Status:
UNKNOWN
Pharmacokinetics of Sofosbuvir/Daclatasvir in HCV-infected Lactating Women
Lead Sponsor:
Ain Shams University
Conditions:
Hepatitis C Virus Infection
Eligibility:
FEMALE
18+ years
Brief Summary
This is a prospective, observational, open-label, pharmacokinetic study will evaluate PK of SOF/DAC in lactating HCV-infected females at weaning or women who voluntarily decided to forego breastfeedin...
Detailed Description
Eligible women will be advised to arrange for initiation of treatment with their physician once they decide to stop breastfeeding. Treatment will be initiated once the women decide to wean their child...
Eligibility Criteria
Inclusion
- Patient is at least 18 years of age at the day of screening.
- Confirmed HCV infection by PCR and known genotype (GT) 1, 4, 5, or 6.
- Female lactating patient, who will wean their children on starting treatment and ensure not to breastfeed after start treatment.
- Patients with an indication for SOF/DAC treatment for the treatment of chronic HCV.
- Patient is able and willing to sign the Informed Consent Form.
- Patient is able and willing to follow protocol requirements.
Exclusion
- Need for co-treatment with ribavirin.
- HepBSAg positive test at screening.
- Treatment with rosuvastatin.
- Medicinal products that are potent P-glycoprotein (P-gp) and or CYP3A4 inducers in the intestine (rifampicin, rifabutin, St. John's wort \[Hypericum perforatum\], carbamazepine, phenobarbital and phenytoin).
- HIV co-infected patients using antiretroviral agents possibly interacting with SOF/DAC.
- Drugs associated with bradycardia including amiodarone.
- History of heart block.
- eGFR \< 30 ml/min/1.73 m2.
- Compensated cirrhosis, based on historical data, evidence of decompensated cirrhosis by ascites, encephalopathy, or variceal hemorrhage and/or abnormal ALT/AST/INR/thrombocytes indicating cirrhosis.
- Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion except for conditions related to HCV.
- Clinically relevant low hemoglobin concentration at screening.
- Pregnancy
- Refusal to use proper contraception during treatment
Key Trial Info
Start Date :
December 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04852614
Start Date
December 1 2020
End Date
December 1 2023
Last Update
August 23 2022
Active Locations (1)
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1
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Cairo, Non-US, Egypt, 11566