Intrahepatic Cholestasis of PregnancyPhase 3CERTONCT01226823
Ursodeoxycholic Acid And Cholestasis Of Pregnancy
A Phase 3 study testing Ursodeoxycholic Acid in people with Intrahepatic Cholestasis of Pregnancy, run by University of Bologna at 7 sites in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Intrahepatic Cholestasis of Pregnancy
- What is being tested?
- Ursodeoxycholic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 7 sitesItaly
- Study dates
- Nov 2010to Nov 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
UOC Ostetricia e Ginecologia, Ospedale Maggiore
Bologna, 40100
S.Orsola-Malpighi Hospital
Bologna, 40138
Gastroenterology and Liver Clinic, Azienda Ospedaliero-Universitaria, University of Modena and Reggio Emilia
Modena
Dept. of Surgical and Gastroenterological Sciences, University of Padova
Padua, Italy, 34100
Gastroenterology Unit, Policlinic of Palermo
Palermo
Internal Medicine Department, Gemelli Hospital, Catholic University of Sacred Heart
Rome, 00168
Divisione di Gastroenterologia, IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, 71013
About this study
Official title: Intrahepatic Cholestasis Of Pregnancy: Clinical Impact Of Ursodeoxycholic Acid Treatment
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
- Being tested
- Ursodeoxycholic Acid, Placebo
- Keywords
- cholestasis, pregnancy, ursodeoxycholic acid, ICP
- Medical subject headings
- Intrahepatic Cholestasis of Pregnancy, Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursodeoxycholic AcidDrug
300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery
PlaceboDrug
300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | obstetrical monitoring plus placebo Receives: Drug: Placebo |
| Ursodeoxycholic acid | Experimental | obstetrical monitoring plus active drug Receives: Drug: Ursodeoxycholic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with preterm delivery (before week 37)
Measured: at the time of delivery
Secondary outcomes (7)
Pruritus on the Visual Analogue Scale
Measured: from enrollment until delivery
Transaminases
Measured: from enrolment until delivery
Bile Acids
Measured: from enrolment until delivery
Fetal movement count
mother evaluation
Measured: from enrolment until delivery
Number of pregnancies with cardiotocography suggestive of fetal stress
Measured: from enrolment until delivery
APGAR index
Measured: 1 and 5 minutes after birth
Number of pregnancies with Green stained amniotic fluid
obstetrician evaluation
Measured: at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2013 (estimated)
- Study completionNov 2013 (estimated)
Why it stopped: Modified insurance requests by a new law released after its approval.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrahepatic Cholestasis of PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Azzaroli, University of Bologna
- Investigators
- Giuseppe Mazzella, Professor, Study director, University of BolognaFrancesco Azzaroli, Professor, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226823
- Sponsor's protocol ID
- CERTO
- Acronym
- CERTO
- Status last verified
- May 2016
- First submitted
- 19 Oct 2010
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32716060
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrahepatic Cholestasis Of Pregnancy: Clinical Impact Of Ursodeoxycholic Acid Treatment
- ClinicalTrials.gov ID
- NCT01226823
- Acronym / sponsor ID
- CERTO / CERTO
- Conditions
- Intrahepatic Cholestasis of Pregnancy
- Keywords
- cholestasis, pregnancy, ursodeoxycholic acid, ICP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Modified insurance requests by a new law released after its approval.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 22 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placeboobstetrical monitoring plus placebo |
| Ursodeoxycholic acid | Experimental | Drug: Ursodeoxycholic Acidobstetrical monitoring plus active drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ursodeoxycholic Acid300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery | Drug | Ursodeoxycholic acid |
| Placebo300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery | Drug | Placebo |
Primary outcome
Number of participants with preterm delivery (before week 37)
Time frame: at the time of delivery
7 secondary outcomes
Pruritus on the Visual Analogue Scale
Time frame: from enrollment until delivery
Transaminases
Time frame: from enrolment until delivery
Bile Acids
Time frame: from enrolment until delivery
Fetal movement count
Time frame: from enrolment until delivery
Number of pregnancies with cardiotocography suggestive of fetal stress
Time frame: from enrolment until delivery
APGAR index
Time frame: 1 and 5 minutes after birth
Number of pregnancies with Green stained amniotic fluid
Time frame: at delivery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Derived from this study: PubMed 32716060Walker 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.
Related trials for Intrahepatic Cholestasis of Pregnancy
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy
Pregnancy Related
Not yet recruitingPhase 2
MRX-901: An Open-label Study to Assess Safety and Tolerability of Maralixibat in Participants With Intrahepatic Cholestasis of Pregnancy (ICP)
Intrahepatic Cholestasis of Pregnancy
RecruitingObservational study
Bile Acids Metabolism and Genetic Mutation Profile in the Intrahepatic Cholestasis of Pregnacy in Indian Population
Intrahepatic Cholestasis of Pregnancy, Genetic Mutation
Not yet recruiting
The Effect of a Single Intravenous Injection of Esketamine During Cesarean Section on Postoperative Pruritus in Patients With Intrahepatic Cholestasis of Pregnancy
Intrahepatic Cholestasis of Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Mazzella, Professor study director
University of Bologna
Francesco Azzaroli, Professor principal investigator
University of Bologna
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ursodeoxycholic Acid in people with Intrahepatic Cholestasis of Pregnancy, run by University of Bologna at 7 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with preterm delivery (before week 37) (time frame: at the time of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01226823, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.