PHASE III DOUBLE BLIND PLACEBO CONTROLLED RANDOMIZED STUDY ON THE EFFICACY OF URSODEOXYCHOLIC ACID FOR THE TREATMENT OF INTRAHEPATIC CHOLESTASIS OF PREGNANCY - CERTO_01 2008

Active, not recruiting

• Conditions: INTRAHEPATIC CHOLESTASIS OF PREGNANCY; MedDRA version: 9.1Level: LLTClassification code 10049055Term: Cholestasis of pregnancy

• Registration Number: EUCTR2008-001323-64-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-10
• Last Update Posted: 24 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary aim of the study is to evaluate the efficacy of UDCA treatment:<br>on delivery week (reducing the rate of prematurity)<br>Both spontaneous and therapeutic deliveries induced before week 37 will be considered preterm.;Secondary Objective: Secondary aims are:<br>to evaluate the efficacy of UDCA treatment on maternal biochemical parameters (transaminases and bile acids) and pruritus<br>to evaluate the efficacy of UDCA treatment on the incidence of fetal adverse events (fetal stress, stillbirths, green stained amniotic fluid).<br>to identify indicators of preterm delivery.;Primary end point(s): The primary efficacy variable is preterm delivery