EUCTR2007-004040-70-SE
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
ConditionsPBC 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]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- PBC 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 liver
- Sponsor
- Dr. Falk Pharma GmbH
- Enrollment
- 144
- Status
- Active, not recruiting
- Last Updated
- 8 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 start of baseline examinations
- •4\. Liver biopsy compatible with PBC and assessed with inflammatoryactivity according to the mHAI score, Ishak et al.,
- •5\. Liver biopsy performed within the last 6 months prior to start of baseline examinations
- •6\. PBC 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 according to the mHAI sum score (Ishak et al., 1995\) in the histological assessment of the liver
- •7\. Type 2 anti\-mitochondrial antibodies \> 1:40 by indirect immunofluorescence
- •8\. Women of child\-bearing potential have to apply appropriate contraceptive methods, e.g., hormonal contraception, intrauterine device (IUD), double\-barrier method of contraception (e.g., use of a condom and spermicide), partner has undergone vasectomy and subject is in monogamous relationship. The investigator is responsible for determining whether the subject has adequate birth control for study participation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
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) and immunosuppressants within the last 2 months prior to start of baseline examinations
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
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)Collagenous colitisMedDRA version: 8.1 Level: LLT Classification code 10048928 Term: Colitis collagenousEUCTR2007-001315-31-BEDr. Falk Pharma GmbH92
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)Collagenous colitisMedDRA version: 13.1Level: PTClassification code 10048928Term: Colitis collagenousSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2007-001315-31-DKDr. Falk Pharma GmbH110
Active, not recruiting
Not Applicable
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: 18.0Level: LLTClassification code 10036680Term: Primary biliary cirrhosisSystem Organ Class: 100000004871Therapeutic area: Diseases [C] - Immune System Diseases [C20]EUCTR2007-004040-70-LTDr. Falk Pharma GmbH144
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)Collagenous colitisMedDRA version: 14.1Level: LLTClassification code 10048928Term: Colitis collagenousSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2007-001315-31-DEDr. Falk Pharma GmbH110
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.Induction of remission in active Crohn´s diseaseMedDRA version: 14.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]EUCTR2006-000720-13-DKDr. Falk Pharma GmbH400