A study of therapy for hepatitis C in pregnancy

Phase 4

Recruiting

• Conditions: Pregnancy; Infection - Other infectious diseases; Reproductive Health and Childbirth - Normal pregnancy; Hepatitis C

• Registration Number: ACTRN12619000054112
• Lead Sponsor: Monash Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-15
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

Pregnant women mono-infected with hepatitis C, able to provide written, informed consent, will need to be able to provide contact details, have any HCV genotype with a detectable HCV RNA viral load at screening >1000 IU/ml, a gestational age of 22 weeks at enrollment and a singleton pregnancy with no known fetal anomalies (as confirmed on routine 18-22 week ultrasound).

Exclusion Criteria

Women will be excluded from the study if they have previously had treatment for HCV with a NS5A inhibitor, use of any medications contraindicated with SOF/VEL, have a history of cirrhosis, have any significant uncontrolled active or chronic cardiovascular, renal, or liver disease, haematological, neurological, immunological or infectious disease (other than HCV), have a high risk of preterm birth (defined as a history of preterm birth at less than 34 weeks or a shortened cervical length of less than 20 millimeters).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The inactive Sofosbuvir metabolite GS-331007 will be measured pre and post dose to determine pharmacokinetics (Tmax, AUC, T1/2 and Cmin) by serum assay. [Systemic exposure to sofosbuvir will be assessed at three gestational time points (between 25+0 weeks gestation and 26+5 weeks gestation; between 29+0 and 30+6 weeks gestation; and between 33+0 and 34+6 weeks gestation). ];Velpatasvir will be measured pre and post dose to determine pharmacokinetics (Tmax, AUC, T1/2 and Cmin) by serum assay. [Systemic exposure to velpatasvir will be assessed at three gestational time points (between 25+0 weeks gestation and 26+5 weeks gestation; between 29+0 and 30+6 weeks gestation; and between 33+0 and 34+6 weeks gestation). ]

Secondary Outcome Measures

Name	Time	Method
A sustained virological response (SVR) as assessed by a HCV RT-PCR of maternal serum.[12 weeks post end of treatment];Perinatal HCV transmission as assessed by a HCV RT-PCR of neonatal serum.[6 months of age of the child]