EUCTR2018-003852-19-GBActive, not recruitingPhase 1
An Open Label, Non-Randomised, Phase IV Clinical Trial to Determine the Transfer of Apixaban and Rivaroxaban in Breast Milk Following Oral Administration - Apixaban and rivaroxaban in breast milk
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- King's College London
- Enrollment
- 4
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •1. Subject is informed and given ample time and opportunity to think about his/her participation and has provided written informed consent for participation in the study before any study specific procedures take place.
- •2. Subject is considered reliable and capable of adhering to applicable protocol requirements, including the study drug being administered orally and visit schedule according to the judgement of the Investigator.
- •3. Women are aged =18 years.
- •4. At least 6 weeks postpartum when enter the study.
- •5. Decision has been confirmed by the woman to stop breastfeeding their baby soon.
- •6. Negative pregnancy test.
- •7. Good physical and mental health, in the opinion of the Investigator, determined on the basis of medical history and general clinical examination at Screening.
- •8. Women have clinical laboratory test results within the reference ranges of the testing laboratory: normal renal function test – results of the serum creatinine <90 micro mol/L. Normal liver function tests – results of the serum ALT 9. Women are not taking any medication interacting with apixaban or rivaroxaban, as listed in table 6.4 and 6.5.
- •10. Women are available to attend scheduled visits at clinical unit and permit the clinic staffs visit home to collect blood and milk samples.
- •11. Women agree to the study restrictions
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 4
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. Women who are unable to provide written informed consent.
- •2. LMWH thromboprophylaxis is indicated.
- •3. Increased risk of bleeding for any reason.
- •4. Known contra-indications to apixaban or rivaroxaban.
- •5. On-going treatment with aspirin, NSAIDs or other drugs that affect haemostasis.
- •6. Treatment with oral ketoconazole or itraconazole, medicines to treat fungal infections.
- •7. Patients who have received an artificial heart valve, have had a heart attack or suffer an irregular heartbeat (including taking dronedarone).
- •8. Known impaired renal function (serum creatinine > 90 micro mol/L).
- •9. Known abnormal liver function tests (ALT > 40 IU/L).
- •10. Known hypersensitivity or allergy to apixaban or rivaroxaban.
- •11. Use of other investigational study drugs within 30 days prior to study entry.
- •12. Women who are pregnant or of childbearing potential who refuse to use an acceptable effective form of contraception throughout the study.
- •13. Women who will not participate in study visits within a suitable distance from King’s College Hospital NHS Foundation Trust, as judged by the investigator.
Investigators
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