks of treatment. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration). | Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 250 participants. | Posted | Number | Participants | 24 weeks following completion of 24 or 48 weeks of therapy |
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| Secondary | Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Compliance With the 80/80/80 Rule | SVR was assessed by subgroups based on compliance with the 80/80/80 rule where data was available. 80/80/80 compliant participants were those that received >= 80% of the planned total doses of both pegylated interferon alfa-2b & ribavirin for >=80% of the duration of therapy. 3 rates were to be computed: Compliance with study duration, compliance with pegylated interferon dose, & compliance with ribavirin dose. A participant was defined as compliant, if none of the 3 rates were < than 80%. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment. | No data had been captured in the Case Report Forms, and therefore no relevant analysis had been performed. | Posted | 24 weeks following completion of 24 or 48 weeks of therapy |
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The safety population included the total number of participants screened for eligibility (N=401). This population includes the total number of eligible participants enrolled in the study or the Full Analysis Set (N=332) and the non-eligible participants or the screening failure set (N=69).
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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 | Pegylated Interferon Alpha-2b and Ribavirin | Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up. | 5 | 401 | 123 | 401 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.1) |
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| Oedema | General disorders | MedDRA (13.1) |
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| Pain | General disorders | MedDRA (13.1) |
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| Pyrexia | General disorders | MedDRA (13.1) |
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| Lung Infection | Infections and infestations | MedDRA (13.1) |
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| Pneumonia | Infections and infestations | MedDRA (13.1) |
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| Tooth Abscess | Infections and infestations | MedDRA (13.1) |
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| Epilepsy | Nervous system disorders | MedDRA (13.1) |
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| Emotional Disorder | Psychiatric disorders | MedDRA (13.1) |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA (13.1) |
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| Thrombophlebitis | Vascular disorders | MedDRA (13.1) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.1) |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA (13.1) |
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| Fatigue | General disorders | MedDRA (13.1) | Includes Fatigue, Lassitude, and Fatigability |
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| Weight Decreased | Investigations | MedDRA (13.1) |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Includes Alopecia, Hair Loss, and Accelerated Hair Loss |
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The principal investigator agrees not to publish or publicly present any interim results of the Study without prior written consent of the SPONSOR. The principal investigator further agrees to provide forty-five (45) days written notice to the SPONSOR prior to submission for publication or presentation
to permit the SPONSOR to review copies of abstracts or manuscripts for publication which report any results of the Study. The SPONSOR shall have the right to review & comment on any presentation.
| 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 |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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