NCT01576458

Brief Summary

The purpose of this study is to examine the efficacy and safety of ursodeoxycholic acid (UDCA) in the treatment of patients with intrahepatic cholestasis of pregnancy (ICP). In the randomised (double-blind, placebo-controlled) study 20 pregnant women with ICP received (random allocation of) either 450 mg/day UDCA or placebo for 14 days during the third trimester of pregnancy. The severity of pruritus was registered. Itching scores and serum levels of alanine aminotransferase, total bile acids, estradiol, progesterone, prolactin, cholesterol, HDL-cholesterol, triglycerides, activated partial thromboplastin time (APTT), fibrinogen D-dimers (FIDD) and platelet count were assessed before the treatment and weekly thereafter. Data on pregnancy and delivery outcome was recorded and analysed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 1998

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 1998

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1998

Completed
13.2 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 12, 2012

Completed
Last Updated

April 12, 2012

Status Verified

April 1, 2012

Enrollment Period

11 months

First QC Date

February 18, 2012

Last Update Submit

April 11, 2012

Conditions

Intrahepatic CholestasisPregnancy

Keywords

ursodeoxycholic acidintrahepatic cholestasispregnancy

Outcome Measures

Primary Outcomes (2)

  • pruritus

    visual analogy scale (VAS): 0-10

    an average of 5 weeks

  • laboratory values

    Serum levels of alanine aminotransferases and total bile acids were assessed before the treatment and once a week thereafter at least three times or until delivery. Simultaneously serum levels of estradiol, progesterone, prolactin, cholesterol, HDL-cholesterol and triglyserides were assessed. Platelet count activated partial thromboplastin time and fibrinogen D-dimers were measured as well.

    an average 5 weeks

Secondary Outcomes (1)

  • Obstetrical surveillance

    2-12 weeks

Study Arms (2)

ursodeoxycholic acid

ACTIVE COMPARATOR

10 pregant women with intrahepatic cholestasis of pregnancy

Drug: ursodeoxycholic acid

placebo

ACTIVE COMPARATOR

10 pregnant women with intrahepatic cholestasis of pregnancy

Drug: Placebo

Interventions

ursodeoxycholic acidDRUG

450 mg/day for 14 days

ursodeoxycholic acid
PlaceboDRUG

placebo

placebo

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women with intrahepatic cholestasis of pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, 20520, Finland

Location

Related Publications (1)

  • Joutsiniemi T, Timonen S, Leino R, Palo P, Ekblad U. Ursodeoxycholic acid in the treatment of intrahepatic cholestasis of pregnancy: a randomized controlled trial. Arch Gynecol Obstet. 2014 Mar;289(3):541-7. doi: 10.1007/s00404-013-2995-5. Epub 2013 Aug 27.

    PMID: 23978872DERIVED

MeSH Terms

Conditions

Cholestasis, Intrahepatic

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

CholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Deoxycholic AcidCholic AcidsBile Acids and SaltsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholanes

Study Officials

  • Susanna Timonen, PhD

    Turku University Hospital

    STUDY CHAIR

  • Ulla Ekblad, PhD

    Turku University Hospital

    STUDY DIRECTOR

  • Riitta Leino, MD

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

  • Pertti Palo, PhD

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 18, 2012

First Posted

April 12, 2012

Study Start

January 1, 1998

Primary Completion

December 1, 1998

Study Completion

December 1, 1998

Last Updated

April 12, 2012

Record last verified: 2012-04

Locations

FI(1)