Status:
WITHDRAWN
Ursodeoxycholic Acid And Cholestasis Of Pregnancy
Lead Sponsor:
University of Bologna
Conditions:
Intrahepatic Cholestasis of Pregnancy
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 leve...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01226823
Start Date
November 1 2010
End Date
November 1 2013
Last Update
May 12 2016
Active Locations (7)
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1
Divisione di Gastroenterologia, IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy, 71013
2
Dept. of Surgical and Gastroenterological Sciences, University of Padova
Padua, Italy, Italy, 34100
3
UOC Ostetricia e Ginecologia, Ospedale Maggiore
Bologna, Italy, 40100
4
S.Orsola-Malpighi Hospital
Bologna, Italy, 40138