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Although injection drug users represent the majority of new and existing cases of infection with hepatitis C virus (HCV), many lack access to treatment because of concerns about adherence, effectiveness, and reinfection. On the basis of a small but growing body of evidence showing that injection drug users can undergo treatment for HCV infection successfully, the 2002 NIH Consensus Statement on Hepatitis C has recommended that substance users be treated for HCV infection on a case-by-case basis. In this study, all patients will receive pegylated interferon alfa-2b (PegIFN-2b) and ribavirin according to European labeling; one cohort of participants will also be receiving substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PegIFN-2b/ribavirin with substitution therapy | Participants in this cohort received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine) |
| |
| PegIFN-2b/ribavirin without substitution therapy | Participants in this cohort received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated interferon alfa-2b (PegIFN-2b) | Biological | PegIFN-2b administered according to European labeling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin | For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24. | 24 to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved Sustained Virologic Response (SVR) | SVR was defined as a hepatitis C virus (HCV) ribonucleic acid (RNA) value below the limit of detection by polymerase chain reaction (PCR) analysis. For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients receiving treatment for hepatitis C with/without substitution therapy at sites in Austria.
353 participants were enrolled on the study; 348 were treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | PegIFN-2b/Ribavirin With Substitution Therapy | Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine) |
| FG001 | PegIFN-2b/Ribavirin Without Substitution Therapy | Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PegIFN-2b/Ribavirin With Substitution Therapy | Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine) |
| BG001 | PegIFN-2b/Ribavirin Without Substitution Therapy |
| 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 Who Completed Treatment With PegIFN-2b/Ribavirin | For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24. | Participants who received at least one dose of PegIFN-2b/ribavirin | Posted | Number | participants | 24 to 48 weeks |
|
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All participants who received at least one dose of study therapy.
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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 | PegIFN-2b/Ribavirin With Substitution Therapy | Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
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| 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 |
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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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|
| Ribavirin | Drug | Ribavirin administered according to European labeling. |
|
|
| 24 weeks after the end of treatment (i.e. 48 or 72 weeks depending on genotype) |
| Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy | This measure was the number of all of the participants who received antiviral treatment who also received substitution therapy. | Day 1 |
Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
|
|
| Secondary | Number of Participants Who Achieved Sustained Virologic Response (SVR) | SVR was defined as a hepatitis C virus (HCV) ribonucleic acid (RNA) value below the limit of detection by polymerase chain reaction (PCR) analysis. For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24. | All treated participants. | Posted | Number | participants | 24 weeks after the end of treatment (i.e. 48 or 72 weeks depending on genotype) |
|
|
|
| Secondary | Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy | This measure was the number of all of the participants who received antiviral treatment who also received substitution therapy. | Participants who received at least one dose of antiviral treatment. | Posted | Number | participants | Day 1 |
|
|
|
| 1 |
| 90 |
| 18 |
| 90 |
| EG001 | PegIFN-2b/Ribavirin Without Substitution Therapy | Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine) | 10 | 258 | 35 | 258 |
| Blood disorder | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
|
| Accidental death | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
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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 |