Status:
COMPLETED
A Pharmacokinetics Study of Favipiravir in Patients With Severe Influenza
Lead Sponsor:
Capital Medical University
Collaborating Sponsors:
Beijing Institute of Pharmacology and Toxicology
University of Oxford
Conditions:
Influenza, Human
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Title: An adaptive study of the pharmacokinetics of favipiravir in patients with severe influenza Study Design: An open label, single group assignment, adaptive study to evaluate the pharmacokinetics ...
Eligibility Criteria
Inclusion
- Hospitalized males or females with a positive PCR test for influenza virus infection
- Adults aged ≥18years
- PaO2/FiO2≤300mmHg or on mechanical ventilation
- \< 10 days since symptom onset
- Negative pregnancy testing for childbearing age females (under 60 years)
- Willingness to use contraception for 7 days after end of treatment
- Informed consent
- In addition, male subjects must:
- Agree not to donate sperm during the study and for 7 days following the last dose of study drug, and
- Agree to adhere strictly to one of the following contraceptive measures from the Screening Visit until 7 days after the last dose of study drug:
- i. abstain from sexual intercourse or ii. have a female partner using effective means of birth control as noted below or iii. use a condom with spermicide or a second barrier method by female partner.
- Female subjects
- a. Of child-bearing potential must agree to adhere strictly to one of the following approved contraceptive measures during the study and for 7 days after the last dose of study drug: i. abstain from sexual intercourse or ii. have a male partner incapable of fathering a child (eg, had a vasectomy at least 6 months with history of negative semen analysis prior Screening or iii. use of one of the following methods, in combination with condom and spermicide use by a male partner: nonhormonal intrauterine device (IUD); diaphragm; or hormonal contraceptives including oral contraceptives, injectable subdermal implants, hormonal IUD, or vaginal ring b. Be unable to bear children defined as one of the following: i. absence of a menstrual period for ≥12 consecutive months with FSH confirmation, ii. be 60 years of age or greater, iii. had surgical removal of uterus or removal of both ovaries, or iv. had undergone tubal ligation \>6 weeks prior to Day 1 dosing
Exclusion
- Any condition that does not allow for safely following the protocol
- Patient refusal to accept invasive organ support treatment if needed
- Pregnant or breastfeeding
- Any condition resulted to reception of renal replacement therapy
- AST \> 5 times upper of limit or Child Pugh score ≥ C
- Serum uric acid level \> 3 times upper level of normal (430 ummol/L) associated with symptoms of gout
- Has a history of gout or is under treatment for: gout or hyperuricemia; hereditary xanthinuria; hypouricemia or xanthine calculi of the urinary tract
- Has a history of hypersensitivity to an anti-viral nucleoside-analog drug targeting a viral RNA polymerase
- Physician makes a decision that trial involvement is not in patients' best interest.
- Currently or have been involved in another anti-influenza treatment trial in the last 28 days
Key Trial Info
Start Date :
February 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2019
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03394209
Start Date
February 6 2018
End Date
March 27 2019
Last Update
May 15 2019
Active Locations (1)
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1
China-Japan Friendship Hospital
Beijing, China, 100029