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Stopped: withdrawn, no enrollment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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of treatment-emergent adverse events (safety, tolerability)