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Status unknownNCT01898832Updated Mar 18, 2014

Il-17 Levels in Intrahepatic Cholestasis of Pregnancy

An observational study in Intrahepatic Cholestasis of Pregnancy, sponsored by Zekai Tahir Burak Women's Health Research and Education Hospital. Status unknown at 1 site in Turkey. Open to female participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-18.

Sponsored by Zekai Tahir Burak Women's Health Research and Education Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2013), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 39 Years
Sex
Female
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Study summary

The aim of this study is to investigate maternal and fetal serum IL-17 levels in pregnant women with intrahepatic cholestasis of pregnancy and to find out if Th-17 cells have a role in progress of intrahepatic cholestasis of pregnancy.

Read the detailed description

Intrahepatic cholestasis of pregnancy (ICP) is the most prevalent pregnancy-specific liver disease. It occurs mainly in the second or third trimester of pregnancy. It typically resolves after delivery spontaneously but it is associated with an increased risk of adverse fetal outcomes.

The cause of ICP is heterogeneous, pathophysiology is poorly understood and therapies have been empiric. Genetic predispositions, environmental influences, dietary factors and hormonal influences have been studied and cited in the literature.

Comparing with placebo, ursodeoxycholic acid (UDCA) has been shown improvement in treatment of pruritus in previous studies. S-adenosylmethionine, guar gum, activated charcoal, dexamethasone, cholestyramine, etc. are not effective in the treatment of symptoms.

CD4+ T cells are an essential regulators of immune responses and inflammatory diseases. They are also called chief of orchestra cells of immune system. The balance between T helper-(Th)1, Th-2 and Th-17 cells and their cytokinergic interaction are crucial for the response of the organism. Th17 and its specific cytokine IL-17 are responsible for pathogenesis of autoimmune diseases as autoimmune uveitis, experimental autoimmune encephalomyelitis in animal models and potentially also in human autoimmune diseases such as multiple sclerosis, Crohn's disease, rheumatoid arthritis, psoriasis, primary biliary cirrhosis. Recently, IL-17 targeted therapies (secukinumab, ixekizumab and brodalumab) are being studied in Phase III clinical trials to evaluate their overall efficacy and safety for certain autoimmune diseases.

Th-17 levels have been investigated in normal and abnormal pregnancies and results were incompatible with each other. Some researchers have said that the level of IL-17 increased during pregnancy but the others not.

Low serum IL-17 is associated with premature birth. Up-regulation of the IL-17 is associated with preeclampsia.

K. Harada et all. (2009) demonstrated that IL-17-positive cells are associated with the chronic inflammation of bile ducts in primary biliary cirrhosis(PBC). Also, some authors demonstrated that Th-17-related cytokines were increased significantly in patients with PBC.

Maho Ichikawa et all. presented a case of male newborn infant who showed progressive severe cholestasis with selectively high Levels of Serum IL- 17.

Based on all this information, we decided to investigate maternal and fetal serum IL-17 levels of pregnants with ICP and the effects of UDCA therapy on it and find out if Th-17 cells have a role in progress of ICP.

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Conditions studied

  • Intrahepatic Cholestasis of Pregnancy

Keywords

  • Cholestasis, pregnant, interleukin 17
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In context

Cholestasis

220 studies on the registry are indexed under Cholestasis; 37 are open to participants now.

This study's planned enrollment of 30 is below the median of 100 across 65 observational studies indexed under Cholestasis.

Browse Cholestasis studies →

Lead sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital is the lead sponsor of 62 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The pregnant women with intrahepatic cholestasis who admitted our clinic

Inclusion criteria

Clinical diagnosis of ICP

Exclusion criteria

-

Exclusion Criteria:

multiple pregnancies known chronic illness

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
30 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes
Biospecimen retention
None retained
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What researchers measure

Primary outcomes

  1. il-17 levels

    Time frame: 12 months

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Study locations

1 of 1 sites recruiting
  • Zekai Tahir Burak
    Ankara, 06080, Turkey
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01898832
Lead sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
Responsible party
Ayse Kirbas (ayse kirbas, Zekai Tahir Burak Women's Health Research and Education Hospital) — Principal investigator
First posted
Jul 12, 2013
Start date
Jul 2013
Primary completion
Jun 2014 (estimated)
Completion
Jul 2014 (estimated)
Last update
Mar 18, 2014

Study contacts

ayse kirbas, md
Contact
ayseozdemirkirbas@hotmail.com
+ 90 533 646 92 13
ayse kirbas
Contact
+90 312-306-5000
ayse kirbas, md
principal investigator · Zekai Tahir Burak Women's Health Research and Education Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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