Phase I Trial of Silymarin for Chronic Liver Diseases (SyNCH)
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ClinicalTrials.gov Identifier: NCT00389376 |
Recruitment Status :
Completed
First Posted : October 18, 2006
Last Update Posted : February 20, 2008
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Sponsor:
National Center for Complementary and Integrative Health (NCCIH)
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
Tracking Information | |||||||||||||
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First Submitted Date ICMJE | October 16, 2006 | ||||||||||||
First Posted Date ICMJE | October 18, 2006 | ||||||||||||
Last Update Posted Date | February 20, 2008 | ||||||||||||
Study Start Date ICMJE | November 2006 | ||||||||||||
Actual Primary Completion Date | January 2008 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
Adverse events [ Time Frame: 10 days ] | ||||||||||||
Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
Change History | |||||||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title ICMJE | Phase I Trial of Silymarin for Chronic Liver Diseases | ||||||||||||
Official Title ICMJE | Single and Multiple Dose Escalation Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered Silymarin (Legalon) in Non-Cirrhotic Subjects With Chronic Hepatitis C or Non-Alcoholic Fatty Liver Disease | ||||||||||||
Brief Summary | The purpose of this study is to determine the safety and tolerability of different dosages of silymarin on subjects with Hepatitis C or Non-Alcoholic Fatty Liver Disease. | ||||||||||||
Detailed Description | Not Provided | ||||||||||||
Study Type ICMJE | Interventional | ||||||||||||
Study Phase ICMJE | Phase 1 | ||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Schrieber SJ, Hawke RL, Wen Z, Smith PC, Reddy KR, Wahed AS, Belle SH, Afdhal NH, Navarro VJ, Meyers CM, Doo E, Fried MW. Differences in the disposition of silymarin between patients with nonalcoholic fatty liver disease and chronic hepatitis C. Drug Metab Dispos. 2011 Dec;39(12):2182-90. doi: 10.1124/dmd.111.040212. Epub 2011 Aug 24. | ||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||
Actual Enrollment ICMJE |
56 | ||||||||||||
Original Enrollment ICMJE | Same as current | ||||||||||||
Actual Study Completion Date ICMJE | February 2008 | ||||||||||||
Actual Primary Completion Date | January 2008 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE | Inclusion criteria Subjects will be eligible for enrollment in this study if they meet the following criteria:
Exclusion criteria Subjects with any of the following will not be eligible for participation:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Listed Location Countries ICMJE | United States | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT00389376 | ||||||||||||
Other Study ID Numbers ICMJE | U01AT003566-01( U.S. NIH Grant/Contract ) NIH grant # U01-AT0035661 |
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Has Data Monitoring Committee | Yes | ||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||||||||
Responsible Party | SyNCH Steering Committee, NCCAM/NIDDK/UNC/UPenn/TJU/BIDMC/UPitt | ||||||||||||
Study Sponsor ICMJE | National Center for Complementary and Integrative Health (NCCIH) | ||||||||||||
Collaborators ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||||||||||
Investigators ICMJE |
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PRS Account | National Center for Complementary and Integrative Health (NCCIH) | ||||||||||||
Verification Date | February 2008 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |