IC14 in Adult Patients With Dengue Fever

• Status: Withdrawn
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Implicit Bioscience

Criteria

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.