Ursodeoxycholic Acid And Cholestasis Of Pregnancy | NCT01226823

Studies
Ursodeoxycholic Acid And Cholestasis Of Pregnancy

NCT01226823

Sponsor

University of Bologna

Status

Withdrawn

Last Update Posted

May 12, 2016Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Intrahepatic Cholestasis of Pregnancy

Interventions

Ursodeoxycholic Acid
Placebo

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Modified insurance requests by a new law released after its approval.

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Nov 2013Estimated

Completion Date

Nov 2013Estimated

First Submitted Date

Oct 19, 2010

First Submission Date that Met QC Criteria

Oct 21, 2010

First Posted Date

Oct 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2016

Last Update Posted Date

May 12, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	obstetrical monitoring plus placebo	Drug: Placebo
Ursodeoxycholic acid	Experimental	obstetrical monitoring plus active drug	Drug: Ursodeoxycholic Acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ursodeoxycholic Acid	Drug	300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery	Ursodeoxycholic acid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with preterm delivery (before week 37)		at the time of delivery

Secondary Outcomes

Measure	Description	Time Frame
Pruritus on the Visual Analogue Scale		from enrollment until delivery
Transaminases		from enrolment until delivery
Bile Acids

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Giuseppe Mazzella, Professor	University of Bologna	Study Director
Francesco Azzaroli, Professor	University of Bologna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Divisione di Gastroenterologia, IRCCS Casa Sollievo della Sofferenza		San Giovanni Rotondo	Foggia	71013	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32716060	Derived	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.

ID	Term
D001649	Bile Duct Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases

ID	Term
D003840	Deoxycholic Acid
D002793	Cholic Acids
D001647	Bile Acids and Salts
D013256	Steroids

ID	Term
C535932	Intrahepatic Cholestasis of Pregnancy
D002779	Cholestasis