PER-083-20尚未招募未知
A PHASE 2, PARTIALLY-BLINDED, RANDOMIZED, COMPARATIVE STUDY OF THE EFFICACY OF DIFFERENT DOSES OF OXFENDAZOLE COMPARED TO A SINGLE DOSE OF ALBENDAZOLE FOR THE TREATMENT OF TRICHURIS TRICHIURA INFECTION IN ADULTS
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
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
入选标准
- •1.Male or female aged 18-65 years, inclusive
- •2.Are willing to participate in this trial, as evidenced by written or witnessed oral informed consent
- •3.T. trichiura* is demonstrated in a stool sample obtained within 14 days before randomization and enrollment
- •*The presence of A. lumbricoides, N. americanus, A. duodenalis, or other helminths will not be a cause for exclusion.
- •4.Are willing to comply with the requirements of this protocol, particularly to provide four stool samples and two blood samples* over approximately 4- 6 weeks.
- •*An extra stool or blood sample might be required if the samples are not collected within the appropriate time frame or to follow up on abnormal laboratory tests.
- •5.Females of reproductive potential must have a negative serum pregnancy test within 10 days or a negative urine pregnancy test within 72 hours of the first study drug administration.*
- •*If a woman of child bearing potential is on an injectable form of contraception, a single serum pregnancy test at screening (Days -10 to -3) is acceptable. If the woman is not using an injectable form of contraception, a pregnancy test must be negative within 72 hours of the first study drug administration.
- •6.Female subjects of childbearing potential must be using effective contraception*
- •*Effective methods of contraception include: abstinence from sexual intercourse, monogamous relationship with a vasectomized partner, male condoms with spermicide, surgical sterility, intrauterine contraceptive device, oral or injectable contraceptives, diaphragm in combination with contraceptive cream or foam. Females aged ≥50 years who have had no menstrual periods for 1 year may be enrolled. Females must agree to continue effective contraception for approximately 28 days following the last study drug administration.
排除标准
- •1.Has demonstrated a previous hypersensitivity reaction to oxfendazole or a related compound (e.g. albendazole, mebendazole)
- •2.Has a diarrheal disease that would interfere with the evaluation of stool samples*
- •* more than 6 stools per day or stools that are completely liquid
- •3.Has received an antihelminthic within 14 days before enrolment
- •4.Has received an investigational drug within 30 days before the screening visit or is scheduled to receive such a drug during this trial
- •5.Has a concomitant infection or another underlying disease that would compromise the safety, diagnosis, and evaluation of responses to the study drug
- •6.Has a known history of renal dysfunction or plasma creatinine ≥1.5 times the upper limit of normal (ULN) for age
- •7.Has a known history of hepatic dysfunction or AST, ALT, total bilirubin ≥1.5 times the ULN
- •8.Has a hemoglobin that is less than 8 g/dL.
- •9.Is a female who is pregnant, lactating, or planning a pregnancy during this trial (up to days 28 after the last scheduled dose),
- •10.Has previously been enrolled in this trial
- •11.Has any condition that would, in the investigator’s opinion, interfere with this trial
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