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Study of Hepatitis C Treatment During Pregnancy

NCT02683005 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2020-03-04

No results posted yet for this study

Summary

Sofosbuvir and ledipasvir (LDV/SOF) are new directly acting antiviral drugs for the treatment of hepatitis C (HCV) that are highly effective, orally administered, well tolerated and preclinical evaluations in animal models indicate safe administration during pregnancy. This project will evaluate the safety and pharmacokinetics of antenatal LDV/SOF treatment for 12 weeks during the second and third trimester. If proven to be effective, antenatal treatment of HCV with LDV/SOF will prevent maternal HCV-related liver disease, perinatal transmission of HCV, and community transmission of HCV.

Conditions

  • Hepatitis C
  • Pregnancy

Interventions

DRUG

ledipasvir/sofosbuvir

Hepatitis C treatment with ledipasvir and sofosbuvir will be initiated during pregnancy at approximately 24 weeks of gestation.

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • University of Nebraska

    collaborator OTHER

  • Catherine Chappell

    lead OTHER

Principal Investigators

  • Catherine A Chappell, MD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2020-02-03
Completion
2020-02-03

Countries

  • United States

Study Locations

More Related Trials

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 NCT02683005 on ClinicalTrials.gov