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IdB 1016 Treatment for Hepatitis C Disease Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about IdB 1016 Treatment for Hepatitis C Disease conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. IdB 1016 Treatment for Hepatitis C Disease Clinical research trials and IdB 1016 Treatment for Hepatitis C Disease health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including IdB 1016 Treatment for Hepatitis C Disease. IdB 1016 Treatment for Hepatitis C Disease Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a IdB 1016 Treatment for Hepatitis C Disease clinical trial. Test subjects typically receive the most expert healthcare available for their IdB 1016 Treatment for Hepatitis C Disease condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > IdB 1016 Treatment for Hepatitis C Disease  IdB 1016 Treatment for Hepatitis C Disease
IdB 1016 Treatment for Hepatitis C Disease
For Condition: Hepatitis C, Chronic
Status: Recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: This study will measure the safety and tolerability of three different doses of IdB 1016 in patients with hepatitis C disease who have not responded to or are poor candidates for interferon-based therapies. NOTE: THE STUDY WILL ONLY RECRUIT STUDY PARTICIPANTS AT UNIVERSITY OF WASHINGTON MEDICAL CENTER IN SEATTLE
Details: Results from two open label and four randomized placebo-controlled studies in patients with liver disease of diverse etiology suggest that IdB 1016 (oral silybin-phosphatidylcholine phytosome) is well tolerated and significantly improves serum liver enzyme levels. However, IdB 1016 dosing in these studies ranged from 314 mg bid to 314 mg tid, which is below Phase I doses that were well tolerated in healthy volunteers. None of the studies tested the safety and efficacy of IdB 1016 strictly in patients with chronic hepatitis C disease or measured post-treatment histologic changes. This study will be an open label, randomized, dose-finding study. There will be three arms corresponding to three different IdB 1016 doses: 314 mg, 624 mg, and 942 mg tid. Each arm will have 15 patients diagnosed with chronic hepatitis C and will be stratified to five patients with fibrosis stage II (periportal fibrosis), five patients with fibrosis stage III (bridging fibrosis), and five patients with fibrosis stage IV (compensated cirrhosis). The treatment duration will be 12 weeks. Patients will be followed for an additional 4 weeks after treatment cessation to assess residual effects of measured parameters. Patients will have clinic visits on Day -21 (screening), Day 1 (treatment initiation), Day 29, Day 57, Day 85 (end of treatment), and Day 113 (follow-up after washout).
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - HCV infection according to ELISA-2 - Detectable HCV RNA PCR as measured within the previous 6 months - Poor responders to, inadequate candidates for, or unwilling to use interferon-based therapies - Serum ALT >= 1.3 times above normal - Persistently elevated serum ALT levels according to two measures in the previous 12 months - Evidence of stage II (periportal fibrosis), III (bridging fibrosis), or IV (compensated cirrhosis) in the Batts-Ludwig scoring system according to a liver biopsy performed in the last 2 (stage II and III patients) to 5 (stage IV patients) years - Able and willing to follow protocol directions for the duration of the study - Able and willing to maintain a consistent lifestyle routine (e.g., diet, exercise, medications, and dietary supplements) and sleep schedule for the duration of the study - Able and willing to stop taking dietary supplements outside the study protocol for the duration of the study - Able and willing to practice two methods of contraception during the study period, including the 4 week follow-up. This applies to women with childbearing potential and men whose sexual partners have childbearing potential. Exclusion Criteria: - Pregnant or breastfeeding - Liver synthetic dysfunction (albumin < 3.2 g/dL, total bilirubin > 3.0 mg/dL, prothrombin time > 1.5 seconds prolonged) - History of portal hypertension, ascites, variceal bleeding, encephalopathy, jaundice, or extrahepatic biliary obstruction - History of uncontrolled diabetes mellitus - Known concomitant acute or chronic viral liver infections (e.g., hepatitis A, hepatitis B, Epstein-Barr, or cytomegalovirus) - Concomitant autoimmune and inflammatory disease (e.g., rheumatoid arthritis, lupus) - Other types of concomitant liver disease - HIV-1 coinfection - Chronic use of hepatotoxic drugs (e.g., acetaminophen) - Interferon-based therapies in the past 6 months - Alcohol consumption within 3 months prior to entry. Patients with a history of alcohol abuse should be at least 2 years into recovery. - Use of recreational oral or IV drugs. Patients with a history of drug addiction should be at least 2 years into recovery. - History of untreated malignancy - Remission from previous malignant neoplasms <= 6 months - History of significant renal, endocrine, cardiac, or pulmonary disease - Use of supplements containing compounds derived from milk thistle - Proven allergy to milk thistle or any derived compounds - Subjects taking warfarin or coumadin due to silybin's potential interactions with cytochrome CYP 29C - Any condition or concomitant medication or supplement that could hinder the outcomes of the study or the safety of the patient as determined by the principal investigator
Total Enrollment: 45
Location and Contact Information:
Overall Study Official:
KrisKowdley, Principal Investigator, University of Washington
University of Washington Medical Center *Recruiting*
Seattle, Washington, 98105
United States
Recruiting Kris Kowdley 206-598-2076
Additional Information:
Study ID Numbers: 1 R21 AT00992-01A1; IdB-1016-UW-001
Study Start Date: November 2003
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055445
Other Hepatitis C, Chronic Studies:
1. IdB 1016 Treatment for Hepatitis C Disease
2. Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin
3. Addition of ISIS 14803 to therapy with peginterferon and ribavirin for chronic HCV patients not responding adequately to the two drugs.
4. Evaluating Silymarin for Chronic Hepatitis C
5. ISIS 14803-CS2, Treatment with ISIS 14803, Administered IV in Patients with Chronic Hepatitis C Virus Infections
Related Studies:
Other Hepatitis C, Chronic Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
IdB 1016 Treatment for Hepatitis C Disease
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