Ursodeoxycholic Acid And Cholestasis Of Pregnancy

Intrahepatic Cholestasis of Pregnancy Clinical Trial

— CERTO  

Official title:

Intrahepatic Cholestasis Of Pregnancy: Clinical Impact Of Ursodeoxycholic Acid Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01226823
• Other study ID #: CERTO
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 19, 2010
• Last updated: October 21, 2010
• Start date: November 2010

Study information

• Verified date: May 2010
• Source: University of Bologna
• Contact: Giuseppe Mazzella, Professor
• Phone: +390516364120
• Email: giuseppe.mazzella[@]unibo.it
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 118
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholestasis
• Cholestasis, Intrahepatic
• Intrahepatic Cholestasis of Pregnancy
• Pregnancy Complications

Intervention

Drug:
• Ursodeoxycholic Acid
300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery
• Placebo
300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery

Locations

Country	Name	City	State
Italy	S.Orsola-Malpighi Hospital	Bologna
Italy	UOC Ostetricia e Ginecologia, Ospedale Maggiore	Bologna
Italy	Gastroenterology and Liver Clinic, Azienda Ospedaliero-Universitaria, University of Modena and Reggio Emilia	Modena
Italy	Dept. of Surgical and Gastroenterological Sciences, University of Padova	Padua
Italy	Gastroenterology Unit, Policlinic of Palermo	Palermo
Italy	Internal Medicine Department, Gemelli Hospital, Catholic University of Sacred Heart	Rome
Italy	Divisione di Gastroenterologia, IRCCS Casa Sollievo della Sofferenza	San Giovanni Rotondo	Foggia

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with preterm delivery (before week 37)		at the time of delivery	No
Secondary	Pruritus on the Visual Analogue Scale		from enrollment until delivery	No
Secondary	Transaminases		from enrolment until delivery	No
Secondary	Bile Acids		from enrolment until delivery	No
Secondary	Fetal movement count	mother evaluation	from enrolment until delivery	No
Secondary	Number of pregnancies with cardiotocography suggestive of fetal stress		from enrolment until delivery	No
Secondary	APGAR index		1 and 5 minutes after birth	No
Secondary	Number of pregnancies with Green stained amniotic fluid	obstetrician evaluation	at delivery	No