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Transmission of Chronic Hepatitis C in Pregnancy

NCT03570112 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2024-02-08

No results posted yet for this study

Summary

This is a multicenter, non-comparative, observational study that will recruit women with singleton pregnancy and chronic HCV infection to determine the natural history of chronic HCV in pregnancy and the rate of vertical transmission to their infants. All participants will be offered curative therapy with sofosbuvir/velpatasvir (Epclusa ®) after delivery and the cessation of breastfeeding. Subjects may be enrolled at any time after conception up through 36 weeks gestation. The management of subjects in pregnancy will be in accordance with ACOG guidelines and individual clinical judgment, however testing will include, but not be limited to, testing for HCV infection, HIV infection, HBV infection, HSV infection, group B Streptococcal colonization, HCV genotype, HCV viral load, as well as assessment of hepatic and renal function. Subjects will be followed on a schedule that is determined by their obstetric care providers throughout their pregnancy. Following delivery, infants will be evaluated at 12, 24 and 48 weeks of age, with testing for HCV RNA to be obtained at each evaluation. Vertical transmission is defined as two positive HCV RNA PCR tests, at least one before the 48 week infant visit, and again at the 12-month follow-up infant visit.

Conditions

  • Hepatitis C
  • Pregnancy Complications
  • Vertical Disease Transmission

Interventions

DRUG

SOF/VEL- sofosbuvir 400mg and velpatasvir 100mg

sofosbuvir 400mg and velpatasvir 100mg once daily for 12 weeks

Sponsors & Collaborators

Principal Investigators

  • John Cafardi, MD · The Christ Hospital

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-08
Primary Completion
2022-11-22
Completion
2023-02-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT03570112 on ClinicalTrials.gov