IC14 in Adult Patients With Dengue Fever (NCT03875560) | Clinical Trial Compass
WithdrawnPhase 2
IC14 in Adult Patients With Dengue Fever
Stopped: withdrawn, no enrollment
0Started 2019-05
Plain-language summary
Randomized, double-blind, placebo-controlled, safety, PK/PD and preliminary efficacy study of intravenous IC14 in adult patients in a dengue-endemic region presenting with fever \> 38°C for \< 48 hours with a positive NS1 strip assay or reverse-transcriptase polymerase chain reaction assay for dengue virus.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Fever \> 38°C for \< 48 hours and clinical presentation consistent with dengue fever.
* Positive NS1 strip assay or reverse-transcriptase polymerase chain reaction (RT-PCR) assay for dengue virus.
* Informed consent form signed and dated by the patient.
* Subject able to give informed consent and able to comply with all study visits and all study procedures.
* Females of childbearing potential should be using and committed to continue using acceptable birth control methods.
* Sexual abstinence (inactivity) for 1 month prior to screening through study completion; or
* Intrauterine device (IUD) in place for at least 3 months prior to study through study completion; or
* Stable hormonal contraception for at least 3 months prior to study through study completion; or
* Surgical sterilization (vasectomy) of male partner at least 6 months prior to study.
* To be considered of non-childbearing potential, females should be surgically sterilized (bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be post-menopausal and at least 3 years since last menses.
Exclusion Criteria
* One or more of the following dengue warning signs and symptoms:
* Intense and continuous abdominal pain (referred pain or on palpation);
* Persistent vomiting;
* Fluid accumulation (ascites, pleural effusion, or pericardial effusion);
* Postural hypotension and/or collapse;
* Painful hepatomegaly \> two centimeters below…
What they're measuring
1
Incidence of treatment-emergent adverse events (safety, tolerability)