Ribavirin for Hemorrhagic Fever With Renal Syndrome in Germany (HFRS)
|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Recruitment Status : Withdrawn (Lack of enrollment)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 ]
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|