Hemorrhagic Fever With Renal SyndromePhase 2NCT00623168
Ribavirin for Hemorrhagic Fever With Renal Syndrome
A Phase 2 study testing Ribavirin in people with Hemorrhagic Fever With Renal Syndrome, run by U.S. Army Medical Research and Development Command at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 65 years
- Conditions the study is for
- Hemorrhagic Fever With Renal Syndrome
- What is being tested?
- Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2008to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Relative Exclusion Criteria: PI's discretion to use IND Ribavirin with caution. The PI should make the decision concerning enrollment of subjects with relative exclusion criteria based on risk versus benefit of the drug.
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Brian Allgood Army Community Hospital (121st Combat Support)
Seoul
About this study
Official title: A Phase 2 Treatment Protocol of Intravenous Ribavirin in Adult Subjects With Hemorrhagic Fever With Renal Syndrome (HFRS) in the 121st Combat Support Hospital (Seoul, Korea)
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.
Read the detailed description
Hemorrhagic Fever with Renal Syndrome (HFRS) is caused by viruses in the genus Hantavirus of the family Bunyaviridae. There are four known Hantavirus that cause HFRS: Hantaan, Seoul, Puumala and Dobrava viruses. HFRS is acquired by contact with chronically infected rodent hosts, most commonly from inhalation of infected rodent excreta. Hemorrhagic fever with renal syndrome is characterized clinically by the triad of fever, hemorrhage and renal insufficiency. HFRS typically consists of five consecutive but frequently overlapping clinical phases: febrile, hypotensive, oliguric, diuretic and convalescent. DoD operations have resulted in the deployment of personnel in Europe and Southeast Asia, areas endemic for HFRS, a viral hemorrhagic fever. Early initiation of therapy with intravenous Ribavirin has been shown to be an effective treatment for HFRS. It is therefore important to initiate therapy based on a clinical diagnosis consistent with viral hemorrhagic fever and with an epidemiological history for risk of exposure to the hantavirus. Ribavirin is a nucleoside (guanosine) analog with activity against a wide variety ribonucleic acid and deoxyribonucleic acid viruses. Mechanism of action is not fully defined. The mechanism may be related to alteration of cellular nucleotide pools and of viral messenger RNA formation, but recent data suggest the mechanism of Ribavirin in HFRS may be to serve as a RNA virus mutagen resulting in an "extinction catastrophe" error, as a result of incorporation in the viral RNA genome.
Ribavirin is licensed in the United States in aerosol form for the treatment of severe lower respiratory tract infection in children and in the oral formulation in combination with recombinant interferon alpha for the treatment of chronic hepatitis C infection. The intravenous formulation of ribavirin in not licensed in the United States. IV Ribavirin for the treatment of HFRS is used under IND 16,666.
This is a Phase 2, open-label study of the safety of IV Ribavirin treatment in individuals with Hemorrhagic Fever with Renal Syndrome (HFRS) admitted to the 121st Combat Support Hospital, Seoul, Republic of Korea. The study will also monitor morbidity and mortality of subjects with HFRS who are treated with IV Ribavirin. The study population will include all subjects with a probable or suspected clinical diagnosis of HFRS, at least 18 years of age (age 17 if active military) but not greater than 65 years of age. The Investigators intend to treat all individuals who present with a tentative diagnosis of HFRS (and within 7 days of onset of illness) and meet entry criteria with a 7 day course of IV Ribavirin and a 28-60 day follow up period after first dose of Ribavirin. In addition to treatment with Ribavirin, all subjects will be given standard supportive and symptomatic care as determined by the clinical judgment of attending physicians or consultants who manage the subject's care at the 121 CSH. Up to 50 subjects could potentially be enrolled in a five year time period with an expected accrual of 0-5 subjects per year, but the number may be higher (10 to 20 persons in a year) if an HFRS outbreak should occur. Specific inclusion/exclusion/relative exclusion criteria are a part of the protocol. Safety procedures required during 7 days of treatment include continuous cardiac monitoring, daily lab work, physical exams and vital signs.
