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the Efficiency of Thalidomide for Recurrent Small Intestinal Bleeding Due to Gastrointestinal Vascular Malformation

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ClinicalTrials.gov Identifier: NCT02707484
Recruitment Status : Recruiting
First Posted : March 14, 2016
Last Update Posted : August 2, 2016
Sponsor:
Collaborators:
Peking Union Medical College Hospital
Nanfang Hospital of Southern Medical University
Xinqiao Hospital of Chongqing
Changhai Hospital
Shanghai Zhongshan Hospital
Huashan Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Ruijin Hospital
The Second Hospital of Hebei Medical University
Information provided by (Responsible Party):
Zhizheng Ge, Shanghai Jiao Tong University School of Medicine

Brief Summary:
Gastrointestinal vascular malformation (GIVM), which is an important cause of acute or chronic gastrointestinal bleeding, currently lacks of effective treatment. The investigators' previous study first confirmed thalidomide treatment of GIVM bleeding was safe and effective. This prospective multi-center randomized controlled clinical trial intends to investigate the efficacy of thalidomide to the recurrent small intestinal hemorrhage due to GIVM.

Condition or disease Intervention/treatment Phase
Gastrointestinal Vascular Malformation Drug: Thalidomide (100mg) Drug: Thalidomide (50mg) Drug: placebo Phase 3

Detailed Description:
This multi-institutional clinical trial investigates the efficacy of thalidomide to the recurrent small intestinal hemorrhage due to GIVM. Patients with annual average bleeding 4 times or more and lesions located in the small intestine which are not suitable for endoscopic therapy will be randomly assigned to receive A(25mg,Thalidomide,qid), B(25mg, Thalidomide, bid& placebo bid ) or placebo(deferred treatment group) for 4 months. The primary endpoints were the difference in yearly bleeding Episodes, followed by the difference in Blood Transfusions, Total Transfused Red Cell Requirements, Bleeding Duration, yearly mean Hemoglobin (Hb) level, hospitalization and iron requirement. After one year follow-up, the treatment of 100mg thalidomide might be paid as supplementary therapy for non-responders if necessary. This study will be done at 10 centers in China.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: the Efficacy of Thalidomide for Recurrent Small Intestinal Bleeding Due to Gastrointestinal Vascular Malformation: a Prospective Multi-center Randomized Controlled Clinical Trial
Study Start Date : March 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Thalidomide

Arm Intervention/treatment
Experimental: Thalidomide Group(100mg) Drug: Thalidomide (100mg)
Patients were randomly assigned to receive a four-month course of 100 mg of thalidomide (Pharmaceutical Co., Ltd. of ChangZhou, China).
Other Name: Group 1

Experimental: Thalidomide Group(50mg) Drug: Thalidomide (50mg)
Patients were randomly assigned to receive a four-month course of 50 mg of thalidomide (Pharmaceutical Co., Ltd. of ChangZhou, China).
Other Name: Group 2

Placebo Comparator: placebo -controlled Group Drug: placebo
Patients were randomly assigned to receive a four-month course of placebo (Pharmaceutical Co., Ltd. of ChangZhou, China).
Other Name: Group 3




Primary Outcome Measures :
  1. Participants Whose yearly Rebleeding times Decreased From Baseline by ≥ 50% [ Time Frame: Baseline and 12 months ]
    The primary end point was defined as the patients whose rebleeds decreased 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 was defined based on a positive fecal occult blood test (FOBT) (monoclonal colloidal gold color technology) at any visit after treatment.


Secondary Outcome Measures :
  1. difference of patients requiring Blood Transfusions [ Time Frame: up to 3 years ]
  2. difference in Total Transfused Red Cell Requirements [ Time Frame: up to 3 years ]
  3. The change from baseline in bleeding duration at 12 months [ Time Frame: baseline and 12 months ]
  4. difference of average Hemoglobin (Hb) level yearly [ Time Frame: up to 3 years ]
  5. difference of patients requiring hospitalization [ Time Frame: up to 3 years ]
  6. difference of yearly hospitalization times [ Time Frame: up to 3 years ]
  7. difference of the number of days in hospital yearly [ Time Frame: up to 3 years ]
  8. percentual reduction in iron requirement [ Time Frame: up to 3 years ]
  9. Difference of patients completely cured [ Time Frame: up to 3 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patients should sign informed consent and be informed of the specific trial plan;
  • The patients should have the China nationality;
  • The patients should be aged from 18 to 70 years old, male or female; Patients must agree to follow acceptable birth control such as physical intrauterine contraceptive ring or use a condom. Female with the potential for pregnancy need to have a negative serum or urine pregnancy test prior to treatment.
  • The intestinal vascular lesions should be found by capsule endoscopy, and / or balloon assisted enteroscopy; OR the patients should present with persistent and recurrent bleeding, while the bleeding lesions are unable to be located after initial negative results on endoscopic evaluation by upper GI endoscopy, colonoscopy and CTE;
  • The patients should present with persistent and recurrent bleeding (>=4 times yearly);
  • Hb levels should decreased 10% lower than baseline;
  • The patient is willing to comply with the instructions and have the ability to complete the study of research program.

