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The Pathogenesis of Hepatitis C Virus Vertical Transmission

NCT01921400 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 38

Last updated 2018-04-09

No results posted yet for this study

Summary

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.

Conditions

  • Hepatitis C
  • Infection Transmission, Maternal-Fetal

Sponsors & Collaborators

  • University of Maryland

    collaborator OTHER

  • Cairo University

    collaborator OTHER

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Ravi Jhaveri, M.D. · UNC Department of Pediatrics: Division of Allergy, Immunology, Rheumatology and Infectious Diseases

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United States
  • 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 NCT01921400 on ClinicalTrials.gov