Ursodeoxycholic Acid And Cholestasis Of Pregnancy (CERTO)

University of Bologna

Status and phase: Withdrawn; Phase 3

Conditions: Intrahepatic Cholestasis of Pregnancy

Treatments: Drug: Ursodeoxycholic Acid; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01226823

CERTO

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

obstetrical monitoring plus placebo

Treatment:

Drug: Placebo

Ursodeoxycholic acid

Experimental group

Description:

obstetrical monitoring plus active drug

Treatment:

Drug: Ursodeoxycholic Acid