A PHASE 2, RAMDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF TWO DOSES OF FAVIPIRAVIR IN ADULT PATIENTS WITH UNCOMPLICATED INFLUENZA

Toyama Chemical Co., Ltd.,0 个研究点目标入组 89 人开始时间: 2011年7月21日最近更新: 2023年9月4日

研究概览

暂无简介。

•1. PATIENT HAS PROVIDED WRITTEN INFORMED CONSENT PRIOR TO PERFORMING ANY STUDY-RELATED PROCEDURES.
•2. MALE OR FEMALE PATIENTS 20-80 YEARS OLD, INCLUSIVE.
•3. PATIENTS WHO TEST POSITIVE FOR INFLUENZA A OR B BY A COMMERCIALLY AVAILABLE RAPID ANTIGEN TEST (RAT) OF THE NASOPHARYNX. A PATIENT WITH A NEGATIVE RAT RESULT MAY STIL ENROLL IF THE SPONSOR AND INVESTIGATOR AGREE THAT THERE IS A KNOWN INFLUENZA OUTBREAK CIRCULATING IN THE COMMUNITY.
•4. PATIENTS ≥ 20 BUT < 65 YEARS OLD WITH A TEMPERATURE (ORAL) OF 100.4°F (38.0°C) OR MORE; PATIENTS ≥ 65 YEARS OLD WITH A TEMPERATURE (ORAL) 100.0°F (37.8°C) OR MORE AT THE FIRST VISIT, OR IN THE 6 HOURS PRIOR IF ANTIPYRETICS WERE TAKEN.
•5. MALE PATIENTS MUST AGREE TO THE FOLLOWING:
•THEY ARE INCAPABLE OF FATHERING A CHILD (HAVE HAD A VASECTOMY AT LEAST 6 MONTHS AGO AND HAVE HAD SPERM COUNTS VERIFYING THAT THEY ARE NO LONGER FERTILE) OR
•THEY DO NOT INTEND TO FATHER A CHILD WITHIN 3 MONTHS AFTER THE LAST DOSE OF THE STUDY DRUG, IN WHICH CASE:
•. THEY MUST USE A CONDOMS DURING SEXUAL INTERCOURSE WITH A FEMALE PARTNER WHO COULD BECOME PREGNANT OR THEY MUST ABSTAIN FROM SEXUAL INTERCOURSE.

•1. FEMALE PATIENTS WHO ARE PREGNANT, BREAST-FEEDING, OR HAVE A POSITIVE URINE PREGNANCY TEST AT VISIT 1.
•2. PATIENTS WHO HAVE HAD INFLUENZA SYMPTOMS OR FEVER (ie., ONE OF THE SYMPTOMS LISTED UNDER THE INCLUSION CRITERIA) FOR 36 HOURS OR MORE PRIOR TO STUDY SCREENING.
•3. PATIENTS WHO HAVE TAKEN A ANTI-INFLUENZA DRUG (eg., AMANTADINE HYDROCHLORIDE, RIMANTADINE, OSELTAMIVIR PHOSPHATE, ZANAMIVIR HYDRATE OR PERAMIVIR) OR LIVE VACCINATION WITHIN 4 WEEKS PRIOR TO THE BEGINNING OF THE STUDY.
•4. PATIENTS WHO HAVE UNDERLYING CHRONIC RESPIRATORY DISEASE (eg., COPD, CHRONIC BRONCHITIS, DIFUSE PARBRONCHIOLITIS, BRONCHIECTASIS, PULMONARY EMPHYSEMA, PULMONARY FIBROSIS, BRONCHIAL ASTHMA, OR OLD TUBERCULOSIS).
•5. PATIENTS WHO AT THE BEGINNING OF THE STUDY ARE SUSPECTED OF HAVING BACTERIAL RESPIRATORY INFECTION (ie., EXPECTORATION OF PURULENT OR MUCOPURULENT SPUTUM AND/OR INFILTRATE IN LUNG IN A CHEST X-RAY, ETC.).
•6. PATIENTS WHO HAVE A HISTORY OF GOOT ARE UNDER TRATMENT FOR GOUT OR HYPERURICEMIA.
•7. PATIENTS WITH HEREDITARY XANTHINURIA.
•8. PATIENTS WHO HAVE A HISTORY OF HYPOURICEMIA (UNDER 1 mg/dL) OR XANTHINE CALCULI OF THE URINARY TRACT.

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