Ursodeoxycholic Acid And Cholestasis Of Pregnancy - Full Text View

Purpose

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.

Condition	Intervention	Phase
Intrahepatic Cholestasis of Pregnancy	Drug: Ursodeoxycholic Acid Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Intrahepatic Cholestasis Of Pregnancy: Clinical Impact Of Ursodeoxycholic Acid Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: intrahepatic cholestasis of pregnancy progressive familial intrahepatic cholestasis

Drug Information available for: Ursodiol

U.S. FDA Resources

Further study details as provided by University of Bologna:

Primary Outcome Measures:

Number of participants with preterm delivery (before week 37) [ Time Frame: at the time of delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pruritus on the Visual Analogue Scale [ Time Frame: from enrollment until delivery ] [ Designated as safety issue: No ]
Transaminases [ Time Frame: from enrolment until delivery ] [ Designated as safety issue: No ]
Bile Acids [ Time Frame: from enrolment until delivery ] [ Designated as safety issue: No ]
Fetal movement count [ Time Frame: from enrolment until delivery ] [ Designated as safety issue: No ]
mother evaluation
Number of pregnancies with cardiotocography suggestive of fetal stress [ Time Frame: from enrolment until delivery ] [ Designated as safety issue: No ]
APGAR index [ Time Frame: 1 and 5 minutes after birth ] [ Designated as safety issue: No ]
Number of pregnancies with Green stained amniotic fluid [ Time Frame: at delivery ] [ Designated as safety issue: No ]
obstetrician evaluation

Estimated Enrollment:	118
Study Start Date:	November 2010
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo obstetrical monitoring plus placebo	Drug: Placebo 300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery
Experimental: Ursodeoxycholic acid obstetrical monitoring plus active drug	Drug: Ursodeoxycholic Acid 300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01226823

Contacts

Contact: Giuseppe Mazzella, Professor

+390516364120

giuseppe.mazzella@unibo.it

Locations

Italy
Divisione di Gastroenterologia, IRCCS Casa Sollievo della Sofferenza	Not yet recruiting
San Giovanni Rotondo, Foggia, Italy, 71013
Contact: Alessandra Mangia, MD
Principal Investigator: Alessandra Mangia, MD
S.Orsola-Malpighi Hospital	Not yet recruiting
Bologna, Italy, 40138
Contact giuseppe.mazzella@unibo.it
Contact francesco.azzaroli@unibo.it
Principal Investigator: Francesco Azzaroli, Professor
Sub-Investigator: Andrea Lisotti, MD
UOC Ostetricia e Ginecologia, Ospedale Maggiore	Not yet recruiting
Bologna, Italy, 40100
Contact: Scagliarini Giorgio, Dr. giorgio.scagliarini@ausl.bo.it
Principal Investigator: Giorgio Scagliarini, Dr.
Gastroenterology and Liver Clinic, Azienda Ospedaliero-Universitaria, University of Modena and Reggio Emilia	Not yet recruiting
Modena, Italy
Contact: Erica Villa, Professor +390594222111
Principal Investigator: Erica Villa, Professor
Dept. of Surgical and Gastroenterological Sciences, University of Padova	Not yet recruiting
Padua, Italy, 34100
Contact: Annarosa Floreani, Professor +390498212894 annarosa.floreani@unipd.it
Principal Investigator: Annarosa Floreani, Professor
Gastroenterology Unit, Policlinic of Palermo	Not yet recruiting
Palermo, Italy
Contact: Carlo Cammà, Professor carlo.cammà@unipa.it
Principal Investigator: Carlo Cammà, Professor
Internal Medicine Department, Gemelli Hospital, Catholic University of Sacred Heart	Not yet recruiting
Rome, Italy, 00168
Contact: Antonio Gasbarrini, Professor agasbarrini@rm.unicatt.it
Principal Investigator: Antonio Gasbarrini, Professor

Sponsors and Collaborators

University of Bologna

Investigators

Study Director:	Giuseppe Mazzella, Professor	University of Bologna
Principal Investigator:	Francesco Azzaroli, Professor	University of Bologna

More Information

No publications provided

Responsible Party:	Prof. Giuseppe Mazzella, S.Orsola-Malpighi Hospital/University of Bologna
ClinicalTrials.gov Identifier:	NCT01226823 History of Changes
Other Study ID Numbers:	CERTO
Study First Received:	October 19, 2010
Last Updated:	October 21, 2010
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by University of Bologna:

cholestasis
pregnancy
ursodeoxycholic acid
ICP

Additional relevant MeSH terms:

Pregnancy Complications
Cholestasis
Cholestasis, Intrahepatic
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

Liver Diseases
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013

Ursodeoxycholic Acid And Cholestasis Of Pregnancy (CERTO)