WithdrawnPhase 2

Ribavirin for Hemorrhagic Fever With Renal Syndrome

Stopped: This was an expanded access treatment protocol that did not enroll any subjects due to no infections requiring treatment.

South Korea0Started 2008-02

Plain-language summary

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.

Who can participate

Age range17 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Have read and signed the Informed Consent (see Exception for Emergency Treatment, Section 12.0). * Are at least 18 years of age (17, if active military) and not greater than 65 years of age. * Meet the case definition for a probable or suspected case (see Section 5.0). * Have a blood sample drawn and a type and cross-match ordered for transfusion. * Agree to collection of required specimens. * Agree to report any Adverse Events, Serious and Unexpected Adverse Events for the duration of the study. * Agree to a follow-up visit and to donate blood and urine specimens at day 10, day 14 and between days 28 and 60 after the first dose of IV Ribavirin and to all follow-up visits for anemia or other medical conditions as required by the attending physician. * Women of childbearing age must have a negative pregnancy test and agree not to become pregnant for 7 months after receiving Ribavirin. Women will be counseled concerning the risks of IV Ribavirin. * Men agree not to have intercourse with pregnant women for 7 months after receiving Ribavirin, and take precautions to avoid producing pregnancies for 7 months after receiving Ribavirin. * Have a hemoglobin greater than or equal to10 g/dL before starting IV Ribavirin. Exclusion Criteria: * A known intolerance to Ribavirin. * Are irreversibly ill on presentation, as defined by presence of profound shock, which does not respond to supportive therapy within 3 hours after admission. * A positive pregnancy test. * …

What they're measuring

Number clinical events that occur with HFRS including oliguria, dialysis requirement, cardiac arrhythmias, and severe hemorrhage

Timeframe: 5 years

Number of mortalities

Timeframe: 5 years

Trial details

NCT IDNCT00623168

SponsorU.S. Army Medical Research and Development Command

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2019-12