Pharmacokinetics of the antiviral drug ribavirin in Lassa fever treatment

Prospective observational study on the pharmacokinetic properties of the Irrua ribavirin regimen used in routine clinical practice in Lassa fever patients in Nigeria

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN11104750

Enrollment

Registered

2020-02-06

Start date

2020-02-03

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lassa fever Infections and Infestations

Interventions

Pharmacokinetic analysis of ribavirin treatment Blood samples will be collected at 0.5, 1, 3, 5, 8, 12 and 24 hours after doses on day 1, day 4 and day 10 of ribavirin treatment using

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age = 18 years 2. Lassa fever confirmed by RT-PCR 3. Written informed consent 4. Anticipated treatment with intravenous ribavirin

Exclusion criteria

Exclusion criteria: 1. Inability to give consent (e.g. unconscious patients/ cognitively impaired patients) 2. Critical illness (based on investigator’s clinical evaluation) 3. Severe malnutrition 4. Hemodialysis 5. History of hemophilia / bleeding disorder 6. Hematocrit <30 % 7. History of hemoglobinopathies (i.e., sickle-cell anaemia or thalassemia major) 8. Known intolerance to ribavirin 9. Known pregnancy 10. Women who plan to get pregnant within the upcoming 3 months 11. Patients who already received ribavirin within the last 7 days

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic parameters (maximum concentration (Cmax), maximum time (Tmax), area under the curve (AUC), half-life time (T1/2), volume of distribution) using blood samples will be collected at 0.5, 1, 3, 5, 8, 12 and 24 hours after doses on day 1, day 4 and day 10 of ribavirin treatment using the Irrua dosing regimen	—

Secondary

Measure	Time frame
1. Safety and tolerability of the Irrua Ribavirin regimen measured using clinical, hematological, and biochemical parameters: 1.1. Clinical: every day from day 0 to day 10 1.2. Haematology: standarad full blood count (hb; wbc; pla; diff) every 48 hours 1.3. Biochemistry: creatinine; alt; ast; bun; ldh every 48 hours 2. Viral kinetics in patients measured using at day 0, 5, 10 3. LASV genome changes under the Irrua ribavirin regimen measured at day 0, 5, 10	—

Measure

Time frame

1. Safety and tolerability of the Irrua Ribavirin regimen measured using clinical, hematological, and biochemical parameters: 1.1. Clinical: every day from day 0 to day 10 1.2. Haematology: standarad full blood count (hb; wbc; pla; diff) every 48 hours 1.3. Biochemistry: creatinine; alt; ast; bun; ldh every 48 hours 2. Viral kinetics in patients measured using at day 0, 5, 10 3. LASV genome changes under the Irrua ribavirin regimen measured at day 0, 5, 10

—

Countries

Nigeria

Contacts

Public ContactMirjam Groger

groger@bnitm.de+49 4042818511

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026