Status:
WITHDRAWN
IC14 in Adult Patients With Dengue Fever
Lead Sponsor:
Implicit Bioscience
Conditions:
Dengue Fever
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 hour...
Detailed Description
The study will be conducted in two parts and will include an open label phase of a single dose of IC14 (Part A) and a randomized phase of multiple doses of IC14 and placebo (Part B). Up to 52 patients...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03875560
Start Date
May 1 2019
End Date
June 1 2020
Last Update
March 14 2019
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