Retreatment and Its Efficiency of Thalidomide for Vascular Malformation Patients With Failure of First Course Treatment
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|ClinicalTrials.gov Identifier: NCT02301949|
Recruitment Status : Withdrawn
First Posted : November 26, 2014
Last Update Posted : April 21, 2016
Background: Repeated episodes of bleeding from gastrointestinal vascular malformations refractory to endoscopic or surgical therapy often pose a major therapeutic challenge.
Methods: The investigators will perform a randomized, double blind, placebo controlled study of thalidomide as a retreatment therapy for recurrent gastrointestinal bleeding due to vascular malformation. Patients with failure of first course treatment of thalidomide will be randomly grouped, prescribed a second four-month course regimen of 25 mg of thalidomide or placebo orally four times daily. All patients will be monitored for at least one year. The primary end point is defined as the patients whose rebleeds decrease from baseline by ≥ 50% at 12 months and the cessation of bleeding. Rebleeding is defined based on a positive fecal occult blood test (FOBT) (monoclonal colloidal gold color technology) at any visit after treatment. Secondary outcomes include the participants dependent on blood transfusions and changes from baseline in transfused packed red cell units, bleeding episodes, and hemoglobin levels at 12 months. Statistical significance is defined at P < 0.05.
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Bleeding of Unknown Origin Gastrointestinal Vascular Malformation Thalidomide Efficiency||Drug: Thalidomide Other: Placebo||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Study of the Optimal Treatment Strategy for Patients With Gastrointestinal Bleeding Due to Gastrointestinal Vascular Malformation: a Randomized, Double Blind, Placebo Controlled Study|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2018|
|Active Comparator: Thalidomide Retreatment Group||
Patients are randomly assigned to receive a second course of four-month treatment of thalidomide (Pharmaceutical Co., Ltd. of ChangZhou, China). Medications are taken orally 25mg four times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m.
Other Name: Softenon
|Placebo Comparator: Placebo Group||
Patients are randomly assigned to receive placebo tablets (Pharmaceutical Co., Ltd. of ChangZhou, China) four times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m.
- The primary end point is defined as the patients whose rebleeds decrease from baseline by ≥ 50% at 12 months [ Time Frame: 12 months ]The primary end point is defined as the patients whose rebleeds decrease from baseline by ≥ 50% at 12 months. Reduction of rebleeds = [(total bleeding episode at 12 months - total bleeding episodes at a year before randomization)/total bleeding episodes at a year before randomization(baseline)]*100%. Rebleeding is defined based on a positive fecal occult blood test (FOBT) (monoclonal colloidal gold color technology) at any visit after treatment.
- Change From Baseline in Hemoglobin (Hb) Level at 12 Months [ Time Frame: 12 months ]The change from baseline in average hemoglobin (Hb) level(tested every month) at 12 months.
- Change From Baseline in Bleeding Episodes at 12 Months [ Time Frame: 12 months ]The Change from baseline in bleeding episodes at 12 months
- Participants Dependent on Blood Transfusions [ Time Frame: 12 months ]Numbers of participants dependent on blood transfusions
- Change From Baseline in Total Transfused Red Cell Requirements at 12 Months [ Time Frame: 12 months ]Change of total transfused red cell requirements at 12 months after randomization from one year before baseline in transfusion dependent patients
- Cessation of Bleeding [ Time Frame: 12 months ]The cessation of bleeding is defined as repeated negative faecal occult blood test (FOBT) (monoclonal colloidal gold color technology) during our observation period. Rebleeding is defined based on a positive FOBT at any visit after treatment.
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): NCT02301949
|Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine|
|Shanghai, Shanghai, China, 200127|
|Principal Investigator:||Zhizheng Ge, MD. Ph.D||Shanghai Ren Ji Hospital|