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Pharmacokinetics of Sofosbuvir/Daclatasvir in HCV-infected Lactating Women

NCT04852614 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2022-08-23

No results posted yet for this study

Summary

This is a prospective, observational, open-label, pharmacokinetic study will evaluate PK of SOF/DAC in lactating HCV-infected females at weaning or women who voluntarily decided to forego breastfeeding to initiate HCV infection treatment. Therefore, drug concentrations can be determined in maternal plasma and milk without risk to the children. HCV infected women at weaning after various durations of breastfeeding and HCV infected women who wish to initiate treatment immediately after delivery and forego breastfeeding will be recruited to start treatment under the guidance of their physician with SOF/DAC to determine M/P ratios of each of SOF, GS-331007 and DAC.

Conditions

  • Hepatitis C Virus Infection

Interventions

DIAGNOSTIC_TEST

Pharmacokinetic test

Blood samples will be collected 48 hours after the first dose on day 3 of the observed intake of the study medication at the following time points: t=0 (pre-dose), 1, 2, 3, 4, 8 and 12 hours post ingestion (7 samples) (3 mL each), Breast milk samples will be collected by emptying both breasts at 0, 2, 4, 8 and 12 hours (5 samples).

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Manal SE El-Sayed, M.D · Ain Shams University, Faculty of Medicine

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2023-11-01
Completion
2023-12-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04852614 on ClinicalTrials.gov