EUCTR2007-004040-70-GB
Active, not recruiting
Phase 1
Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dr. Falk Pharma GmbH
- Enrollment
- 183
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Signed informed consent
- •2\. Age \= 18 years
- •3\. UDCA treatment for at least 6 months prior to inclusion
- •4\. Liver biopsy compatible with PBC
- •5\. Liver biopsy performed within the last 6 months prior to inclusion
- •6\. PBC patients at risk of disease progression based on one or more of the following criteria:
- •\-PBC patients at risk of disease progression based on one or more of the
- •following criteria:
- •\- Serum alkaline phosphatase \= 3 times upper limit of normal (corresponding to 312 U/L for women and 387 U/L for men) at any time since diagnosis of PBC or
- •\- ALT or AST \= 2 times upper limit of normal (corresponding to 70 U/L for women and100 U/L for men) at inclusion or
Exclusion Criteria
- •1\. Histologically proven cirrhosis
- •2\. Positive Hepatitis B or C serology
- •3\. Positive HIV serology
- •4\. Primary Sclerosing Cholangitis
- •5\. Wilson’s\-Disease
- •6\. Celiac Disease (if not controlled)
- •7\. a1–anti\-Trypsin\-deficiency
- •8\. Haemochromatosis
- •9\. Autoimmune\-Hepatitis (AIH; defined by an Alvarez score \> 15 without treatment or \= 17 with treatment); Note: PBC/AIH overlap disease, treated insufficiently with UDCA monotherapy may be enrolled
- •10\. Treatment with corticosteroids (except inhalative corticosteroids) within the last 2 months prior to inclusion and/or treatment with any of the following drugs within the last 3 months prior to inclusion: colchicine, azathioprine or other immunosuppressive drugs (e.g. cyclosporine, methotrexate), chlorambucil, D\-penicillamine, fibrates, or antihyperlipidemic drugs
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Double-blinded, randomised, placebo-controlled, multicentre , Phase IIa study to investigate the effect efficacy, safety and tolerability of phosphorylcholine human monoclonal antibody (PC-mAb) 3G10 on arterial inflammation, together with safety and tolerability, in subjects with elevated lipoprotein a (Lp[a ])Arterial inflammation in subjects with elevated lipoprotein a (Lp[a])MedDRA version: 20.0Level: LLTClassification code 10051615Term: Atherosclerotic cardiovascular diseaseSystem Organ Class: 100000022953Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2017-002106-13-SEAthera Biotechnologies AB40
Active, not recruiting
Not Applicable
Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBCPatients with Primary Biliary Cirrhosis at risk of disease progressionMedDRA version: 9.1Level: LLTClassification code 10036680Term: Primary biliary cirrhosisEUCTR2007-004040-70-ATDr. Falk Pharma GmbH183
Active, not recruiting
Not Applicable
Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study on the efficacy and tolerability of budesonide capsules versus placebo for maintenance of remission in patients with collagenous colitis - SOIBD Collagenous Colitis Maintenance Study (SCCMS)EUCTR2007-001315-31-CZDr. Falk Pharma GmbH110
Active, not recruiting
Phase 1
Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisPBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liverMedDRA version: 17.0Level: LLTClassification code 10036680Term: Primary biliary cirrhosisSystem Organ Class: 100000004871Therapeutic area: Diseases [C] - Immune System Diseases [C20]EUCTR2007-004040-70-SEDr. Falk Pharma GmbH144
Active, not recruiting
Not Applicable
Study to evaluate the effectiveness and safety of 3 doses ofembryonated eggs of the porcine whipworm compared to placebo(dummy drug) in the treatment of active Crohn's disease.EUCTR2006-000720-13-CZDr. Falk Pharma GmbH400