NCT01288872

Praziquantel Pharmacokinetics in Pregnancy and During Lactation

Completed Phase 1 Last updated 16 January 2019

What this trial tests

Phase 1 trial testing Praziquantel in Schistosomiasis in 47 participants. Completed in 1 August 2013.

Timeline

1 January 2012

Primary endpoint
1 August 2013

1 August 2013

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	47
Start date	1 January 2012
Primary completion	1 August 2013
Estimated completion	1 August 2013
Sites	1 location across Philippines

Drugs / interventions tested

• Praziquantel — full drug profile →

Conditions studied

• Schistosomiasis — all drugs for Schistosomiasis →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 99, female only, with Schistosomiasis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Comparison of PZQ and 4-hydroxy PZQ PK parameters in pregnant and nonpregnant lactating subjects, central tendency and distribution (Cmax, Tmax, t ½, AUC, CL/F and Vd/F).
  Time frame: Up to 24 hours after the first dose of PZQ
• Early Pregnancy Cohort only: Assessed for the presence of pre-eclampsia.
  Time frame: Assessed for the presence of pre-eclampsia at both the 22 and 32 week visits.
• Pregnant women only: newborn congenital anomalies. The number of infants with congenital anomalies
  Time frame: Newborn examined by the midwife (or pediatrician if in hospital) at delivery and within 2-6 days of delivery to assess the presence of congenital anomalies and well-being. Newborn examined by study pediatrician at 28 days of life.
• Early Pregnancy Cohort only: number of subjects experiencing a spontaneous abortion and number of stillbirths reported after drug administration; and live birth rate among pregnant subjects.
  Time frame: Women will be observed in hospital for 24 hours after dosing and asked to return for any bleeding at any time.
• Toxicity to maternal bone marrow, kidney, and liver will be assessed by measurement of complete blood count, blood urea nitrogen (BUN) and creatinine, and liver function tests (AST, ALT, and bilirubin).
  Time frame: Collected just before the dose, 24 hours after the dose and at either 20 weeks after the dose (early gestation subjects) or 10-14 days after the dose (late gestation and lactating postpartum subjects).
• Subjects will be observed in hospital for adverse events/serious adverse events (AE/SAEs).
  Time frame: Up to 9 months from enrollment

Sponsor's own description

The purpose of the study is to understand whether the drug praziquantel (PZQ) is metabolized or broken down differently when women are pregnant versus not pregnant. PZQ is used to treat schistosomiasis (worm infection). Researchers will study how PZQ is broken down among 15 women who are 12-16 weeks pregnant, 15 women who are 30-36 weeks pregnant, and 15 women nonpregnant women who are producing breast milk. All women will be 18 or older and otherwise healthy. The usual practice is to wait until after mothers have finished pregnancy and breast feeding before giving PZQ. Participants will receive 2 doses of PZQ separated by 3 hours. Study procedures will include a 24 hour hospital stay following administration of PZQ, blood, stool and urine samples, ultrasound if pregnant, and physical exams of mother and baby. Patient participation for mother/infant pair is about 9 months.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.