- Conditions
- Hemorrhagic Fever With Renal Syndrome
- Being tested
- Ribavirin
- Keywords
- Ribavirin, Hemorrhagic Fever with Renal Syndrome
- Medical subject headings
- Hemorrhagic Fever with Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibavirinDrug
7 Day multiple dosing regime based on weight and dosage day
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number clinical events that occur with HFRS including oliguria, dialysis requirement, cardiac arrhythmias, and severe hemorrhage
Measured: 5 years
Number of mortalities
Measured: 5 years
Secondary outcomes (1)
Number and nature of adverse events
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2019
- Study completionDec 2019
Why it stopped: This was an expanded access treatment protocol that did not enroll any subjects due to no infections requiring treatment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhagic Fever With Renal SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Laura M Cashin, DO, Principal investigator, Brian Allgood Army Community Hospital (121st Combat Support), Seoul, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623168
- Sponsor's protocol ID
- A-14474
- Other IDs
- TAMC HUC 23H07
- Status last verified
- Jun 2025
- First submitted
- 13 Feb 2008
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Treatment Protocol of Intravenous Ribavirin in Adult Subjects With Hemorrhagic Fever With Renal Syndrome (HFRS) in the 121st Combat Support Hospital (Seoul, Korea)
- ClinicalTrials.gov ID
- NCT00623168
- Acronym / sponsor ID
- A-14474
- Conditions
- Hemorrhagic Fever With Renal Syndrome
- Keywords
- Ribavirin, Hemorrhagic Fever with Renal Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This was an expanded access treatment protocol that did not enroll any subjects due to no infections requiring treatment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Study start
- Feb 2008 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 25 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hemorrhagic Fever with Renal Syndrome (HFRS) is caused by viruses in the genus Hantavirus of the family Bunyaviridae. There are four known Hantavirus that cause HFRS: Hantaan, Seoul, Puumala and Dobrava viruses. HFRS is acquired by contact with chronically infected rodent hosts, most commonly from inhalation of infected rodent excreta. Hemorrhagic fever with renal syndrome is characterized clinically by the triad of fever, hemorrhage and renal insufficiency. HFRS typically consists of five consecutive but frequently overlapping clinical phases: febrile, hypotensive, oliguric, diuretic and convalescent. DoD operations have resulted in the deployment of personnel in Europe and Southeast Asia, areas endemic for HFRS, a viral hemorrhagic fever. Early initiation of therapy with intravenous Ribavirin has been shown to be an effective treatment for HFRS. It is therefore important to initiate therapy based on a clinical diagnosis consistent with viral hemorrhagic fever and with an epidemiological history for risk of exposure to the hantavirus. Ribavirin is a nucleoside (guanosine) analog with activity against a wide variety ribonucleic acid and deoxyribonucleic acid viruses. Mechanism of action is not fully defined. The mechanism may be related to alteration of cellular nucleotide pools and of viral messenger RNA formation, but recent data suggest the mechanism of Ribavirin in HFRS may be to serve as a RNA virus mutagen resulting in an "extinction catastrophe" error, as a result of incorporation in the viral RNA genome.
Ribavirin is licensed in the United States in aerosol form for the treatment of severe lower respiratory tract infection in children and in the oral formulation in combination with recombinant interferon alpha for the treatment of chronic hepatitis C infection. The intravenous formulation of ribavirin in not licensed in the United States. IV Ribavirin for the treatment of HFRS is used under IND 16,666.
This is a Phase 2, open-label study of the safety of IV Ribavirin treatment in individuals with Hemorrhagic Fever with Renal Syndrome (HFRS) admitted to the 121st Combat Support Hospital, Seoul, Republic of Korea. The study will also monitor morbidity and mortality of subjects with HFRS who are treated with IV Ribavirin. The study population will include all subjects with a probable or suspected clinical diagnosis of HFRS, at least 18 years of age (age 17 if active military) but not greater than 65 years of age. The Investigators intend to treat all individuals who present with a tentative diagnosis of HFRS (and within 7 days of onset of illness) and meet entry criteria with a 7 day course of IV Ribavirin and a 28-60 day follow up period after first dose of Ribavirin. In addition to treatment with Ribavirin, all subjects will be given standard supportive and symptomatic care as determined by the clinical judgment of attending physicians or consultants who manage the subject's care at the 121 CSH. Up to 50 subjects could potentially be enrolled in a five year time period with an expected accrual of 0-5 subjects per year, but the number may be higher (10 to 20 persons in a year) if an HFRS outbreak should occur. Specific inclusion/exclusion/relative exclusion criteria are a part of the protocol. Safety procedures required during 7 days of treatment include continuous cardiac monitoring, daily lab work, physical exams and vital signs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Only | Experimental | Drug: RibavirinAll consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with Ribavirin. |
Who may qualify
- Ages
- 17 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ribavirin7 Day multiple dosing regime based on weight and dosage day | Drug | Treatment Only |
Primary outcome
Number clinical events that occur with HFRS including oliguria, dialysis requirement, cardiac arrhythmias, and severe hemorrhage
Time frame: 5 years
Number of mortalities
Time frame: 5 years
1 secondary outcome
Number and nature of adverse events
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura M Cashin, DO principal investigator
Brian Allgood Army Community Hospital (121st Combat Support), Seoul, Republic of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ribavirin in people with Hemorrhagic Fever With Renal Syndrome, run by U.S. Army Medical Research and Development Command at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number clinical events that occur with HFRS including oliguria, dialysis requirement, cardiac arrhythmias, and severe hemorrhage (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.