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Previous intravenous drug abusers with chronic hepatitis C who are under substitution therapy (buprenorphine, methadone) will be treated with PegIntron and Rebetol according to the approved European labeling. The study will assess the tolerability, safety and efficacy of the treatment with PegIntron plus Rebetol in this study population. The objective of the study is to collect data on the prevalence of the hepatitis C infections in drug-substituted patients. The study will also compare the feasibility of HCV (Hepatitis C Virus) treatment in patients receiving Subutex® vs other drug substitution pharmacotherapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PegIntron + Rebetol | There will be a distinction between the patients depending on the type of substitution drug used (secondary parameters). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PegIntron (pegylated interferon alfa-2b; SCH 54031) | Biological | PegIntron 1.5 μg/kg/week administered for a minimum of 12 weeks. Patients who achieve early virologic response at Treatment Week 12, will continue PegIntron therapy for a total of 24 weeks for subjects infected with HCV genotype 2 or 3, and for a total of 48 weeks for subjects infected with HCV genotype 1 or 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions | Participants who achieved SVR (sustained virological response) at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4) were analyzed for sustained response at the end of the follow-up period (24 weeks after end of treatment). SVR is defined as having negative HCV-RNA (hepatitis C virus ribonucleic acid). | End of Follow-up (Week 48 or Week 72, depending on genotype) |
| Number of Participants Who Tolerated Treatment With PegIntron 1.5 mcg/kg/Week + Rebetol 10.6 mg/kg/Week | Tolerability of the treatment was measured by number of participants with complete treatment. | Assessed at the end of treatment |
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Inclusion Criteria:
Treatment-naïve participants or relapsers to interferon monotherapy
Participants with chronic hepatitis C infection
At least 18 years of age
Must meet the following laboratory criteria:
Ex-intravenous drug abusers who are under stable substitution therapy
Women of childbearing potential must practice adequate contraception and have a routine pregnancy test performed monthly during treatment and for 7 months post-treatment.
Sexually-active participants must be practicing acceptable methods of contraception during the treatment and for 7 months post-treatment
Exclusion Criteria:
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Previous intravenous drug abusers with chronic hepatitis C receiving substitution therapy (buprenorphine, methadone or other) at approximately 100 sites in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | PegIntron + Rebetol | PegIntron 1.5 mcg/kg/week + Rebetol 10.6 mg/kg/day administered for a minimum of 12 weeks. Participants who achieved early virological response at Treatment Week 12 continued to receive therapy for a total of 24 or 48 weeks, depending on genotype. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Rebetol (ribavirin; SCH 18908) | Drug | Rebetol administered at 10.6 mg/kg/day for a minimum of 12 weeks. Patients who achieve early virologic response at Treatment Week 12, will continue Rebetol therapy for a total of 24 weeks for subjects infected with HCV genotype 2 or 3, and for a total of 48 weeks for subjects infected with HCV genotype 1 or 4 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PegIntron + Rebetol | Baseline measures only available for the 118 participants who completed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex/Gender, Customized | Number | participants |
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| Region of Enrollment | 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 Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions | Participants who achieved SVR (sustained virological response) at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4) were analyzed for sustained response at the end of the follow-up period (24 weeks after end of treatment). SVR is defined as having negative HCV-RNA (hepatitis C virus ribonucleic acid). | Participants who achieved SVR at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4) | Posted | Number | Participants | End of Follow-up (Week 48 or Week 72, depending on genotype) |
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| Primary | Number of Participants Who Tolerated Treatment With PegIntron 1.5 mcg/kg/Week + Rebetol 10.6 mg/kg/Week | Tolerability of the treatment was measured by number of participants with complete treatment. | All enrolled participants | Posted | Number | participants | Assessed at the end of treatment |
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Non-serious adverse events (AEs) were not captured as part of the study database. Nevertheless, at the end of each visit, physicians were asked to state if an AE occurred since the last visit. Therefore, it is possible to show only the total number of AEs, which was 104 in the 118 complete participants and 224 in all 246 enrolled participants.
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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 | PegIntron + Rebetol | PegIntron 1.5 mcg/kg/week + Rebetol 10.6 mg/kg/day administered for a minimum of 12 weeks. Participants who achieved early virological response at Treatment Week 12 continued to receive therapy for a total of 24 or 48 weeks, depending on genotype. | 4 | 246 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endocarditis | Infections and infestations | MedDRA 12.1 |
| ||
| Pneumonia | Infections and infestations | MedDRA 12.1 |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 12.1 |
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| Convulsion | Nervous system disorders | MedDRA 12.1 |
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| Pregnancy of partner | Social circumstances | MedDRA 12.1 |
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Trial results belong to the Sponsor only, all investigators are not allowed to publish trial results without permission of the Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D015819 | Substance Abuse, Intravenous |
| 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 |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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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| Unavailable |
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| Title | Measurements |
|---|---|
|
| Opioid substitution with other medication (n=1) |
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| No opioid substitution medication (n=9) |
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| Title | Denominators | Categories |
|---|
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