E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Future use for VTE prophylaxis. |
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E.1.1.1 | Medical condition in easily understood language |
First steps to see if Dabigatran could be used in the future for women who have had a Caesarean section in order to reduce the risk of blood clots. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the study is to determine if dabigatran and its metabolites are detectable in breast milk following oral administration to non-breast feeding mothers.
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to determine dabigatran pharmacokinetics (Tmax, Cmax, t1/2, AUC) in maternal plasma and breast milk (if dabigatran is detectable in breast milk).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Women aged ≥18 years • Woman has had a vaginal birth (spontaneous or instrumental) • Minimum of 48 hours has passed after delivery of the baby/ removal of epidural catheter or spinal anaesthesia • Minimum of 24 hours has passed after the decision has been made and documented in the notes to stop breast feeding the baby after starting/trying to start. • Hospital inpatient • Woman has been offered the opportunity to have a discussion at delivery and in the immediate postnatal period in relation to their feeding choices using the Feeding Your Baby booklet. • Decision has been confirmed by the woman to exclusively formula-feed her baby (including women who have since decided to stop breast-feeding their baby) • Midwife has confirmed the decision with the woman and has documented this in the Feeding Your Baby Booklet held in the medical notes. • Normal renal function test – results of the serum creatinine <90 micro mol/L. • Normal liver function tests – results of the serum ALT </= 40 IU/L. • Not taking any medication except paracetamol and / or dihydrocodeine. Women who have been given ibuprofen for pain relief after delivery can be included at least 24 hours after the last dose. Women will be advised not to take non-steroidal anti-inflammatory drugs (aspirin, ibuprofen, diclofenac, naproxen, indometnacin) for at least 3 days after taking the study treatment) • Participant has provided written informed consent for participation in the study before any study specific procedures take place.
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E.4 | Principal exclusion criteria |
• Women who are planning to/are breastfeeding • Women who are planning to/giving their baby expressed breast milk • Women who are unsure of their decision to breast feed or formula feed • Women who are unable to provide written informed consent • LMWH thromboprophylaxis is indicated • Increased risk of bleeding for any reason • An increased tendency to bleed (inborn, of unknown cause or due to other medications) • Known contra-indications to dabigatran • On-going treatment with aspirin, NSAIDs or other drugs that affect haemostasis • Treatment with oral ketoconazole or itraconazole, medicines to treat fungal infections • Patients who have received an artificial heart valve, have had a heart attack or suffer an irregular heartbeat (including taking dronedarone) • Known impaired renal function (serum creatinine > 90 micro mol/L) • Known abnormal liver function tests (ALT > 40 IU/L) • Known hypersensitivity or allergy to dabigatran • Use of other investigational study drugs within 30 days prior to study entry
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E.5 End points |
E.5.1 | Primary end point(s) |
To determine if Dabigatran is detectable in plasma and breast milk after it has been ingested by the mother. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
This will be measured at 0,1,2,5,7,10 hours after swallowing two 110mg capsules of dabigatran. |
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E.5.2 | Secondary end point(s) |
If Dabigatran is detected:
Time course of dabigatran concentration in breast milk.
Time course of dabigatran concentration in maternal plasma.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
This will be measured across the 0,1,2,5,7,10 hours after swallowing two 110mg capsules of dabigatran. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Database lock (all queries raised and resolved) and no further follow up data can be entered. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | 29 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 30 |