E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
INTRAHEPATIC CHOLESTASIS OF PREGNANCY |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049055 |
E.1.2 | Term | Cholestasis of pregnancy |
|
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 aim of the study is to evaluate the efficacy of UDCA treatment: on delivery week (reducing the rate of prematurity) Both spontaneous and therapeutic deliveries induced before week 37 will be considered preterm. |
|
E.2.2 | Secondary objectives of the trial |
Secondary aims are: to evaluate the efficacy of UDCA treatment on maternal biochemical parameters (transaminases and bile acids) and pruritus to evaluate the efficacy of UDCA treatment on the incidence of fetal adverse events (fetal stress, stillbirths, green stained amniotic fluid). to identify indicators of preterm delivery. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria will be the following: Pregnant state (after week 20 of gestation) Age ≥18 years Informed consent signed Total Serum BA elevations (>10 micromol/l) Transaminases elevations (ALT>19 UI/L and AST>37 UI/L) Occurrence of pruritus |
|
E.4 | Principal exclusion criteria |
The exclusion criteria will be: infectious diseases (HBV, HDV, HCV related liver disease, EBV, CMV, HV infection) dermatologic diseases Patients not able or not willing to follow the procedures of the protocol Patients not signing the informed consent Age<18 years Onset of ICP during of after the 36th week of pregnancy
metabolic diseases (including alcohol abuse) Primary biliary cirrhosis Sclerosing Cholangitis Autoimmune liver disease Obstructive biliary diseases Drug related pathologies Known or suspected hyper-sensibility to the drug or the pharmacological class under study Serious clinical conditions that, according to the judgment of the investigator, contraindicate the participation to the study (heart, kidney and liver disease) Use of cholestyramine |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is preterm delivery |
|
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 | Yes |
E.6.6 | Pharmacokinetic | No |
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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
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 | Information not present in EudraCT |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |