Ribavirin for Hemorrhagic Fever With Renal Syndrome in Germany (HFRS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00868946|
Recruitment Status : Withdrawn (Lack of enrollment)
First Posted : March 25, 2009
Last Update Posted : October 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhagic Fever With Renal Syndrome||Drug: Virazole (Ribavirin)||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Treatment Protocol of Intravenous Ribavirin in Adult Subjects With Hemorrhagic Fever With Renal Syndrome (HFRS) in Landstuhl Regional Medical Center (Landstuhl, Germany) IND 16,666|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
Experimental: Treatment with IND Ribavirin
All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with IND Virazole (Ribavirin) for 7 days with multiple dosing regime based on weight and dosage day.
Drug: Virazole (Ribavirin)
Duration of Subject Participation:7-day course of treatment with follow-up 28 - 60 days after first dose of IV ribavirin Route of Administration and Regimen:The drug is administered IV in a volume of 50-100 mL of normal saline to be infused over 30-40 minutes.
Ribavirin Loading dose, 33 mg/kg (maximum dose: 2.64 g), followed by a dose of 16 mg/kg (maximum dose: 1.28 g) every 6 hours for the first 4 days (15 doses), and 8 mg/kg (maximum dose: 0.64 g) every 8 hours for the subsequent 3 days (9 doses).
Other Name: Ribavirin
- Number of subject who develop oliguria [ Time Frame: 5 years ]Number of subject who develop oliguria (≤ 400 mL of urine in a 24-hour period), who require hemodialysis, who have cardiac arrhythmias, or who experience severe hemorrhage [results in hypotension (< 90 mm Hg systolic blood pressure) or hemorrhagic shock]. Subject mortality will be evaluated.
- Number of mortalities [ Time Frame: 5 years ]
- Number and type of adverse events for all subjects. [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00868946
|Landstuhl Regional Medical Center|
|Landstuhl, APO Ae, Germany, 09180|
|Principal Investigator:||Elizabeth Rini||Landstuhl Regional Medical Center|