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To determine the relapse rate at 24 weeks follow up in Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) patients treated for 24 weeks with Peg Intron and Rebetol who are Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) negative at treatment week 4 and week 24. To determine the proportion of patients (%) with sustained virological response at 24 weeks post follow up treatment.
Approximately 500 patients from about 100 sites to be identified as HCV LVL G1 patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PegIntron plus Rebetol | Those with chronic Hepatitis C infected with HCV LVL G1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PegIntron | Drug | 1.5 ug/kg/week |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of HCV LVL G1 Participants Who Relapsed | Relapse was defined as undetectable Hepatitis C virus-ribonucleic acid (HCV-RNA) at End of Treatment, but detectable HCV-RNA at Follow-up Week 24. | Week 24 of follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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primary care clinic
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22239509 | Result | Craxi A, Koutsounas S, Ogurtsov P, Chemello L, Maticic M, Torras J, Diago M, Tartaglione MT, Witthoeft T, Yu X, Faruqi R, Chaudhri E, Pedicone LD, Zuckerman E. Peginterferon alfa-2b plus weight-based ribavirin for 24 weeks in patients with chronic hepatitis C virus genotype 1 with low viral load who achieve rapid viral response. J Viral Hepat. 2012 Feb;19(2):e120-5. doi: 10.1111/j.1365-2893.2011.01515.x. Epub 2011 Sep 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PegIntron Plus Rebetol | Those with chronic Hepatitis C infected with Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) and treated withPeg-Intron 1.5 μg/kg/week plus Rebetol (ribavirin) 800-1200 mg/day who achieved a negative Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) at Week 4 and at Week 24 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PegIntron Plus Rebetol | Those with chronic Hepatitis C infected with Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) and treated withPeg-Intron 1.5 μg/kg/week plus Rebetol (ribavirin) 800-1200 mg/day who achieved a negative HCV-RNA at Week 4 and at Week 24 (n = 170) |
| 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 HCV LVL G1 Participants Who Relapsed | Relapse was defined as undetectable Hepatitis C virus-ribonucleic acid (HCV-RNA) at End of Treatment, but detectable HCV-RNA at Follow-up Week 24. | The 165 participants analyzed is from the efficacy evaluable population (170) minus 5 subjects who did not have follow-up data. | Posted | Number | Participants | Week 24 of follow-up |
|
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Number analyzed is the number of treated participants (482 of the 496 screened).
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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 | PegInton Plus Rebetol |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PERICARDITIS | Cardiac disorders | MedDRA 11.1 | 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 |
| 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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Blood sample for PCR
| Rebetol | Drug | 800-1200 mg/day |
|
|
| Discontinued treatment |
|
| Did not enter follow-up |
|
| Discontinued follow-up |
|
| Disease progression |
|
| Lost to Follow-up |
|
| Non-compliance |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| 11 |
| 482 |
| 0 |
| 482 |
| VERTIGO | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
|
| HYPOTHYROIDISM | Endocrine disorders | MedDRA 11.1 | Systematic Assessment |
|
| PANCREATITIS | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| ABSCESS NECK | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| MULTIPLE INJURIES | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| ACUTE PSYCHOSIS | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| AGGRESSION | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| PERSONALITY DISORDER | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| THROMBOSIS | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
Lead investigator agrees not to publish or publicly present any interim results of the Study without prior written consent of the sponsor. Lead investigator further agrees to provide 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. Sponsor shall have the right to review and comment on any presentation, including editorial rights.
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |