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| Name | Class |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
| Onze Lieve Vrouwe Gasthuis | OTHER |
| UMC Utrecht | OTHER |
| University Medical Center Groningen |
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Prospective open label proof of concept feasibility interventional clinical trial in which 60 acute HCV genotype 1 patients co-infected with HIV will receive 12 weeks of boceprevir in addition to Standard Of Care Peginterferon + Ribavirin if they show a Rapid Viral Responds at week 4.
The primary hypothesis of this study is that the subset of patients with a Rapid Viral Responds after 4 weeks of triple therapy with boceprevir, peginterferon alpha-2b (P) and ribavirin (RVR4) can be successfully treated with a shorter 12-week triple therapy regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Boceprevir, peginterferon ribavirin | Experimental | All patients were intended to be treated in the 12 week peginterferon, ribavirin and boceprevir arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boceprevir | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Viral Response(SVR) 12 Weeks of Follow up After the End of All Therapy for the Rapid Viral Response at Week 4(RVR4) Population. | The outcome is a number of the patients with an undetectable Hepatitis C Virus (HCV) RNA at week 4 that have an undetectable HCV RNA 12 weeks after end of treatment. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| SVR 12 Weeks After the End of All Therapy in the Entire Study Population (With or Without RVR4). | The outcome is a number of all patients who started treatment having an undetectable HCV RNA 12 weeks after the end of therapy | 12 weeks |
| SVR 12 Weeks After End of Therapy in Patients With Already a RVR at Week 1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bart Rijnders, MD, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC | Rotterdam | South Holland | 3000CA | Netherlands | ||
| AMC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36146760 | Derived | Popping S, Cuypers L, Claassen MAA, van den Berk GE, De Weggheleire A, Arends JE, Boerekamps A, Molenkamp R, Koopmans MPG, Verbon A, Boucher CAB, Rijnders B, van de Vijver DAMC. Persistent Transmission of HCV among Men Who Have Sex with Men despite Widespread Screening and Treatment with Direct-Acting Antivirals. Viruses. 2022 Sep 2;14(9):1953. doi: 10.3390/v14091953. | |
| 26689767 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Boceprevir | 12 week Boceprevir, Peginterferon and Ribavirin in RVR4 group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Boceprevir/Peginterferon/Ribavirin | Boceprevir with Peginterferon and Ribavirin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Sustained Viral Response(SVR) 12 Weeks of Follow up After the End of All Therapy for the Rapid Viral Response at Week 4(RVR4) Population. | The outcome is a number of the patients with an undetectable Hepatitis C Virus (HCV) RNA at week 4 that have an undetectable HCV RNA 12 weeks after end of treatment. | 41 patients had a RVR4 | Posted | Number | participants | 12 weeks |
|
|
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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 | Boceprevir | 12 week Boceprevir, Peginterferon and Ribavirin in RVR4 group |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | One myocardial infarction in a patient with a high-grade left anterior descending artery stenosis that was stented uneventfully (hemoglobin (Hb) 8∙7 mmol/L at the time of the infarction). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Grade 1 anemia was observed in 83% |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| B.J.A.Rijnders | Erasmus MC | 0031107034529 | b.rijnders@erasmusmc.nl |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C512204 | N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide |
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| OTHER |
| Maastricht University Medical Center | OTHER |
| Rijnstate Hospital | OTHER |
| Slotervaart Hospital | OTHER |
| Radboud University Medical Center | OTHER |
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The number of patients who were undetectable for HCV at week one that had an undetectable HCV RNA load 12 weeks after the end of treatment |
| 12 weeks |
| SVR 12 Weeks After End of Therapy in Patients That Started Therapy ≤12weeks After the Presumed HCV Infection Date Versus Those After 12 Weeks. | The number of patients having a undetectable HCV RNA 12 weeks after the end of treatment in the group patients that was treated within 12 week of calculated transmission date. | 12 weeks |
| Alterations of Biomarkers by Therapy Induced Viral Eradication: Viral Sequencing, Mutation Analysis, Gene Expression Analysis, and RNA Analysis. | 72 weeks |
| Safety: Treatment Related (Serious) Adverse Events ((S)AE) and Treatment Discontinuation for (S)AE. | only serious adverse events are recorded in this secondary endpoint | 72 weeks |
| Amsterdam |
| Netherlands |
| OLVG | Amsterdam | Netherlands |
| Slotervaart | Amsterdam | Netherlands |
| Ziekenhuis Rijnstate | Arnhem | Netherlands |
| UMCG | Groningen | Netherlands |
| MUMC | Maastricht | Netherlands |
| Radboud UMCN | Nijmegen | Netherlands |
| UMCU | Utrecht | Netherlands |
| Hullegie SJ, Claassen MA, van den Berk GE, van der Meer JT, Posthouwer D, Lauw FN, Leyten EM, Koopmans PP, Richter C, van Eeden A, Bierman WF, Newsum AM, Arends JE, Rijnders BJ. Boceprevir, peginterferon and ribavirin for acute hepatitis C in HIV infected patients. J Hepatol. 2016 Apr;64(4):807-12. doi: 10.1016/j.jhep.2015.12.004. Epub 2015 Dec 12. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | SVR 12 Weeks After the End of All Therapy in the Entire Study Population (With or Without RVR4). | The outcome is a number of all patients who started treatment having an undetectable HCV RNA 12 weeks after the end of therapy | Total intention to treat population | Posted | Number | participants | 12 weeks |
|
|
|
| Secondary | SVR 12 Weeks After End of Therapy in Patients With Already a RVR at Week 1. | The number of patients who were undetectable for HCV at week one that had an undetectable HCV RNA load 12 weeks after the end of treatment | All patients having a rapid viral response at week 4 had a sustained viral response at 12(SVR12) weeks after treatment. | Posted | Number | participants | 12 weeks |
|
|
|
| Secondary | SVR 12 Weeks After End of Therapy in Patients That Started Therapy ≤12weeks After the Presumed HCV Infection Date Versus Those After 12 Weeks. | The number of patients having a undetectable HCV RNA 12 weeks after the end of treatment in the group patients that was treated within 12 week of calculated transmission date. | 5 patients were treated within 12 weeks after calculated transmission date. All other patients were treated between 12 and 26 weeks after calculated transmission date. | Posted | Number | participants | 12 weeks |
|
|
|
| Secondary | Alterations of Biomarkers by Therapy Induced Viral Eradication: Viral Sequencing, Mutation Analysis, Gene Expression Analysis, and RNA Analysis. | data were not collected during this study | Posted | 72 weeks |
|
|
| Secondary | Safety: Treatment Related (Serious) Adverse Events ((S)AE) and Treatment Discontinuation for (S)AE. | only serious adverse events are recorded in this secondary endpoint | 57 patients started treatment and were at risk | Posted | Number | participants | 72 weeks |
|
|
|
| 3 |
| 57 |
| 54 |
| 57 |
|
| transient ischemic attack | Vascular disorders | One suspected transient ischemic attack that resolved spontaneously and with normal MRI findings (Hb 6∙6 mmol/L) |
|
| anemia | General disorders | One anemia (Hb 5·1 mmol/L) for which a transfusion was given and the ribavirin dose was decreased. |
|
| anemia | Blood and lymphatic system disorders | grade 2 anemia was observed in 12% |
|
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D015658 | HIV Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |