Thalidomide for the Treatment of Primary Sclerosing Cholangitis (PSC)
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|ClinicalTrials.gov Identifier: NCT00953615|
Recruitment Status : Terminated (Lack of enrollment)
First Posted : August 6, 2009
Results First Posted : February 27, 2012
Last Update Posted : February 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Primary Sclerosing Cholangitis||Drug: Thalidomide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label, Phase II Investigation of Thalidomide for the Treatment of Primary Sclerosing Cholangitis|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
Participants will be treated with Thalidomide, starting at a dose of 100 mg per day, increasing the dose by 100 mg every 14 days to a maximum of 400 mg per day.
Titrate to 400 mg daily for 6 months
Other Name: Thalomid
- Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase [ Time Frame: 6 months, baseline ]The primary outcome was the change in serum liver biochemical parameter levels after 6 months of thalidomide when compared to baseline values. This was to be analyzed using the nonparametric Wilcoxon signed rank test of significance. This was based on the non-normal distribution of serum hepatic biochemical parameters among patients with PSC and the continuous nature of these variables.
- Overall Toxicity and Tolerability [ Time Frame: 6 months ]Overall toxicity and tolerability were to be measured by the number of patients with development of neuropathy, increased liver biochemistries, drowsiness, dizziness and orthostatic hypotension.
- Mayo Risk Score [ Time Frame: 6 months ]The Mayo Risk Score estimates the survival probability of a patient with primary sclerosing cholangitis based on the following variables: age, bilirubin, albumin, AST and history of variceal bleeding.
- Soluble Tumor Necrosis Factor - Alpha [ Time Frame: 6 months, baseline ]Assessment of effect from thalidomide on soluble tumor necrosis factor - alpha compared to baseline values were to be performed at study conclusion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00953615
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Keith D Lindor, MD||Mayo Clinic|