The Pathogenesis of Hepatitis C Virus Vertical Transmission

Hepatitis C Clinical Trial

Official title:

The Pathogenesis of Hepatitis C Virus Vertical Transmission

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01921400
• Other study ID #: 13-0958
• Status: Completed
• First received: August 8, 2013
• Last updated: April 5, 2018
• Start date: January 2013
• Est. completion date: December 2017

Study information

• Verified date: April 2018
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnant women with HCV infection

• Pregnant women without HCV infection

Exclusion Criteria:

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Infection Transmission, Maternal-Fetal

Locations

Country	Name	City	State
Egypt	Cairo University	Giza
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Cairo University, Merck Sharp & Dohme Corp., University of Maryland

Countries where clinical trial is conducted

United States,  Egypt, 

References & Publications (1)

Jhaveri R, Hashem M, El-Kamary SS, Saleh DA, Sharaf SA, El-Mougy F, Abdelsalam L, Ehab M, El-Ghazaly H. Hepatitis C Virus (HCV) Vertical Transmission in 12-Month-Old Infants Born to HCV-Infected Women and Assessment of Maternal Risk Factors. Open Forum In — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	1 year