Ribavirin for Hemorrhagic Fever With Renal Syndrome

NCT00623168 | Withdrawn Phase 2

• 2 other identifiers: A-14474TAMC HUC 23H07
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemorrhagic Fever With Renal Syndrome

Keywords

Ribavirin; Hemorrhagic Fever with Renal Syndrome

Outcome Measures

Primary Outcomes (2)

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

  5 years

• Number of mortalities

  5 years

Secondary Outcomes (1)

• Number and nature of adverse events

  5 years

Study Arms (1)

Treatment Only

EXPERIMENTAL

All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with Ribavirin.

Drug: Ribavirin

Interventions

Ribavirin DRUG

7 Day multiple dosing regime based on weight and dosage day

Treatment Only

Eligibility Criteria

• Age: 17 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• An estimated creatinine clearance \< 20 ml/minute.
• A history of hemoglobinopathies (i.e., sickle-cell anemia or thalassemia major).
• A history of autoimmune hepatitis.
• A hemoglobin less than 10 g/dL that cannot be corrected to ≥10 g/dL before initiation of IV Ribavirin.
• A New York Heart Association Cardiac functional capacity of Class II or greater for ASHD and CHF.
• Known cardiac conduction defects that may predispose the subject to arrhythmias, such as second or third degree heart block or sick sinus syndrome (and no pacemaker), or Wolfe-Parkinson-White Syndrome.
• A sinus bradycardia of less than 40 beats per minute (or sinus bradycardia less than 50 beats per minute if the individual is not known to have a low resting heart rate related to physical conditioning).
• Concurrent therapy with Didanosine (ddI). DdI must be discontinued before starting the IV Ribavirin.
• Creatinine clearance is 20 - 30 mL/minute
• History of gout or tophaceous gout
• On any drug that may decrease heart rate (beta-blockers, calcium channel blockers, digoxin IV Ribavirin should be avoided in severe renal insufficiency, and its use with a creatinine clearance between 20 to 30 mL/min should be based on the risk versus benefit. If used, the drug should be discontinued if the creatinine clearance decreases to 20 mL/min or lower.

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead

Study Sites (1)

Brian Allgood Army Community Hospital (121st Combat Support)

Seoul, South Korea

Location

MeSH Terms

Conditions

Hemorrhagic Fever with Renal Syndrome

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Hantavirus Infections; Bunyaviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Hemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Laura M Cashin, DO

  Brian Allgood Army Community Hospital (121st Combat Support), Seoul, Republic of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2008
• First Posted: February 25, 2008
• Study Start: February 1, 2008
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

KR (1)