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NCT03570112 · ClinicalTrials.gov registry record
Transmission of Chronic Hepatitis C in Pregnancy
A clinical trial, sponsored by The Christ Hospital.
- Completed
- Registry status
- 40
- Enrollment target
NCT03570112: Completed study, sponsored by The Christ Hospital.
NCT03570112 is a clinical trial that has completed, run by The Christ Hospital. The registered enrollment target is 40 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03570112 has completed, sponsored by The Christ Hospital.
- COMPLETED
- Registry status
- 40 participants
- Enrollment target
Study Summary
This is a multicenter, non-comparative, observational study that will recruit women with singleton pregnancy and chronic HCV infection to determine the natural history of chronic HCV in pregnancy and the rate of vertical transmission to their infants. All participants will be offered curative therapy with sofosbuvir/velpatasvir (Epclusa ®) after delivery and the cessation of breastfeeding. Subjects may be enrolled at any time after conception up through 36 weeks gestation. The management of subjects in pregnancy will be in accordance with ACOG guidelines and individual clinical judgment, however testing will include, but not be limited to, testing for HCV infection, HIV infection, HBV infection, HSV infection, group B Streptococcal colonization, HCV genotype, HCV viral load, as well as assessment of hepatic and renal function. Subjects will be followed on a schedule that is determined by their obstetric care providers throughout their pregnancy. Following delivery, infants will be evaluated at 12, 24 and 48 weeks of age, with testing for HCV RNA to be obtained at each evaluation. Vertical transmission is defined as two positive HCV RNA PCR tests, at least one before the 48 week infant visit, and again at the 12-month follow-up infant visit.
Primary Outcome
Evaluate the rate of vertical transmission in infants born to HCV infected mothers by detection of HCV RNA in the infant prior to and again at 12 months of age.
Interventions
- DRUG SOF/VEL- sofosbuvir 400mg and velpatasvir 100mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-06-08 |
| Est. Completion | 2023-02-27 |
What the finished NCT03570112 record still lists
NCT03570112 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which SOF/VEL- sofosbuvir 400mg and velpatasvir 100mg is the first listed.
NCT03570112 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03570112 about?
NCT03570112 is a clinical study titled "Transmission of Chronic Hepatitis C in Pregnancy". This is a multicenter, non-comparative, observational study that will recruit women with singleton pregnancy and chronic HCV infection to determine the natural history of chronic HCV in pregnancy and the rate of vertical transmission to their infants. All participants will be offered curative therap...
What is the current status of trial NCT03570112?
This trial is currently completed. The enrollment target is 40 participants. The study started on 2018-06-08. Estimated completion is 2023-02-27.
What interventions are being tested in trial NCT03570112?
The interventions under investigation include: SOF/VEL- sofosbuvir 400mg and velpatasvir 100mg (DRUG).
Who is sponsoring clinical trial NCT03570112?
This trial is sponsored by The Christ Hospital, which has 13 total clinical trials registered on ClinicalTrials.gov.
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