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Dengue drug trial pulled before it even started
NCT ID NCT03875560
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to test a drug called IC14 in adults with early dengue fever to see if it is safe and could help reduce symptoms and viral levels. It was designed for people in areas where dengue is common, but the trial was withdrawn before any participants were enrolled. No results are available.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Expected to start
-
May 2019
An estimate. Start dates often move.
- Expected to finish
-
Jun 2020
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 the right costal margin; * Mucosal bleeding; * Major bleeding (hematemesis and/or melena); * Lethargy and/or irritability; * Diminished urine output; * Hypothermia; * Progressive increase in hematocrit or 20% above baseline or normal for age; * Abrupt drop in platelets; * Respiratory discomfort. * One or more of the following signs and symptoms of severe dengue, such as: * Severe plasma extravasation, leading to shock evidenced by one or more of the following: * Tachycardia; * Cold distal extremities; * Weak, thready pulse; * Slow capillary refill (\> 2 seconds); * Pulse pressure \< 20 mmHg; * Tachypnea; or * Oliguria (\<1.5 mL/kg/hr). * Systolic blood pressure \< 90 mmHg or decrease \>40 mmHg; * Cyanosis; * Fluid accumulation with respiratory discomfort; * Severe bleeding; or * Severe organ impairment, evidenced by one or more of the following: * Liver impairment (AST \>1000 U/L, international normalized ratio \>1.5); * Renal impairment (serum creatinine ≥1.5 mg/dL); or * Myocarditis, pericarditis, or clinical heart failure (by chest x-ray, echocardiography, electrocardiogram, or cardiac enzymes if available). * Female who is pregnant, lactating or of childbearing potential. * Self-reported or suspected congenital or acquired immunodeficiency (including HIV infection); or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the previous 3 months). * Prior vaccination against dengue fever. * Significant chronic illness that, in the opinion of the Investigator, would interfere with study validity, conduct or completion.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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Other studies related to the condition(s) this trial covers.
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