Ursodeoxycholic Acid And Cholestasis Of Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-11-30

Brief Summary

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The study is a multicenter randomized double blind placebo controlled trial. The study will be conducted on pregnant women with a diagnosis of intrahepatic cholestasis of pregnancy (ICP) in third level hospitals (that are also Academic Hospitals).

Pregnant women at the time of ICP diagnosis will be randomized in two groups:

Group 1 - will receive placebo and obstetrical monitoring until delivery Group 2 - will receive UDCA at the dose of 20 mg/Kg/day and obstetrical monitoring until delivery.

The hypotheses are that UDCA treatment will be superior to placebo and effective in:

reducing the rate of prematurity; improving maternal biochemical parameters and symptoms.

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Detailed Description

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Conditions

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Intrahepatic Cholestasis of Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

obstetrical monitoring plus placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery

Ursodeoxycholic acid

obstetrical monitoring plus active drug

Group Type EXPERIMENTAL

Ursodeoxycholic Acid

Intervention Type DRUG

300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery

Interventions

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Ursodeoxycholic Acid

300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery

Intervention Type DRUG

Placebo

300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pregnant state (after week 20 of gestation)
* Total Serum BA elevation (\>10 micromol/l)
* Transaminases elevation (ALT\>40 UI/L and AST\>37 UI/L)
* Occurrence of pruritus
* Informed consent signed

Exclusion Criteria

* Infectious diseases (HBV, HDV, HCV related liver disease, EBV, CMV, HIV infection)
* Dermatologic diseases
* Metabolic diseases (including alcohol abuse)
* Other causes of cholestasis (i.e. PBC; PSC)
* 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
* Patients not able or not willing to follow the procedures of the protocol
* Patients not signing the informed consent
* Onset of ICP during of after the 36th week of pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No