PHASE III DOUBLE BLIND PLACEBO CONTROLLED RANDOMIZED STUDY ON THE EFFICACY OF URSODEOXYCHOLIC ACID FOR THE TREATMENT OF INTRAHEPATIC CHOLESTASIS OF PREGNANCY - CERTO_01 2008

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-001323-64-IT

Enrollment

112

Registered

2008-03-10

Start date

2008-03-12

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

INTRAHEPATIC CHOLESTASIS OF PREGNANCY MedDRA version: 9.1 Level: LLT Classification code 10049055 Term: Cholestasis of pregnancy

Interventions

Trade Name: URSILON Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ursodeoxycholic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria will be the following: Pregnant state (after week 20 of gestation) Age ≥18 years Informed consent signed Total Serum BA elevations (>10 micromol/l) Transaminases elevations (ALT>19 UI/L and AST>37 UI/L) Occurrence of pruritus Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: The exclusion criteria will be: infectious diseases (HBV, HDV, HCV related liver disease, EBV, CMV, HV infection) dermatologic diseases Patients not able or not willing to follow the procedures of the protocol Patients not signing the informed consent Age<18 years Onset of ICP during of after the 36th week of pregnancy metabolic diseases (including alcohol abuse) Primary biliary cirrhosis Sclerosing Cholangitis 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary aim of the study is to evaluate the efficacy of UDCA treatment: on delivery week (reducing the rate of prematurity) Both spontaneous and therapeutic deliveries induced before week 37 will be considered preterm.;Secondary Objective: Secondary aims are: to evaluate the efficacy of UDCA treatment on maternal biochemical parameters (transaminases and bile acids) and pruritus to evaluate the efficacy of UDCA treatment on the incidence of fetal adverse events (fetal stress, stillbirths, green stained amniotic fluid). to identify indicators of preterm delivery.;Primary end point(s): The primary efficacy variable is preterm delivery	—

Measure

Time frame

Main Objective: The primary aim of the study is to evaluate the efficacy of UDCA treatment: on delivery week (reducing the rate of prematurity) Both spontaneous and therapeutic deliveries induced before week 37 will be considered preterm.;Secondary Objective: Secondary aims are: to evaluate the efficacy of UDCA treatment on maternal biochemical parameters (transaminases and bile acids) and pruritus to evaluate the efficacy of UDCA treatment on the incidence of fetal adverse events (fetal stress, stillbirths, green stained amniotic fluid). to identify indicators of preterm delivery.;Primary end point(s): The primary efficacy variable is preterm delivery

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026