Transmission of Chronic Hepatitis C in Pregnancy

NCT03570112 | Completed FDA Drug

• 1 other identifier: 18-08
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis C; Pregnancy Complications; Vertical Disease Transmission

Outcome Measures

Primary Outcomes (1)

• Evaluate the rate of vertical transmission

  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.

  12 months of age

Secondary Outcomes (5)

• SVR12

  12 weeks post treatment

• Pre-Term Birth

  12 weeks post partum

• Cholestasis of pregnancy

  12 weeks post partum

• Low Birth Weight

  12 weeks of age

• Presence and severity of NAS/NOWS

  12 weeks of age

Study Arms (1)

Pregnant Women with Hep C

SOF/VEL Therapy-sofosbuvir 400mg, velpatasvir 100mg, once daily for 12 weeks at 24 weeks post partum

Drug: SOF/VEL- sofosbuvir 400mg and velpatasvir 100mg

Interventions

SOF/VEL- sofosbuvir 400mg and velpatasvir 100mg DRUG

sofosbuvir 400mg and velpatasvir 100mg once daily for 12 weeks

Also known as: Epclusa

Pregnant Women with Hep C

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with singleton pregnancy and chronic HCV infection

You may qualify if:

• Age 18 or older
• Chronic HCV infection, as defined by positive HCV antibody with confirmation of positive HCV RNA PCR at least 6 months apart, per 2017 AASLD/IDSA criteria. Infection with any genotype (including mixed genotypes) is permitted.
• If the diagnosis of chronic HCV is not established by two positive viral load (RNA PCR) tests 6 months apart, subjects may be enrolled and followed until the 6-month test is performed. If the follow-up viral load test is negative (i.e. the woman had acute infection that has cleared), the participant will be excluded from further study participation. All participants excluded for this reason will be replaced.
• Singleton pregnancy, up to and including 36 weeks' gestation, as documented by fetal ultrasound at any time during the pregnancy.
• Willing and able to understand and sign the informed consent form
• Willing and able to sign release of Information forms for their own medical and obstetric care and for their infant's neonatal and pediatric care for one year following delivery, or when the last study viral load test is performed, whichever comes later.

You may not qualify if:

• Co-infection with chronic hepatitis B.
• Active injection drug use, defined as the parenteral use of any substance for non-medicinal purposes in the previous 60 days. Potential subjects who have a history of active injection drug use will be referred to both syringe services programs to prevent the acquisition of HIV and HBV and to substance abuse treatment. Potential subjects who have injected within the last 60 days may be re-screened if they participate in a drug treatment program, subject to the discretion of the investigator.
• Decompensated cirrhosis, as determined by clinical history or examination

Sponsors & Collaborators

• The Christ Hospital: lead
• Gilead Sciences: collaborator

Study Sites (1)

Lindner Research Center at the Christ hospital

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Hepatitis C; Pregnancy Complications

Interventions

velpatasvir; sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• John Cafardi, MD

  The Christ Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. John Cafradi, MD, Infectious Disease Specialist

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: June 26, 2018
• Study Start: June 8, 2018
• Primary Completion: November 22, 2022
• Study Completion: February 27, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)