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The study will include participants who were exposed to at least one dose of elafibranor either within the three weeks before conception or at any time during pregnancy (based on estimated last menstrual period [LMP]).
Information will be collected from participants, their healthcare providers, published studies, and safety databases. Reports of pregnancy linked to elafibranor from clinical trials, spontaneous reports, or literature will also be included, with steps taken to avoid duplicates.
The study begins once the first participant is enrolled and ends after the last mother and child data are collected. It is planned to run for about 10 years, with infant follow-up lasting up to 2 years, for a maximum total duration of 12 years and 9 months.
The program is strictly observational. All medical care, visit schedules, and treatment decisions remain with healthcare providers. Only routine medical record data will be collected, and no extra tests or procedures are required.
Participation is voluntary, and written informed consent will be obtained before enrollment.
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of congenital malformations at birth | At birth |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of major congenital malformations at birth | An abnormality of body structure or function that is present at birth; is of prenatal origin (i.e. birth defect); has significant medical, social, or cosmetic consequences for the affected individual; and typically requires medical intervention | At birth |
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Inclusion Criteria:
Exclusion Criteria:
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Child-bearing potential women: individuals of any age who are exposed to at least 1 dose of elafibranor at any time during pregnancy and/or lactation.
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The participants of this study will be of any age who are exposed to at least one dose of elafibranor at any time during pregnancy, or since 3 weeks prior to the conception (based on estimated last menstrual period [LMP])
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ipsen Clinical Study Enquiries | Contact | See e-mail | clinical.trials@ipsen.com |
| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
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Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).
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| ID | Term |
|---|---|
| D035583 | Rare Diseases |
| D008105 | Liver Cirrhosis, Biliary |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002780 | Cholestasis, Intrahepatic |
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| Prevalence of minor congenital malformations at birth |
An anomaly or abnormality of body structure that is present at birth, is of prenatal origin (i.e. birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected individual |
| At birth |
| Prevalence of molar/ectopic pregnancy | Molar pregnancy is defined as an abnormal pregnancy that happens when a sperm fertilizes an egg that does not contain any genetic material. Ectopic pregnancy is defined as a pregnancy that occurs outside of the uterine cavity, usually in one of the fallopian tubes. | Throughout pregnancy, an average of 9 months |
| Prevalence of fetal loss | A fetal loss that occurs for any reason at any time during pregnancy. This includes spontaneous abortion (SAB), stillbirth, elective or therapeutic abortion, fetal loss (type not specified). | Throughout pregnancy, an average of 9 months |
| Prevalence of live birth | The birth of a living fetus at ≥ 20 gestational weeks or, if gestational age is unknown, weighing ≥ 350g. | At birth |
| Prevalence rate of premature delivery | A live birth occurring at <37 gestational weeks. | At birth |
| Prevalence of infants born small for gestational age (SGA) at birth | Birth weight <10th percentile for sex and gestational age using standard growth charts for full and preterm live-born infants. | At birth |
| Prevalence of neonatal death | Within the first 28 days of life |
| Prevalence infant death | Throughout the first year of life |
| Prevalence of postnatal growth deficiency | Weight, length, or head circumference in <10th percentile for sex and age using standard growth charts | Throughout the two years of life |
| Prevalence of infant developmental delay | Failure to achieve the developmental milestones for chronological age, as defined by the Centers for Disease Control and Prevention (CDC) | Throughout the two years of life |
| Prevalence of infant healthcare requirements and interventions not considered standard | including but not limited to:
| Throughout the two years of life |
| Incidence and nature of all adverse events in pregnant participants | Throughout pregnancy, an average of 9 months |
| Changes from baseline in Alkaline phosphatase (ALP) | From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months |
| Changes from baseline in Bilirubin | From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months |
| Changes from baseline in Alanine aminotransferase (ALT) | From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months |
| Changes from baseline in Aspartate aminotransferase (AST) | From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months |
| Changes from baseline in Gamma-glutamyl transferase (GGT) | From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months |
| Changes from baseline in Albumin | From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months |
| Changes from baselinein Bile Acids | From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months |
| Changes from baseline in Creatine phosphokinase (CPK) | From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months |
| Changes from baseline in Lipid Profile | Lipid profile includes total cholesterol, low density lipoproteins (LDL-C), high density lipoprotein (HDL-C), very low density lipoprotein and triglycerides | From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months |
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |