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The Pathogenesis of Hepatitis C Virus Vertical Transmission

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ClinicalTrials.gov Identifier: NCT01921400
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : April 9, 2018
Sponsor:
Collaborators:
University of Maryland, College Park
Cairo University
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief 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.


Condition or disease
Hepatitis C Infection Transmission, Maternal-Fetal

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Study Type : Observational
Actual Enrollment : 38 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Pathogenesis of Hepatitis C Virus Vertical Transmission
Study Start Date : January 2013
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort
HCV-infected mothers
in situ hybridization
Uninfected mothers
in situ hybridization



Primary Outcome Measures :
  1. 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. [ Time Frame: 1 year ]

    We will begin by examining paraffin-embedded sections from HCV-infected mothers who had the placentas sent to pathology for analysis.We will perform a combination of immunohistochemistry (IHC) and immunofluorescence (IF) to analyze the level of SPP expression in the trophoblast cell layer, as well as if HCV Core protein expression was detectable in this layer or in any cell type within the placental section.

    We would also plan to identify other patient-derived tissues that were not paraffin embedded, both from uninfected patients and infected patients to validate different parts of our preliminary data. We would plan to use dissected fetal membranes, which contain both chorion and amnion, to investigate the level of SPP expression in these tissues.



Biospecimen Retention:   Samples With DNA
Our planned protocol will be to secure whole placental organs after delivery for study patients. Tissue preparation will include a combination of segments preserved in nucleic acid preservative (TriZol or equivalent) and flash freeze of sections to preserve cellular anatomy.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women with HCV infection who present to our collaborating institution in Egypt, and at UNC
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921400


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Egypt
Cairo University
Giza, Egypt
Sponsors and Collaborators
University of North Carolina, Chapel Hill
University of Maryland, College Park
Cairo University
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Ravi Jhaveri, M.D. UNC Department of Pediatrics: Division of Allergy, Immunology, Rheumatology and Infectious Diseases

Publications of Results:
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01921400     History of Changes
Other Study ID Numbers: 13-0958
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018

Keywords provided by University of North Carolina, Chapel Hill:
Hepatitis C (HCV)
Infection Transmission, Maternal-Fetal
Placenta
Trophoblast

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections