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Transmission of Chronic Hepatitis C in Pregnancy

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ClinicalTrials.gov Identifier: NCT03570112
Recruitment Status : Unknown
Verified July 2019 by John Cafardi, The Christ Hospital.
Recruitment status was:  Recruiting
First Posted : June 26, 2018
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
John Cafardi, The Christ Hospital

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.

Condition or disease Intervention/treatment
Hepatitis C Pregnancy Complications Vertical Disease Transmission Drug: SOF/VEL- sofosbuvir 400mg and velpatasvir 100mg

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of the Natural History and Vertical Transmission of Chronic Hepatitis C Virus Infection in Pregnancy With Targeted Elimination by Postpartum Treatment
Actual Study Start Date : June 8, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Group/Cohort Intervention/treatment
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
sofosbuvir 400mg and velpatasvir 100mg once daily for 12 weeks
Other Name: Epclusa




Primary Outcome Measures :
  1. Evaluate the rate of vertical transmission [ Time Frame: 12 months of age ]
    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.


Secondary Outcome Measures :
  1. SVR12 [ Time Frame: 12 weeks post treatment ]
    Evaluate SVR12 - Hepatitis C undetectable

  2. Pre-Term Birth [ Time Frame: 12 weeks post partum ]
    Defined as delivery between 20 and 37 weeks

  3. Cholestasis of pregnancy [ Time Frame: 12 weeks post partum ]
    Defined by the Society for Maternal Fetal Medicine, consisting of pruritis, absence of rash, serum bile acids > 10umol/liter with resolution following delivery

  4. Low Birth Weight [ Time Frame: 12 weeks of age ]
    Defined by the World Health Organization, infant weighing 2,499 grams or less at birth regardless of gestational age

  5. Presence and severity of NAS/NOWS [ Time Frame: 12 weeks of age ]
    Neonatal abstinence syndrome(NAS)/ neonatal opioid withdrawal syndrome(NOWS) by modified Finnegan Neonatal Abstinence Scoring System



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with singleton pregnancy and chronic HCV infection
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Any major medical comorbidity that may confound assessment, such as cardiomyopathy, pulmonary hypertension, type 1 diabetes mellitus or similar serious medical conditions at the discretion of the investigator. Gestational diabetes mellitus or co-infection with HIV are not criteria for exclusion.

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): NCT03570112


Contacts
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Contact: John Cafardi, MD 513-585-1777 john.carfardi@thechristhospital.com
Contact: Roxanne Robertson, RN 513-585-1777 roxanne.robertson@thechristhospital.com

Locations
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United States, Ohio
Lindner Research Center at the Christ hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: John Cafardi, MD    513-585-1777    john.cafardi@thechristhospital.com   
Contact: Roxanne Robertson, RN    513-585-1777    roxanne.robertson@thechristhospital.com   
Sponsors and Collaborators
The Christ Hospital
Gilead Sciences
Investigators
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Principal Investigator: John Cafardi, MD The Christ Hospital
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Responsible Party: John Cafardi, Dr. John Cafradi, MD, Infectious Disease Specialist, The Christ Hospital
ClinicalTrials.gov Identifier: NCT03570112    
Other Study ID Numbers: 18-08
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Pregnancy Complications
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Hepatitis, Chronic
Sofosbuvir
Velpatasvir
Antiviral Agents
Anti-Infective Agents