SchistosomiasisPhase 1NCT01288872
Praziquantel-Pharmacokinetic Study
A Phase 1 study testing Praziquantel in people with Schistosomiasis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Philippines.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Schistosomiasis
- What is being tested?
- Praziquantel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 sitePhilippines
- Study dates
- Jan 2012to Aug 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Screening:
- Woman must be age 18 or over.
- Present to a study midwife or health center.
- Live in a study village.
- Infected with Schistosomiasis (S.) japonicum.
- Age 18 or older.
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- Participant is otherwise healthy as determined by history, physical exam, ultrasound (if pregnant) and laboratory assessment, with the exception of laboratory values cited in Exclusion Criteria.
- Early pregnancy cohort: pregnant, between 12-16 weeks gestation.
- Late pregnancy cohort: pregnant, between 30-36 weeks gestation
- Lactating nonpregnant: 5-7 months postpartum inclusive (up to 7 months and 31 days) with negative pregnancy test.
- Ability to provide informed consent to participate.
Who cannot join
- Presence of significant disease/illness that is either acute or chronic. This will be defined by history, physical examination, ultrasound (if pregnant) and laboratory assessment. In particular:
- History of seizures or other neurologic disorder, chronic medical problem determined by history or physical examination, e.g., active hepatitis, renal disease, tuberculosis, heart disease.
- Grade 3 or higher laboratory abnormality of blood urea nitrogen (BUN), creatinine, bilirubin, white blood cell count, or platelet count will warrant exclusion. Grade 2 or higher abnormality of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) will warrant exclusion. For hemoglobin, women with severe anemia defined as hemoglobin less than 7.0 g/dL will be excluded.
- If pregnant, with myoma on ultrasound that are sub-mucosal OR women with myoma that are in any location and greater than 5 cm in size.
- If pregnant, with congenital anomalies of the reproductive tract that would be expected to cause decreased fetal weight or greatly increase the risk of pre-maturity such as duplicate uterus, uterine septum.
- For less clear cases, we will define significant illness as one that significantly alters a woman's ability to perform activities of daily living, causes symptoms at least two days per week, or necessitates regular use of medication. In the case of acute medical conditions, such as urinary tract infection, pneumonia, or febrile illness, enrollment may be postponed until the illness is successfully treated (not currently on any medication for the illness).
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- For lactating postpartum subjects: milk supply suspected to be marginal so that 24 hour interruption of nursing likely to lead to inability to restart breast feeding, evidence of breast infection, or history of breast surgery.
- Presence of cysts in the eye suggestive of neurocysticercosis.
- Regular use of a medication for a chronic medical condition.
- History of severe allergic reaction (anaphylaxis, facial swelling, or difficulty breathing) or seizure with praziquantel administration.
- If pregnant, fetus has congenital anomaly determined by ultrasound or is determined to be nonviable e.g., blighted ovum.
- Twin or higher order pregnancy.
- Woman has been enrolled into this study or its companion study ("S. japonicum and pregnancy outcomes: A Randomized, Double Blind, Placebo Controlled Trial (RCT). DMID Protocol Number: 06-0039") for a previous pregnancy.
- Inability to comprehend study procedures and provide informed consent due to limited cognitive abilities or other reason, or refuses to provide informed consent.
- Subjects receiving during the previous month any of the following drugs which may interact with praziquantel (PZQ) bioavailability, metabolism and/or elimination: carbamazepine, chloroquine, cimetidine, dexamethasone, erythromycin, fosphenytoin, itraconazole, ketoconazole, phenobarbital, phenytoin, rifampin, or any protease inhibitor or non-nucleoside reverse transcriptase inhibitor.
- Subjects ingesting grapefruit juice during the previous week.
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Research Institute for Tropical Medicine - Health Compound
Muntinlupa City, National Capital Region, 1781
About this study
Official title: Praziquantel Pharmacokinetics in Pregnancy and During Lactation
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.
Read the detailed description
Schistosomiasis infects over 200 million individuals and remains a significant cause of morbidity and mortality in developing countries, despite the availability of effective pharmacologic therapy with praziquantel (PZQ). Researchers propose to conduct a phase I study of the pharmacokinetics (PK) and safety of PZQ for the treatment of Schistosomiasis (S.) japonicum among pregnant and lactating women living in the province of Leyte, The Philippines. In practice, treatment of schistosomiasis is withheld for both pregnant and lactating post partum women in the Philippines as well as other countries endemic for schistosomiasis. Without treatment, these women accrue known morbidities identified among non-pregnant subjects including hepatic fibrosis, under-nutrition, and anemia. The overall aims of this study are to see if there are differences in PZQ PK and safety during pregnancy compared to post partum, to describe the kinetics of breast milk transfer of PZQ and to estimate the dose of PZQ received by a nursing infant whose mother is treated with PZQ. This protocol will enroll 15 pregnant women in early pregnancy (12-16 weeks gestation), 15 pregnant women in late pregnancy (30-36 weeks gestation) and 15 lactating nonpregnant women between 5 and 7 months postpartum. The study population will consist of S. japonicum infected women in study villages or at the Municipal Health Centers. Women must be: age 18 or older, otherwise healthy without disease of any major organ system, without history of seizures, chronic medical problem or any neurologic disorders, without history of severe allergic reaction to PZQ and willing to provide informed consent to participate. The pregnant women must: have a singleton pregnancy, be carrying a fetus without evidence of anomaly by ultrasound. Pregnant subjects will be treated with PZQ in early pregnancy (12-16 weeks gestation) or late pregnancy (30-36 weeks gestation), lactating nonpregnant (5-7 months postpartum inclusive ). A total dose of 60 mg/kg of study medication will be provided in 2 split doses over 3 hours as this has been shown to substantially reduce drug side effects. All subjects will be hospitalized overnight for intensive blood sampling and for monitoring for adverse events. Serial breast milk samples will be collected from lactating women. Plasma and breast milk will be assayed for PZQ concentration. PK parameters in pregnant and postpartum women will be compared and kinetics of praziquantel breast milk transfer and estimation of infant PZQ dose from breast milk will be determined. Safety assessments will be performed on pregnant women and their infants through 1 month postpartum, and on postpartum women through 2 weeks post dosing. This study is linked to Division of Microbiology and Infectious Disease (DMID) protocol 06-0039.
- Conditions
- Schistosomiasis
- Being tested
- Praziquantel
- Keywords
- Praziquantal, Schistosomiasis, pregnant women, Philippines
- Medical subject headings
- Schistosomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PraziquantelDrug
Praziquantel (PZQ), 60 mg/kg, administered orally in split dose (30 mg/kg each dose) separated by three hours.
| Study group | Role | What they receive |
|---|---|---|
| Praziquantel | Experimental | 45 women in 3 cohorts (15 early pregnancy: 12-16 weeks gestation; 15 late pregnancy: 30-36 weeks gestation; and 15 lactating nonpregnant women who are 5-7 months (inclusive) postpartum) given praziquantel (PZQ), 60 mg/kg orally in split dose (30 mg/kg each) separated by 3 hours. Receives: Drug: Praziquantel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 24 hours after the first dose of PZQ
Early Pregnancy Cohort only: Assessed for the presence of pre-eclampsia.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Up to 9 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
- Study startJan 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchistosomiasisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288872
- Sponsor's protocol ID
- 08-0049
- Other IDs
- 5U01AI066050-07
- Status last verified
- Sep 2013
- First submitted
- 28 Jan 2011
- Last updated
- 18 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Praziquantel Pharmacokinetics in Pregnancy and During Lactation
- ClinicalTrials.gov ID
- NCT01288872
- Acronym / sponsor ID
- 08-0049
- Conditions
- Schistosomiasis
- Keywords
- Praziquantal, Schistosomiasis, pregnant women, Philippines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jan 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 3 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Schistosomiasis infects over 200 million individuals and remains a significant cause of morbidity and mortality in developing countries, despite the availability of effective pharmacologic therapy with praziquantel (PZQ). Researchers propose to conduct a phase I study of the pharmacokinetics (PK) and safety of PZQ for the treatment of Schistosomiasis (S.) japonicum among pregnant and lactating women living in the province of Leyte, The Philippines. In practice, treatment of schistosomiasis is withheld for both pregnant and lactating post partum women in the Philippines as well as other countries endemic for schistosomiasis. Without treatment, these women accrue known morbidities identified among non-pregnant subjects including hepatic fibrosis, under-nutrition, and anemia. The overall aims of this study are to see if there are differences in PZQ PK and safety during pregnancy compared to post partum, to describe the kinetics of breast milk transfer of PZQ and to estimate the dose of PZQ received by a nursing infant whose mother is treated with PZQ. This protocol will enroll 15 pregnant women in early pregnancy (12-16 weeks gestation), 15 pregnant women in late pregnancy (30-36 weeks gestation) and 15 lactating nonpregnant women between 5 and 7 months postpartum. The study population will consist of S. japonicum infected women in study villages or at the Municipal Health Centers. Women must be: age 18 or older, otherwise healthy without disease of any major organ system, without history of seizures, chronic medical problem or any neurologic disorders, without history of severe allergic reaction to PZQ and willing to provide informed consent to participate. The pregnant women must: have a singleton pregnancy, be carrying a fetus without evidence of anomaly by ultrasound. Pregnant subjects will be treated with PZQ in early pregnancy (12-16 weeks gestation) or late pregnancy (30-36 weeks gestation), lactating nonpregnant (5-7 months postpartum inclusive ). A total dose of 60 mg/kg of study medication will be provided in 2 split doses over 3 hours as this has been shown to substantially reduce drug side effects. All subjects will be hospitalized overnight for intensive blood sampling and for monitoring for adverse events. Serial breast milk samples will be collected from lactating women. Plasma and breast milk will be assayed for PZQ concentration. PK parameters in pregnant and postpartum women will be compared and kinetics of praziquantel breast milk transfer and estimation of infant PZQ dose from breast milk will be determined. Safety assessments will be performed on pregnant women and their infants through 1 month postpartum, and on postpartum women through 2 weeks post dosing. This study is linked to Division of Microbiology and Infectious Disease (DMID) protocol 06-0039.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Praziquantel | Experimental | Drug: Praziquantel45 women in 3 cohorts (15 early pregnancy: 12-16 weeks gestation; 15 late pregnancy: 30-36 weeks gestation; and 15 lactating nonpregnant women who are 5-7 months (inclusive) postpartum) given praziquantel (PZQ), 60 mg/kg orally in split dose (30 mg/kg each) separated by 3 hours. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Woman must be age 18 or over.
- Present to a study midwife or health center.
- Live in a study village.
- Infected with Schistosomiasis (S.) japonicum.
- Age 18 or older.
Key exclusion criteria (16 listed)
- Presence of significant disease/illness that is either acute or chronic. This will be defined by history, physical examination, ultrasound (if pregnant) and laboratory assessment. In particular:
- For lactating postpartum subjects: milk supply suspected to be marginal so that 24 hour interruption of nursing likely to lead to inability to restart breast feeding, evidence of breast infection, or history of breast surgery.
- Presence of cysts in the eye suggestive of neurocysticercosis.
- Regular use of a medication for a chronic medical condition.
- History of severe allergic reaction (anaphylaxis, facial swelling, or difficulty breathing) or seizure with praziquantel administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PraziquantelPraziquantel (PZQ), 60 mg/kg, administered orally in split dose (30 mg/kg each dose) separated by three hours. | Drug | Praziquantel |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Praziquantel in people with Schistosomiasis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2019; AzTrials last refreshed its copy on 27 Oct 2026.