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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019057-17 | EudraCT Number |
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The main purpose of this study is to determine the safety and tolerability of multiple dosing of miravirsen in subjects infected with chronic hepatitis C.
Secondary purpose includes assessment of pharmacokinetics of miravirsen and assessment of miravirsen's effect on HCV viral titer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| miravirsen | Experimental | Dose escalation study with review of safety data following each cohort. |
|
| saline | Placebo Comparator | Dose escalation study with review of safety data following each cohort. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| miravirsen | Drug | SC injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | Safety evaluation will study the adverse event (AE) profile, clinical laboratory safety tests, vital signs, 12 lead and ECG monitoring. | regularly over 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | Appropriate PK parameters, e.g. maximum observed plasma drug concentrations, area under the plasma concentration-time curves, the apparent terminal rate constant and corresponding half-life for miravirsen. | continuously over 4 weeks |
| Miravirsen treatment effect on viral titer |
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Inclusion Criteria:
Previous documentation of positive HCV serology (HCV antibody or HCV RNA) at least 24 weeks prior to enrollment, OR Positive HCV serology (HCV antibody or HCV RNA) with a prior remote risk factor (more than 24 weeks prior to Screening) for the acquisition of hepatitis C
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Zeuzem, MD | J.W. Goethe University Hospital, Frankfurt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alamo Medical Research | San Antonio | Texas | United States | |||
| J.W. Goethe University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25385103 | Derived | Ottosen S, Parsley TB, Yang L, Zeh K, van Doorn LJ, van der Veer E, Raney AK, Hodges MR, Patick AK. In vitro antiviral activity and preclinical and clinical resistance profile of miravirsen, a novel anti-hepatitis C virus therapeutic targeting the human factor miR-122. Antimicrob Agents Chemother. 2015 Jan;59(1):599-608. doi: 10.1128/AAC.04220-14. Epub 2014 Nov 10. | |
| 23534542 |
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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 |
|---|---|
| C581159 | miravirsen |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| saline |
| Drug |
SC injection |
|
| regularly over 18 weeks |
| Frankfurt |
| D-60590 |
| Germany |
| Academic Medical Center (AMC) | Amsterdam | 22660 1100 D | Netherlands |
| Erasmus MC University Hospital | Rotterdam | 3015 CE | Netherlands |
| Klinika Hepatologii i Nabytych Niedoborow Immunologicznych WUM | Warsaw | 01-201 | Poland |
| Fundacion de Investigation de Diego | San Juan | Puerto Rico |
| FNsP Bratislava, Nemocnica akad. | Bratislava | 833 05 | Slovakia |
| Janssen HL, Reesink HW, Lawitz EJ, Zeuzem S, Rodriguez-Torres M, Patel K, van der Meer AJ, Patick AK, Chen A, Zhou Y, Persson R, King BD, Kauppinen S, Levin AA, Hodges MR. Treatment of HCV infection by targeting microRNA. N Engl J Med. 2013 May 2;368(18):1685-94. doi: 10.1056/NEJMoa1209026. Epub 2013 Mar 27. |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D017670 |
| Sodium Compounds |