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Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis Clinical research trials and Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis. Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis clinical trial. Participants oftentimes recieve the finest healthcare available for their Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis  Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis
Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis
For Condition: Cystic Fibrosis
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development , Children's Hospital Medical Center - Cincinnati
Synopsis: OBJECTIVES: I. Determine the optimum dose of tauroursodeoxycholic acid (TUDCA) required to achieve maximal bioavailability for patients with cystic fibrosis-associated liver disease. II. Compare optimized doses of TUDCA with ursodiol (ursodeoxycholic acid; UDCA) for effects on biliary bile acid composition and metabolism, serum biochemistries, fat absorption, and fat-soluble vitamin status in these patients.
Details: PROTOCOL OUTLINE: Objective I: This part of the study is a dose-response study to determine the optimal dose of tauroursodeoxycholic acid (TUDCA). Twenty-four patients are randomized to receive one of three different doses of TUDCA for 3 months. Objective II: This part of the study is a double-blind crossover study to compare optimized doses of TUDCA with optimized doses of ursodiol in 15 patients stratified according to age (less than 10 vs 10-20 vs more than 20 years). Patients are randomized to receive either TUDCA or ursodiol orally for an initial 3 month period, followed by a 3 month washout period in which no drug is administered. Patients then receive the alternate drug for 3 months.
Eligibility:
Study Type: Interventional, Treatment, Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Cystic fibrosis-associated liver disease, defined by at least one of the following criteria: (1) Documented increase in serum concentrations of any of the liver enzymes (at least once in the preceding year) ALT at least twice normal AST at least 1.5 times normal Alkaline phosphatase at least 1.5 times normal GGT at least 1.5 times normal (2) Persistent hepatomegaly of more than 6 months duration defined by percussed liver span greater than 1 SEM for age (3) Splenomegaly, defined as a palpable spleen greater than 2.0 cm below the left costal margin (4) Abnormalities of ultrasound scan (increased size, dishomogeneous echogenicity, nodular liver, irregular margins, splenomegaly) within 6 months prior to study entry - Patients enrolled in the first part of the study (objective I) are eligible to participate in the second part (objective II) --Prior/Concurrent Therapy-- - At least 3 months since prior ursodiol - At least 3 months since treatment with drug with choleretic properties or effects that influence bile acid metabolism --Patient Characteristics-- - Hepatic: No decompensated cirrhosis No hepatic neoplasm or cholelithiasis - Pulmonary: No significantly impaired pulmonary function with FEV1 less than 50% - Other: At least 15 kg body weight No severely compromised clinical or nutritional state
Total Enrollment: 39
Location and Contact Information:
Overall Study Official:
KennethSetchell, Study Chair, Children's Hospital Medical Center - Cincinnati
University of Milan *Recruiting*
Milan, , 20122
Italy
Recruiting Carla Colombo 2-8-912-9975
Children's Hospital Medical Center - Cincinnati *Recruiting*
Cincinnati, Ohio, 45229-3039
United States
Recruiting Kenneth Setchell 513-636-4548
Children's Hospital of Denver *Recruiting*
Denver, Colorado, 80218
United States
Recruiting Michael Narkowicz 303-861-6669
Additional Information:
Study ID Numbers: 199/13439; CHMC-C-001439,CHMC-C-96-1-8,CHMC-C-FDR001439-01
Study Start Date: September 1997
Record last reviewed: July 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004441
Other Cystic Fibrosis Studies:
1. Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease
2. Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol with Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease
3. Phase III Randomized Study of the Inhalation of Tobramycin in Patients with Cystic Fibrosis
4. Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis
5. Safety and Efficacy of Recombinant Adeno-Associated Virus containing CFTR in the treatment of Cystic Fibrosis
Related Studies:
Other Cystic Fibrosis Clinical Trials
Other Colorado Clinical Trials
Other Denver Clinical Trials
Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis
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