Ribavirin for Hemorrhagic Fever With Renal Syndrome in Germany

• Status: Withdrawn
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a treatment protocol using IND Ribavirin-there is no control group. Hemorrhagic Fever with Renal Syndrome (HFRS) is caused by a virus acquired by contact with chronically infected rodent hosts. HFRS is present throughout Europe and caused mainly by Puumala and Dobrava viruses. 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 (determination if the disease is caused by Puumala or Dobrava virus is helpful) 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: U.S. Army Medical Research and Development Command; U.S. Army Medical Research and Materiel Command
• Treatments: Ribavirin

Criteria

Inclusion Criteria:

1. Meets the case definition for a probable or suspected case.

2. Has read and signed the Informed Consent.

3. Is at least 18 years of age (17, if active military) and not greater than 65 years of age.

4. Has a blood sample drawn and a type and cross-match ordered for transfusion.

5. Agrees to collection of required specimens.

6. Agrees to report any Adverse Event, Serious and Unexpected Adverse Events which may or may not be associated with administration of the drug for the duration of the study.

7. Agrees to a follow-up visit and to donate blood and urine specimens at day 10, day 14 and between days 28 and 60 after their first dose of IV Ribavirin and to all follow-up visits for anemia or other medical conditions as required by the attending physician.

8. Woman of childbearing age has a negative pregnancy test and agrees not to become pregnant during treatment and for 7 months after receiving Ribavirin. Treatment will be a maximum of 25 doses given over a one week time period. At least two reliable forms of effective contraception, including one barrier method, must be utilized during treatment and during the 7 months post-treatment period.

9. Man agrees not to have intercourse with a pregnant woman during treatment and for 7 months after receiving Ribavirin, and take precautions to avoid producing pregnancies in female partners during and for 7 months after receiving Ribavirin.

Treatment will be a maximum of 25 doses given over a one week time period. At least two reliable forms of effective contraception, including one barrier method, must be utilized during the treatment and during the 7 month post-treatment period.

10. Has a hemoglobin of 10 g/dL or higher before starting IV Ribavirin.

Exclusion Criteria:

1. Has know intolerance to Ribavirin

2. Is pregnant

3. Is irreversibly ill on presentation, as defined by presence of profound shock (shock which does not respond to supportive therapy within 3 hours after admission).

4. Has history of hemoglobinopathies (i.e., sickle-cell anemia or thalassemia major)

5. Has history of autoimmune hepatitis

6. Has a calculated serum creatinine clearance of < 20 mL/min

7. Has hemoglobin less than 10 g/dL that cannot be corrected to 10 g/dL before initiation of IV Ribavirin.

8. Is considered as New York Heart Association Cardiac functional capacity of Class II or greater for ASHD and CHF.

9. Has known cardiac conduction defects that may predispose to arrhythmias such as Wolfe-Parkinson-White Syndrome (WPW); or a history of bradyarrhythmias such as sick sinus syndrome or second degree heart block and no pacemaker.

10. Has 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). If an individual develops heart rate of less than 35 beats per minute while on IV Ribavirin, the IV Ribavirin may be discontinued by the physician.

11. Is currently being treated with Didanosine (ddI). DdI must be discontinued before starting IV Ribavirin.

Relative exclusion criteria:

1. History of gout or tophaceous gout

2. Use of drugs known to result in bradyarrhythmias (certain betablockers and calcium channel blockers)

3. Creatinine clearance of 20 to 30 mL/min