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Ursodeoxycholic Acid And Cholestasis Of Pregnancy (CERTO)

Primary Purpose

Intrahepatic Cholestasis of Pregnancy

Status
Withdrawn
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Ursodeoxycholic Acid
Placebo
Sponsored by
University of Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intrahepatic Cholestasis of Pregnancy focused on measuring cholestasis, pregnancy, ursodeoxycholic acid, ICP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Divisione di Gastroenterologia, IRCCS Casa Sollievo della Sofferenza
  • UOC Ostetricia e Ginecologia, Ospedale Maggiore
  • S.Orsola-Malpighi Hospital
  • Gastroenterology and Liver Clinic, Azienda Ospedaliero-Universitaria, University of Modena and Reggio Emilia
  • Dept. of Surgical and Gastroenterological Sciences, University of Padova
  • Gastroenterology Unit, Policlinic of Palermo
  • Internal Medicine Department, Gemelli Hospital, Catholic University of Sacred Heart

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Ursodeoxycholic acid

Arm Description

obstetrical monitoring plus placebo

obstetrical monitoring plus active drug

Outcomes

Primary Outcome Measures

Number of participants with preterm delivery (before week 37)

Secondary Outcome Measures

Pruritus on the Visual Analogue Scale
Transaminases
Bile Acids
Fetal movement count
mother evaluation
Number of pregnancies with cardiotocography suggestive of fetal stress
APGAR index
Number of pregnancies with Green stained amniotic fluid
obstetrician evaluation

Full Information

First Posted
October 19, 2010
Last Updated
May 10, 2016
Sponsor
University of Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT01226823
Brief Title
Ursodeoxycholic Acid And Cholestasis Of Pregnancy
Acronym
CERTO
Official Title
Intrahepatic Cholestasis Of Pregnancy: Clinical Impact Of Ursodeoxycholic Acid Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Modified insurance requests by a new law released after its approval.
Study Start Date
November 2010 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
November 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bologna

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrahepatic Cholestasis of Pregnancy
Keywords
cholestasis, pregnancy, ursodeoxycholic acid, ICP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
obstetrical monitoring plus placebo
Arm Title
Ursodeoxycholic acid
Arm Type
Experimental
Arm Description
obstetrical monitoring plus active drug
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic Acid
Intervention Description
300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery
Primary Outcome Measure Information:
Title
Number of participants with preterm delivery (before week 37)
Time Frame
at the time of delivery
Secondary Outcome Measure Information:
Title
Pruritus on the Visual Analogue Scale
Time Frame
from enrollment until delivery
Title
Transaminases
Time Frame
from enrolment until delivery
Title
Bile Acids
Time Frame
from enrolment until delivery
Title
Fetal movement count
Description
mother evaluation
Time Frame
from enrolment until delivery
Title
Number of pregnancies with cardiotocography suggestive of fetal stress
Time Frame
from enrolment until delivery
Title
APGAR index
Time Frame
1 and 5 minutes after birth
Title
Number of pregnancies with Green stained amniotic fluid
Description
obstetrician evaluation
Time Frame
at delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Mazzella, Professor
Organizational Affiliation
University of Bologna
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Francesco Azzaroli, Professor
Organizational Affiliation
University of Bologna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Divisione di Gastroenterologia, IRCCS Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
State/Province
Foggia
ZIP/Postal Code
71013
Country
Italy
Facility Name
UOC Ostetricia e Ginecologia, Ospedale Maggiore
City
Bologna
ZIP/Postal Code
40100
Country
Italy
Facility Name
S.Orsola-Malpighi Hospital
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Gastroenterology and Liver Clinic, Azienda Ospedaliero-Universitaria, University of Modena and Reggio Emilia
City
Modena
Country
Italy
Facility Name
Dept. of Surgical and Gastroenterological Sciences, University of Padova
City
Padua
ZIP/Postal Code
34100
Country
Italy
Facility Name
Gastroenterology Unit, Policlinic of Palermo
City
Palermo
Country
Italy
Facility Name
Internal Medicine Department, Gemelli Hospital, Catholic University of Sacred Heart
City
Rome
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
32716060
Citation
Walker KF, Chappell LC, Hague WM, Middleton P, Thornton JG. Pharmacological interventions for treating intrahepatic cholestasis of pregnancy. Cochrane Database Syst Rev. 2020 Jul 27;7(7):CD000493. doi: 10.1002/14651858.CD000493.pub3.
Results Reference
derived

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Ursodeoxycholic Acid And Cholestasis Of Pregnancy

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