Phase 1 Pharmacokinetic Trial of Sofosbuvir/Velpatasvir in Pregnant Women With Chronic Hepatitis C Virus Infection

STUDY19100377

A single-arm, single-center, open label Phase 1 study of a 12-week course of Sofosbuvir (SOF)/Velpatasvir (VEL) in 10 HCV-infected pregnant women 1 that will evaluate the plasma pharmacokinetic parameters of SOF/VEL administered during pregnancy and compare them to those of a historical cohort of nonpregnant women.

2020-10-22

2023-10-16

2023-10-16

Completed

Early phase I

11

Inclusion Criteria: * Able and willing to provide written informed consent and take part in the study -procedures * Able and willing to provide adequate locator information * Chronic hepatitis C viral (HCV) infection, defined as a positive HCV test at least 6 months prior to screening * Detectable HCV RNA viral load at Screening * Desired pregnancy at 23 + 0 to 25 + 6 weeks' gestation at enrollment with gestational dating confirmed by ultrasound * Singleton gestation with no known fetal abnormalities * Documented negative Hepatitis B (HB) testing for current infection (negative HB serum antigen test) or previous infection (negative anti-HB Core) performed at the screening visit * Negative HIV testing at the screening visit * Per participant report at screening and enrollment, agrees not to participate in other research studies involving drugs or medical devices for the duration of study participation Exclusion Criteria: * Participant report of any of the following at screening or enrollment: 1. Previous treatment for Hepatitis C virus with sofosbuvir or a non-structural protein 5A inhibitor 2. Use of any medications contraindicated with concurrent use of velpatasvir or sofosbuvir according to the most current Epclusa package insert 3. Plans to relocate away from the study site area in the next 1 year and 4 months and unable/unwilling to return for study visits 4. Current sexual partner is known to be infected with HIV or Hepatitis B virus 5. History of cirrhosis documented or reported by previous liver biopsy or liver imaging tests * Reports participating in any other research study involving drugs or medical devices within 60 days or less prior to enrollment * Clinically significant and habitual non-therapeutic drug abuse, not including marijuana, as determined by Protocol Chair * At Screening or Enrollment, as determined by the Protocol Chair, any significant uncontrolled active or chronic cardiovascular, renal, liver (such as evidence of decompensated cirrhosis by ascites, encephalopathy, or variceal hemorrhage), hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease (other than Hepatitis C) * Has a high risk of preterm birth defined as a history of spontaneous preterm birth at less than 34 weeks of gestation or a shortened cervical length of less than 20 millimeters * Has any of the following laboratory abnormalities at screening: 1. Aspartate aminotransferase or alanine transaminase greater than 10 times the upper limited of normal 2. Hemoglobin less than 9g/dL 3. Platelet count less than 90,000 per mm3 4. International normalized ratio \> 1.5 5. Creatinine greater than 1.4 * Has any other condition that, in the opinion of the investigator or designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open-label, single arm', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 11, 'type': 'ACTUAL'}}

2023-12-26