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The Pathogenesis of Hepatitis C Virus Vertical Transmission

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Completed

Conditions

Infection Transmission, Maternal-Fetal
Hepatitis C

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT01921400
13-0958

Details and patient eligibility

About

To evaluate for the presence of HCV Core protein, HCV RNA and SPP in the placenta and fetal membranes using paraffin-embedded sections and post-delivery specimens respectively. In parallel, we will assess placental tissue for evidence of HCV infection using a novel in situ hybridization technique and translate our in vitro findings to these in vivo samples.

Our overall hypothesis is that cytotrophoblasts at the maternal-fetal interface within the placenta serve as a "barrier" that must be crossed during vertical transmission and that cytotrophoblasts are permissive to HCV at a low level that may be enhanced under certain conditions. By comparing the regulation of key steps in the intracellular life cycle of HCV in cytotrophoblasts to highly permissive hepatocytes, significant differences in HCV regulation should be revealed.

Based on our preliminary data, our working hypothesis is that HCV Core protein is differentially processed in cytotrophoblasts compared to hepatocytes.

Enrollment

38 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Pregnant women with HCV infection
  • Pregnant women without HCV infection

Exclusion criteria

  • None

Trial design

38 participants in 2 patient groups

HCV-infected mothers
Description:
in situ hybridization
Uninfected mothers
Description:
in situ hybridization

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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