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This study is a randomized, open-label, active comparator-controlled, dose-ranging trial of the efficacy and safety of IV artesunate in combination with IV GCV or oral VGCV and SOC treatment compared to GCV or VGCV monotherapy and SOC treatment in SOT recipients with clinically significant CMV infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose Artesunate | Experimental | Low Dose Artesunate: 2.4 mg/kg IV artesunate once daily for 14 days + GCV or VGCV and SOC per local institutional practices |
|
| High Dose Artesunate | Experimental | High Dose Artesunate: 4.8 mg/kg IV artesunate once daily for 14 days + GCV or VGCV and SOC per local institutional practices |
|
| Standard Treatment Ganciclovir | Active Comparator | Standard Treatment Ganciclovir: GCV or VGCV and SOC per local institutional practices |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artesunate | Drug | Low Dose Artesunate: 2.4 mg/kg IV artesunate once daily for 14 days + GCV or VGCV and SOC per local institutional practices High Dose Artesunate: 4.8 mg/kg IV artesunate once daily for 14 days + GCV or VGCV and SOC per local institutional practices |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of cytomegalovirus (CMV) DNAemia | Determine if Artesunate for Injection (intravenous [IV] artesunate) when administered in combination with IV Ganciclovir (GCV) and/or oral valganciclovir (VGCV) and standard of care (SOC) treatment impacts change of cytomegalovirus (CMV) DNAemia compared with those who only received GCV or VGCV and SOC treatment | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Read | Contact | 240-285-9905 | Lisa.Read@amivas.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077332 | Artesunate |
| D015774 | Ganciclovir |
| ID | Term |
|---|---|
| D037621 | Artemisinins |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
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| Ganciclovir (GCV) | Drug | Standard Treatment Ganciclovir: GCV or VGCV and SOC per local institutional practices |
|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
|
| Westmead Hospital | Terminated | Westmead | Australia |
| Princess Alexandra Hospital | Terminated | Woolloongabba | Australia |
| D009930 |
| Organic Chemicals |
| D012717 | Sesquiterpenes |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |