Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy (NCT05140941) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
United States100 participantsStarted 2022-04-04
Plain-language summary
This is a multicenter, single arm study of Sofosbuvir/Velpatasvir (SOF/VEL) for treatment of chronic hepatitis C infection during pregnancy. Treatment will be initiated during the second or third trimester in approximately 100 pregnant people. Maternal participants will take one SOF/VEL tablet once daily for 12 weeks (84 days) and followed until 12 weeks after treatment completion (postpartum). Infants will be followed from birth until one year of age. The primary objectives are to evaluate the sustained virologic response 12 weeks after completion of SOF/VEL treatment (SVR12) in participants treated during pregnancy and to evaluate impact of antenatal treatment with SOF/VEL on the gestational age at delivery.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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Inclusion criteria
✓. Age 18 through 45 years (inclusive) at screening
✓. Able and willing to provide written informed consent and take part in the study procedures
✓. Able and willing to provide adequate locator information, defined as at least two other alternate contacts
✓. HCV antibody seropositivity with detectable HCV RNA viral load at screening
✓. Chronic HCV infection of at least 6 months by laboratory report or participant reported medical history as determined by the site PI, or if duration of HCV cannot be determined then the participant can be enrolled if there is no clinical evidence of acute hepatitis C infection (defined by CDC as presence of jaundice or total bilirubin \>/= 3.0 mg/dL or ALT \>200IU/L)
✓. Singleton pregnancy at 20 + 0 to 30 + 0 weeks' gestation at enrollment with gestational dating confirmed by ultrasound
✓. Having a comprehensive anatomy scan with no evidence of major structural abnormalities as defined by the CDC birth surveillance toolkit (https://www.cdc.gov/ncbddd/birthdefects/surveillancemanual/chapters/chapter-4/chapter4-1.html) or an anomaly that would significantly impact delivery timing or neonatal outcomes as determined by the Protocol Safety Review Team (PSRT) prior to enrollment
✓
What they're measuring
1
Number of maternal participants with sustained virologic response after completion of SOF/VEL treatment (SVR12)
Timeframe: Approximately 12 weeks
2
Number of maternal participants that deliver prior to 37 weeks' gestation
. Documented negative Hepatitis B testing for current infection (negative HBsAg test) prior to enrollment
Exclusion criteria
✕. Participant report of any of the following at screening or enrollment:
✕. Previous DAA treatment for HCV (prior interferon-based treatment is acceptable) without documentation of SVR12 (HCV RNA below the lower limit of quantification at least 24 weeks after DAA initiation)
✕. Use of any medications contraindicated with concurrent use of velpatasvir or sofosbuvir according to the most current EPCLUSA® package insert30
✕. Plans to relocate away from the study site area in the next 16 months and unable/unwilling to return for study visits
✕. History of cirrhosis documented or reported by previous liver biopsy, imaging tests or on at least 2 noninvasive laboratory tests of fibrosis, including compensated cirrhosis
✕. Reports participating in any other research study involving investigational medications or investigational medical devices within 60 days or less prior to enrollment (does not include research studies involving standard of care medications)
✕. Known fetal chromosomal abnormality prior to enrollment (confirmed by chorionic villus sampling or amniocentesis)
✕. Clinically significant and habitual non-therapeutic drug use, not including marijuana, as determined by site PI at screening and enrollment