the Efficiency of Thalidomide for Recurrent Small Intestinal Bleeding Due to Gastrointestinal Vascular Malformation
Study Details
Study Description
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 |
|---|---|---|
|
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 Design
Arms and Interventions
| 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 Names:
|
| 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 Names:
|
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Participants Whose yearly Rebleeding times Decreased From Baseline by ≥ 50% [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
- difference of patients requiring Blood Transfusions [up to 3 years]
- difference in Total Transfused Red Cell Requirements [up to 3 years]
- The change from baseline in bleeding duration at 12 months [baseline and 12 months]
- difference of average Hemoglobin (Hb) level yearly [up to 3 years]
- difference of patients requiring hospitalization [up to 3 years]
- difference of yearly hospitalization times [up to 3 years]
- difference of the number of days in hospital yearly [up to 3 years]
- percentual reduction in iron requirement [up to 3 years]
- Difference of patients completely cured [up to 3 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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The patients should sign informed consent and be informed of the specific trial plan;
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The patients should have the China nationality;
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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.
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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;
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The patients should present with persistent and recurrent bleeding (>=4 times yearly);
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Hb levels should decreased 10% lower than baseline；
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The patient is willing to comply with the instructions and have the ability to complete the study of research program.
Exclusion Criteria:
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patients associated with varicosity due to cirrhosis of the liver; Or patients with uncontrolled hypertension, uncontrolled hyperglycemia, or other severe diseases;
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patients with a history of severe peripheral neuropathy, seizures, rheumatoid immune disease, or thromboembolic disease;
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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;
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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;
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sustained WBC <3.5 * 109 / L;
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previously small intestinal bowel resection surgery;
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patients are known or suspected allergic to any ingredient to thalidomide;
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serious life-threatening gastrointestinal bleeding requiring immediate surgical treatment;
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patients have used the study drug within 30 days before recruiting;
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alcohol and/or drug abuse, addiction or rely on) or the doctor determine compliance claim;
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patients had been recruited into other clinical research within 6 months;
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personnel related to this study;
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patients have no legal behavior ability or self-knowledge; Or patients refuse into groups.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking Union Medical College Hospital | Beijing | Beijing | China | 100032 |
| 2 | Xinqiao Hospital of Chongqing | Chongqing | Chongqing | China | 400037 |
| 3 | Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | China | 510515 |
| 4 | The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | China | 050000 |
| 5 | Ruijin Hospital | Shanghai | Shanghai | China | 200025 |
| 6 | Shanghai Zhongshan Hospital | Shanghai | Shanghai | China | 200032 |
| 7 | Huashan Hospital | Shanghai | Shanghai | China | 200040 |
| 8 | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai | China | 200092 |
| 9 | Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai | China | 200127 |
| 10 | Changhai Hospital | Shanghai | Shanghai | China | 200433 |
| 11 | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai | China | 201620 |
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
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- rj(2015)088K-a