Exclusion Criteria:

  • patients associated with varicosity due to cirrhosis of the liver; Or patients with uncontrolled hypertension, uncontrolled hyperglycemia, or other severe diseases;
  • patients with a history of severe peripheral neuropathy, seizures, rheumatoid immune disease, or thromboembolic disease;
  • patients with indications which should constantly use non-steroidal anti-inflammatory drugs, anticoagulants and antiplatelet or acetyl salicylic acid preparation, ginkgo, Echinacea, Chinese herbal medicine composition, other anti-angiogenesis drugs;
  • patients with malignant or severe heart disease (uncontrolled angina and/or myocardial infarction, congestive heart failure within 3 months before recruiting, etc.), lung disease (respiratory failure), kidney (Cr, BUN 2 times more than normal ceiling), pancreatic, liver disease(severe liver function damage 2 times more than normal ALT, AST, TBIL cap) or other diseases that researchers evaluated as affect the judgment of the treatment;
  • sustained WBC <3.5 * 109 / L;
  • previously small intestinal bowel resection surgery;
  • patients are known or suspected allergic to any ingredient to thalidomide;
  • serious life-threatening gastrointestinal bleeding requiring immediate surgical treatment;
  • patients have used the study drug within 30 days before recruiting;
  • alcohol and/or drug abuse, addiction or rely on) or the doctor determine compliance claim;
  • patients had been recruited into other clinical research within 6 months;
  • personnel related to this study;
  • patients have no legal behavior ability or self-knowledge; Or patients refuse into groups.

Information from the National Library of Medicine

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): NCT02707484


Contacts
Contact: Zhizheng Ge, MD, Ph D zhizhengge@aliyun.com

Locations
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100032
Contact: Yan Xuemin    18612247293    pumchyxm@sina.com   
China, Chongqing
Xinqiao Hospital of Chongqing Not yet recruiting
Chongqing, Chongqing, China, 400037
Contact: Xie Xia    13452166767    xiexia@163.com   
China, Guangdong
Nanfang Hospital of Southern Medical University Not yet recruiting
Guangzhou, Guangdong, China, 510515
Contact: Li Yue    15975537291    liyue_1989919@126.com   
China, Hebei
The Second Hospital of Hebei Medical University Recruiting
Shijiazhuang, Hebei, China, 050000
Contact: Liu li         
China, Shanghai
Ruijin Hospital Recruiting
Shanghai, Shanghai, China, 200025
Contact: Fan Rong    13661757972    rong_de_fan@yahoo.fr   
Shanghai Zhongshan Hospital Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: Shen Xizhong    13877783888      
Huashan Hospital Recruiting
Shanghai, Shanghai, China, 200040
Contact: Zhong Liang    13901657183    zhongniping@163.com   
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200092
Contact: Xu Leiming    13651686398    LeiMing.Xu@aliyun.com   
Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200127
Contact: Zhizheng Ge, MD. Ph.D    18621890923    zhizhengge@aliyun.com.cn   
Principal Investigator: Zhizheng Ge, MD. Ph.D         
Changhai Hospital Not yet recruiting
Shanghai, Shanghai, China, 200433
Contact: Wang Dong    13817655762    dr.dongwang@qq.com   
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Not yet recruiting
Shanghai, Shanghai, China, 201620
Contact: Lu Lungen    13381616206    lungenlu1965@163.com   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Peking Union Medical College Hospital
Nanfang Hospital of Southern Medical University
Xinqiao Hospital of Chongqing
Changhai Hospital
Shanghai Zhongshan Hospital
Huashan Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Ruijin Hospital
The Second Hospital of Hebei Medical University

Publications of Results:

Responsible Party: Zhizheng Ge, Director of digestive endoscopy center of Renji hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02707484     History of Changes
Other Study ID Numbers: rj(2015)088K-a
First Posted: March 14, 2016    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: July 2016

Keywords provided by Zhizheng Ge, Shanghai Jiao Tong University School of Medicine:
Gastrointestinal vascular malformation
thalidomide
Small intestinal bleeding

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Congenital Abnormalities
Vascular Malformations
Pathologic Processes
Cardiovascular Abnormalities
Cardiovascular Diseases
Gastrointestinal Diseases
Digestive System Diseases
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents