An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother's and Baby's Health

Conditions

• Chagas Disease

Eligibility Criteria

Sex

FEMALE

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Nifurtimox (BAYA2502) — DRUG
  At least 1 dose of nifurtimox

Study Details

This is an observational study in which data from women with Chagas disease who will take or have already taken nifurtimox during pregnancy and the impact on their babies are studied. Chagas disease is an inflammatory, infectious disease caused by the parasite Trypanosoma cruzi. This parasite is mainly spread by insects called triatomine bug. If Chagas disease is left untreated, it can later cause e.g. serious heart and digestive problems. Nifurtimox has been used for more than 50 years to treat Chagas disease in children and adults. It is not recommended to be used during pregnancy as data from animal studies indicate that it may harm the baby. Currently, there are not enough data to know if this is also the case in humans. In this study, researchers want to collect data on the safety of nifurtimox use in pregnant women. To do this, researchers will collect the following information: * Birth defects (abnormal and problematic structures or functions, a child is born with) * Pregnancy outcomes (like live birth, preterm birth, still birth/death of the unborn baby, miscarriage, or abortion) * Certain health problems of the child up to 12 months of age * Certain health problems of the women experienced during pregnancy The data will be collected from different sources including telephone calls with the women or their doctor, CRFs (case reprt forms) or from medical records The researchers will compare the proportion of children with birth defects, pregnancy outcomes or certain health problems of the child or the women during pregnancy with available data on these outcomes in the general population. The study will run for approximately 10 years.

Key Dates

Start date

Jun 30, 2026

Status verified

May 2026

Primary completion

Jan 31, 2032

Completion

Jan 31, 2032

Study Design

Enrollment

50 participants (estimated)

Arms

• Arm: Pregnant women exposed to nifurtimox
  The study will examine the effects of nifurtimox on fetuses, neonates and infants through 12 months of age who were exposed to nifurtimox in utero and maternal complications of pregnancy in women who were exposed to at least one dose of nifurtimox during pregnancy.

Primary Outcome Measure

Major Congenital Malformations (birth defects) [ Time Frame: Up to pregnancy week 40 ]

Central Contacts

• Bayer Clinical Trials Contact
  (+)1-888-84 22937
  [email protected]

Locations (1)

Find similar trials in Multiple Locations, WV

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