Hepatitis C Virus InfectionNCT04852614
Pharmacokinetics of Sofosbuvir/Daclatasvir in HCV-infected Lactating Women
An observational study of Hepatitis C Virus Infection, run by Ain Shams University at 1 site in Egypt.
Trial 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 breastfeeding to initiate HCV infection treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hepatitis C Virus Infection
- What is being tested?
- Pharmacokinetic test
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Lactating HCV infected female patients
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Cairo, Non-US, 11566
Fatma Soliman E Ebeid, 01095569596, dr.fatma_ebeid@yahoo.com
About this study
Official title: Pharmacokinetics of Sofosbuvir/Daclatasvir in HCV-infected Lactating Women: a Pilot Study
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 breastfeeding to initiate HCV infection treatment. Therefore, drug concentrations can be determined in maternal plasma and milk without risk to the children. HCV infected women at weaning after various durations of breastfeeding and HCV infected women who wish to initiate treatment immediately after delivery and forego breastfeeding will be recruited to start treatment under the guidance of their physician with SOF/DAC to determine M/P ratios of each of SOF, GS-331007 and DAC.
Read the 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 children and a warning will be given to abstain from any breast-feeding once treatment is started. This treatment is prescribed by the physician either the patients choose to participate in the study or not. In addition, effective contraceptive methods should be used. The treatment consists of SOF/DAC: 400 mg sofosbuvir and 60 mg daclatasvir administered with food for 12 weeks.
All recruited patients will be screened for the following data at baseline: Serum creatinine, bilirubin, albumin, AST, ALT, prothrombin time (PT), CBC, and viral load by PCR. The patient's general and demographic information (age, gender, height, and weight), comorbidities, and concurrent medications will be assessed and recorded in a specially designed patient data sheet.
The study will be conducted in the Faculty of Medicine Ain-Shams Research Institute Clinical Research Center (MASRI -CRC). After the first dose, women will be instructed to express their milk and discard it on the first two days and come to the research center on the third day for plasma and milk sampling. Patients will be instructed to take the dose on time especially the day before sampling. They will be asked to record the time of dose administration. They might be also followed up by telephone calls
- Conditions
- Hepatitis C Virus Infection
- Being tested
- Pharmacokinetic test
- Keywords
- Egypt, Sofosbuvir/daclatasvir, Pharmacokinetics, Lactating Women
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacokinetic testDiagnostic test
Blood samples will be collected 48 hours after the first dose on day 3 of the observed intake of the study medication at the following time points: t=0 (pre-dose), 1, 2, 3, 4, 8 and 12 hours post ingestion (7 samples) (3 mL each), Breast milk samples will be collected by emptying both breasts at 0, 2, 4, 8 and 12 hours (5 samples).
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma and milk concentrations of sofosbuvir
Determination of plasma and milk concentrations of sofosbuvir and its metabolite GS-331007 in plasma and milk of HCV infected lactating women.
Measured: Time prior to first dose till 24 hours post first dose of sofosbuvir
Plasma and milk concentrations of daclatasvir
Determination of plasma and milk concentrations of daclatasvir in plasma and milk of HCV infected lactating women
Measured: Time prior to first dose till 24 hours post first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start1 Dec 2020
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Virus InfectionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manal Hamdy El-Sayed, Ain Shams University
- Investigators
- Manal SE El-Sayed, M.D, Principal investigator, Ain Shams University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852614
- Sponsor's protocol ID
- CL 2489
- Status last verified
- Aug 2022
- First submitted
- 17 Apr 2021
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Sofosbuvir/Daclatasvir in HCV-infected Lactating Women: a Pilot Study
- ClinicalTrials.gov ID
- NCT04852614
- Acronym / sponsor ID
- CL 2489
- Conditions
- Hepatitis C Virus Infection
- Keywords
- Egypt, Sofosbuvir/daclatasvir, Pharmacokinetics, Lactating Women
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 breastfeeding to initiate HCV infection treatment. Therefore, drug concentrations can be determined in maternal plasma and milk without risk to the children. HCV infected women at weaning after various durations of breastfeeding and HCV infected women who wish to initiate treatment immediately after delivery and forego breastfeeding will be recruited to start treatment under the guidance of their physician with SOF/DAC to determine M/P ratios of each of SOF, GS-331007 and DAC.
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 children and a warning will be given to abstain from any breast-feeding once treatment is started. This treatment is prescribed by the physician either the patients choose to participate in the study or not. In addition, effective contraceptive methods should be used. The treatment consists of SOF/DAC: 400 mg sofosbuvir and 60 mg daclatasvir administered with food for 12 weeks.
All recruited patients will be screened for the following data at baseline: Serum creatinine, bilirubin, albumin, AST, ALT, prothrombin time (PT), CBC, and viral load by PCR. The patient's general and demographic information (age, gender, height, and weight), comorbidities, and concurrent medications will be assessed and recorded in a specially designed patient data sheet.
The study will be conducted in the Faculty of Medicine Ain-Shams Research Institute Clinical Research Center (MASRI -CRC). After the first dose, women will be instructed to express their milk and discard it on the first two days and come to the research center on the third day for plasma and milk sampling. Patients will be instructed to take the dose on time especially the day before sampling. They will be asked to record the time of dose administration. They might be also followed up by telephone calls
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lactating HCV infected female patients
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacokinetic testBlood samples will be collected 48 hours after the first dose on day 3 of the observed intake of the study medication at the following time points: t=0 (pre-dose), 1, 2, 3, 4, 8 and 12 hours post ingestion (7 samples) (3 mL each), Breast milk samples will be collected by emptying both breasts at 0, 2, 4, 8 and 12 hours (5 samples). | Diagnostic test | – |
Primary outcome
Plasma and milk concentrations of sofosbuvir
Time frame: Time prior to first dose till 24 hours post first dose of sofosbuvir
Determination of plasma and milk concentrations of sofosbuvir and its metabolite GS-331007 in plasma and milk of HCV infected lactating women.
Plasma and milk concentrations of daclatasvir
Time frame: Time prior to first dose till 24 hours post first dose
Determination of plasma and milk concentrations of daclatasvir in plasma and milk of HCV infected lactating women
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manal SE El-Sayed, M.D principal investigator
Ain Shams University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C Virus Infection, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manal H El-Sayed, MD (01227461120 ext. 002, manalhelsayed@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma and milk concentrations of sofosbuvir (time frame: Time prior to first dose till 24 hours post first dose of sofosbuvir). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.