A Phase 2 Treatment Protocol of Intravenous Ribavirin in Adult Subjects With Hemorrhagic Fever With Renal Syndrome (HFRS) in the 121st Combat Support Hospital (Seoul, Korea)

NCT00623168 Phase 2 WITHDRAWN

Hemorrhagic Fever with Renal Syndrome (HFRS) is caused by a virus acquired by contact with chronically infected rodent hosts. HFRS is present throughout Korea. Treatment consists mainly of supportive care with careful attention to control of blood pressure and fluid balance and/or dialysis. Early initiation of IND Intravenous Ribavirin has been shown to be an effective treatment for HFRS and may prevent the need for dialysis. It is important to initiate therapy based on a diagnosis consistent with HFRS and a history that makes exposure likely. This study will monitor the clinical events that occur with HFRS as well as the safety and efficacy of Ribavirin.

Details

Lead sponsor	U.S. Army Medical Research and Development Command
Phase	Phase 2
Status	WITHDRAWN
Start date	2008-02
Completion	2019-12

Conditions

• Hemorrhagic Fever With Renal Syndrome

Interventions

• Ribavirin

Primary outcomes

• Number clinical events that occur with HFRS including oliguria, dialysis requirement, cardiac arrhythmias, and severe hemorrhage — 5 years
• Number of mortalities — 5 years

Countries

South Korea