Primary biliary cholangitis MedDRA version: 21.0 Level: PT Classification code 10080429 Term: Primary biliary cholangitis System Organ Class: 10019805 - Hepatobiliary disorders
Conditions
Interventions
Product Name: RhuDex 25 mg (31.75 mg RhuDex choline salt) granules
Pharmaceutical Form: Gastro-resistant granules
INN or Proposed INN: RhuDex choline salt
Current Sponsor code: RhuDex choline salt
Con
Sponsors
Dr. Falk Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient is able to understand the information on the trial and has signed the informed consent form, - Male or female patients = 18 and =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - History or presence of other relevant concomitant liver diseases - Liver cirrhosis - History or presence of hepatic decompensation (e.g. variceal bleeding hepatic encephalopathy or poorly controlled ascites), - Serum albumin less than 3.2 g/dL, at screening, - Any known relevant infectious disease (e.g. active tuberculosis, acquired immunodeficiency syndrome [AIDS]-defining diseases), - Abnormal renal function (glomerular filtration rate estimated from cystatin C ULN at screening (elevated levels [4.2-10 µU/mL] are acceptable if free thyroxine 4 (fT4) is measured and within the normal range), - Current history of significant alcohol consumption (> 30 g/day in men, > 20 g/day in women on average) for a period of more than 3 consecutive months within 1 year prior to screening, - Any illness or medical conditions that are unstable or could jeopardise the safety of the patient and his/her compliance in the trial or might interfere with the trial results, - Previous and concurrent HIV infection, - Previous or concurrent cancer except cervical carcinoma in situ, treated basal cell carcinoma, or any cancer curatively treated < 3 years before trial entry, - Existing or intended pregnancy or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of 3 doses of RhuDex vs placebo for the treatment of PBC in patients with an inadequate response to UDCA.;Secondary Objective: - To identify efficacious RhuDex dose(s) for the treatment of PBC for further evaluation in phase III - To study safety and tolerability of RhuDex;Primary end point(s): Primary Efficacy Endpoint: • Relative change (%) in Alkaline phosphatase (ALP) from baseline to End Of Trial (EoT). --- Safety Endpoints: • Adverse Events, • Vital signs (blood pressure, heart rate), body temperature, body weight and BMI, • Haematology, serum chemistry, urinalysis, coagulation, • ECG parameters (12 leads), • Patient’s tolerability of the IMP. ;Timepoint(s) of evaluation of this end point: Throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints: - ALP at each trial visit (screening to follow-up), - Absolute and relative changes (%) of ALP from baseline to each visit up to EOT, and from EOT to the follow-up visit, - ?-GT, AST, ALT, and total and conjugated bilirubin levels at each trial visit (screening to follow-up), - Absolute and relative changes (%) of ?-GT, AST, ALT and total and conjugated bilirubin levels from baseline to each visit up to EOT, and from EOT to the follow-up visit. ;Timepoint(s) of evaluation of this end point: Throughout the study | — |
Countries
Belgium, Germany, Hungary, Italy, Netherlands, Poland, Slovakia, United Kingdom
Contacts
Public ContactHeadquarters
Dr. Falk Pharma GmbH
Outcome results
None listed