PER-109-11未知未知
AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF RESLIZUMAB (3.0 mg/kg) AS TREATMENT FOR PATIENTS WITH EOSINOPHILIC ASTHMA WHO COMPLETED A PRIOR CEPHALON-SPONSORED STUDY IN EOSINOPHILIC ASTHMA
试验速览
- 阶段
- 未知
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 75（—）
入选标准
- •(A) THE PATIENT IS MALE OR FEMALE, 12 THROUGH 75 YEARS OF AGE, WITH A PREVIOUS DIAGNOSIS OF ASTHMA. PATIENTS 12 THROUGH 17 YEARS OLD ARE EXCLUDED FROM PARTICIPATING IN INDIA AND ARGENTINA; PATIENTS 66 THROUGH 75 YEARS OF AGE ARE EXCLUDED FROM PARTICIPATING IN INDIA.
- •(B) WRITTEN INFORMED CONSENT IS OBTAINED. PATIENTS 12 THROUGH 17 YEARS OLD, WHERE PARTICIPATING, NEED TO PROVIDE ASSENT IN ACCORDANCE WITH LOCAL STANDARDS.
- •(C) PATIENT MUST HAVE COMPLETED TREATMENT IN A PREVIOUS CEPHALON-SPONSORED DOUBLE-BLIND ASTHMA EXACERBATION STUDY OR RECEIVED AT LEAST 2 DOSES OF STUDY DRUG TREATMENT IN A PULMONARY FUNCTION STUDY.
- •(D) THE PATIENT MUST BE WILLING AND ABLE TO COMPLY WITH STUDY RESTRICTIONS AND TO REMAIN AT THE CLINIC FOR THE REQUIRED DURATION DURING THE STUDY PERIOD, AND WILLING TO RETURN TO THE CLINIC FOR THE FOLLOW-UP EVALUATION AS SPECIFIED IN THIS PROTOCOL.
排除标准
- •(A) THE PATIENT HAS A CLINICALLY MEANINGFUL COMORBIDITY THAT WOULD INTERFERE WITH THE STUDY SCHEDULE OR PROCEDURES, OR COMPROMISE THE PATIENT´S SAFETY.
- •(B) THE PATIENT HAS CONFOUNDING UNDERLYING LUNG DISORDER (e.g., CHRONIC OBSTRUCTIVE PULMONARY DISEASE, PULMONARY FIBROSIS, OR LUNG CANCER).
- •(C) THE PATIENT IS CURRENT SMOKER.
- •(D) THE PATIENT IS EXPECTED TO BE POORLY COMPLIANT WITH STUDY DRUG ADMINISTRATION, STUDY PROCEDURES, OR VISITS.
- •(E) THE PATIENT HAS ANY AGGRAVATING FACTORS THAT ARE INADEQUATELY CONTROLLED (e.g., GASTROESOPHAGEAL REFLUX DISEASE [GERD]).
- •(F) FEMALE PATIENTS OF CHILDBEARING POTENTIAL (NOT SURGICALLY STERILE OR 2 YEARS POSTMENOPAUSAL), MUST USE A MEDICALLY ACCEPTED METHOD OF CONTRACEPTION AND MUST AGREE TO CONTINUE USE OF THIS METHOD FOR THE DURATION OF THE STUDY AND FOR 30 DAYS AFTER THE END-OF-TREATMENT VISIT. ACCEPTABLE METHODS OF CONTRACEPTION INCLUDE BARRIER METHOD WITH SPERMICIDE, ABSTINENCE, INTRAUTERINE DEVICE (IUD), OR STEROIDAL CONTRACEPTIVE (ORAL, TRANSDERMAL, IMPLANTED, AND INJECTED).
- •(G) THE PATIENT HAS A CURRENT INFECTION OR DISEASE THAT MAY PRECLUDE ASSESSMENT OF ASTHMA.
研究者
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