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02 September 2010
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| [ Print-friendly version ] |
| Study of INT-747 in combination with ursodeoxycholic acid (UDCA [URSO®]) in patients with primary biliary cirrhosis (PBC) |
| ISRCTN | ISRCTN67465025 |
| ClinicalTrials.gov identifier | NCT00550862 |
| Public title | Study of INT-747 in combination with ursodeoxycholic acid (UDCA [URSO®]) in patients with primary biliary cirrhosis (PBC) |
| Scientific title | A study of INT-747 (6-ethyl chenodeoxycholic acid [6-ECDCA]) in combination with ursodeoxycholic acid (UDCA [URSO®]) in patients with primary biliary cirrhosis (PBC) |
| Acronym | N/A |
| Serial number at source | 747-202 |
| Study hypothesis | The primary hypothesis is that INT-747 will cause a reduction in alkaline phosphatase (AP) levels in primary biliary cirrhosis (PBC) patients, over a 12 week treatment period, as compared to placebo. |
| Ethics approval |
Ethics approval received from:
1. USA: Institutional Review Board, Beth Israel Medical Centre on the 2nd October 2007 (ref: 133-07) 2. Canada: University of Toronto, University Health Network Research Ethics Board on the 10th June 2008 (ref: 07-0624-A) Ethics approval received from (as of 09/12/2009): 3. Austria: Ethikkommission der Medizinischen Universität Graz on the 1st October 2008 (ref: 19-316 ex 07/09) 4. France: CPP Ile de France VI on the 27th October 2008 (ref: 85-08) 5. Germany: Ethik-Kommission der Medizinischen Hochschule Hannover on the 17th December 2008 (ref: 5162M) 6. Spain: Comitè Ètic Investigació Clínica on the 19th September 2008 (ref: 747-202) Ethics approval pending from: 7. UK: Multicentre Research Ethics Committee (MREC) 8. The Netherlands 9. Italy All other centres within recruiting countries will seek ethics approval before recruiting participants. |
| Study design | Treatment, randomised, double blind (subject, investigator), placebo controlled, parallel assignment, safety/efficacy study |
| Countries of recruitment | Austria, Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States of America |
| Disease/condition/study domain | Primary biliary cirrhosis |
| Participants - inclusion criteria |
1. Male or female age 18 to 70 years
2. Stable dose of ursodeoxycholic acid (UDCA [URSO®]) for at least six months prior to screening 3. Female patients must be post-menopausal, surgically sterile, or prepared to use two methods of contraception with all sexual partners during the study and for 14 days after the end of dosing 4. Male patients must be prepared to use two methods of contraception with all sexual partners during the study and for 14 days after the end of the dosing 5. Proven or likely PBC, as demonstrated by the patient presenting with at least two of the following three diagnostic factors: 5.1. History of increased AP levels for at least 6 months prior to Day 0 5.2. Positive antimitochondrial antibody (AMA) titre (greater than 1:40 titre on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay [ELISA]) or PBC-specific antinuclear antibodies (antinuclear dot and nuclear rim positive) 5.3. Liver biopsy consistent with PBC 6. Screening AP value between 1.5 and 10 x upper limit of normal (ULN) |
| Participants - exclusion criteria |
1. Administration of the following drugs at any time during the three months prior to screening for the study:
1.1. Colchicine 1.2. Methotrexate 1.3. Azathioprine 1.4. Systemic corticosteroids 2. Screening conjugated (direct) bilirubin greater than 2 x ULN 3. Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 5 x ULN 4. Screening serum creatinine greater than 133 µmol/L (1.5 mg/dL) 5. History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites) 6. History or presence of other concomitant liver diseases including hepatitis due to hepatitis B or C virus (HBV, HCV) infection, primary sclerosing cholangitis (PSC), alcoholic liver disease, definite autoimmune liver disease or biopsy proven nonalcoholic steatohepatitis (NASH) 7. Pregnancy |
| Anticipated start date | 01/11/2007 |
| Anticipated end date | 01/12/2008 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the sponsor details below to request a patient information sheet |
| Target number of participants | 140 |
| Interventions |
1. Experimental treatment: INT-747 10 mg orally po once daily (QD)
2. Experimental treatment: INT-747 25 mg po QD 3. Experimental treatment INT-747 50 mg po QD 4. Matched placebo comparator: placebo po QD Screening can last up to 4 weeks. Treatment is 12 weeks. Follow up after treatment is 2 weeks. Ursodeoxycholic acid (UDCA) treatment is prescribed by each patient's physician; the UDCA dose and timing of its administration each day is determined by each patient's physician (not by the protocol). |
| Primary outcome measure(s) |
To assess the effects of INT-747 on:
1. Alkaline phosphatase (AP) levels 2. Safety Time frame: 12 weeks |
| Secondary outcome measure(s) |
1. To assess the effects of INT-747 on:
1.1. Hepatocellular injury and liver function 1.2. Disease-specific and general health symptoms 1.3. Biomarkers of hepatic inflammation and fibrosis 2. Plasma trough concentrations of INT-747 and its major, known metabolites Time frame: 12 weeks |
| Sources of funding |
1. Genextra S.p.A. (Italy)
2. Visium (USA) 3. JAFCO Life Science Investment (Japan) |
| Trial website | |
| Publications | |
| Contact name | Dr Erin Castelloe |
| Address |
Clinical Consultant - Pharmacovigilance
4370 La Jolla Village Drive Suite 1050 |
| City/town | San Diego |
| Zip/Postcode | 92122 |
| Country | United States of America |
| Tel | +1 858 354 6441 |
| Fax | +1 858 225 0335 |
| ecastelloe@interceptpharma.com | |
| Sponsor | Intercept Pharmaceuticals (USA) |
| Address |
4370 La Jolla Village Drive
Suite 1050 |
| City/town | San Diego |
| Zip/Postcode | 92122 |
| Country | United States of America |
| Tel | +1 858 652 6800 |
| Fax | +1 858 558 5961 |
| csciacca@interceptpharma.com | |
| Sponsor website: | http://www.interceptpharma.com |
| Date applied | 03/07/2008 |
| Last edited | 09/12/2009 |
| Date ISRCTN assigned | 13/08/2008 |
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| © 2010 ISRCTN unless otherwise stated. | |
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