Ursodeoxycholic Acid And Cholestasis Of Pregnancy

NCT01226823 | Withdrawn Phase 3

• 1 other identifier: CERTO
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 7

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.

Conditions

Intrahepatic Cholestasis of Pregnancy

Keywords

cholestasis; pregnancy; ursodeoxycholic acid; ICP

Outcome Measures

Primary Outcomes (1)

• Number of participants with preterm delivery (before week 37)

  at the time of delivery

Secondary Outcomes (7)

• Pruritus on the Visual Analogue Scale

  from enrollment until delivery

• Transaminases

  from enrolment until delivery

• Bile Acids

  from enrolment until delivery

• Fetal movement count

  from enrolment until delivery

• Number of pregnancies with cardiotocography suggestive of fetal stress

  from enrolment until delivery

Study Arms (2)

Placebo

PLACEBO COMPARATOR

obstetrical monitoring plus placebo

Drug: Placebo

Ursodeoxycholic acid

EXPERIMENTAL

obstetrical monitoring plus active drug

Drug: Ursodeoxycholic Acid

Interventions

Ursodeoxycholic Acid DRUG

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

Ursodeoxycholic acid

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (7)

Divisione di Gastroenterologia, IRCCS Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, 71013, Italy

Location

Dept. of Surgical and Gastroenterological Sciences, University of Padova

Padua, Italy, 34100, Italy

Location

UOC Ostetricia e Ginecologia, Ospedale Maggiore

Bologna, 40100, Italy

Location

S.Orsola-Malpighi Hospital

Bologna, 40138, Italy

Location

Gastroenterology and Liver Clinic, Azienda Ospedaliero-Universitaria, University of Modena and Reggio Emilia

Modena, Italy

Location

Gastroenterology Unit, Policlinic of Palermo

Palermo, Italy

Location

Internal Medicine Department, Gemelli Hospital, Catholic University of Sacred Heart

Rome, 00168, Italy

Location

Related Publications (1)

• 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.

  PMID: 32716060 DERIVED

MeSH Terms

Conditions

Intrahepatic Cholestasis of Pregnancy; Cholestasis

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Giuseppe Mazzella, Professor

  University of Bologna

  STUDY DIRECTOR

• Francesco Azzaroli, Professor

  University of Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 19, 2010
• First Posted: October 22, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

IT (7)