Gastrointestinal Vascular MalformationPhase 3NCT02707484
the Efficiency of Thalidomide for Recurrent Small Intestinal Bleeding Due to Gastrointestinal Vascular Malformation
A Phase 3 study testing Thalidomide (100mg) and Thalidomide (50mg) in people with Gastrointestinal Vascular Malformation, run by Shanghai Jiao Tong University School of Medicine at 10 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Vascular Malformation
- What is being tested?
- Thalidomide (100mg) and Thalidomide (50mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 10 sitesChina
- Study dates
- Apr 2016to Apr 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects voluntarily signed the informed consent after the nature and the specific procedures of the trial has been verbally explained; they have the opportunity to ask questions.
- Chinese nationality;
- Female or male subjects aged 18-75 years. Female subjects must be menopausal or have undergone sterilization such as tubal ligation and hysterectomy, or have no plan to give birth recently and agree to take contraceptive measures such as contraceptive drugs, intrauterine physical birth control rings or contraception condoms; or men must have undergone sterilization or do not plan to have a child recently and agree to take contraceptive measures such as contraceptive drugs, or contraception condoms. These criteria are set to eliminate the risk of subjects of child bearing potential.
- The subjects must have been diagnosed, by capsule endoscopy and / or balloon-assisted enteroscopy, with small intestinal vascular malformation lesions which are unsuitable or inaccessible to endoscopic therapy or surgical antrectomy. Subjects with persistent, recurrent bleeding, ≥ 4 episodes of overt or occult bleeding over last year.
Who cannot join
- Subjects with esophageal varices from cirrhosis of the liver; those with uncontrolled hypertension or hyperglycemia (or diabetics who are being treated with insulin), or those with severe heart (e.g., uncontrolled angina pectoris and / or myocardial infarction, congestive heart failure, etc.), respiratory failure, or renal failure with creatinine (Cr) or blood urea nitrogen (BUN) > 2 times the upper limit of normal (ULN), pancreatic or hepatic disease with abnormal hepatic function with alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin (TBil) > 2 times ULN 3 months before the enrollment, or those with any other diseases that are not suitable for the study as judged by the Investigator;
- Subjects with a history of severe peripheral neuropathy or seizures, or a history of thromboembolic disease;
- Subjects who need to continuously use non-steroidal anti-inflammatory drugs, anticoagulants, antiplatelets, acetylsalicylic acid preparations, or Chinese herbal medicines containing ginkgo and echinacea; or those who need to receive other anti-angiogenic drugs for a long time;
- Subjects with white blood cell counts persistently <3.5 * 10^9 / L;
- Subjects with a history of small bowel resection;
- Subjects known or suspected to be allergic to any component of thalidomide；
Show all 11Show fewer
- Subjects with severe gastrointestinal bleeding that is life-threatening and requires immediate surgical treatment;
- Subjects who have previously received thalidomide for gastrointestinal bleeding 30 days before the enrollment;
- Alcohol and / or substance abusers with addiction or dependence, or those with poor compliance as judged by a doctor;
- Subjects who participated in other clinical trial 6 months before enrollment;
- Subjects without legal capacity or self-awareness.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Xinqiao Hospital of Chongqing
Chongqing, Chongqing Municipality, 400037
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Huashan Hospital
Shanghai, Shanghai Municipality, 200040
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 201620
About this study
Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study of Efficacy of Thalidomide for Refractory Small Intestinal Bleeding From Vascular Malformation
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.
Read the 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 effective response of patients with ≥50% reduction of numbers of bleeding episodes, followed by rate of cases with cessation of bleedin, the difference in blood transfusion, hospitalization, transfusion volume of red cell, average bleeding duration, average hemoglobin level, yearly hospitalization times, average hospital stay and yearly bleeding episodes. This study will be done at 10 centers in China.
- Conditions
- Gastrointestinal Vascular Malformation
- Being tested
- Thalidomide (100mg), Thalidomide (50mg), placebo
- Keywords
- Gastrointestinal vascular malformation, thalidomide, Small intestinal bleeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thalidomide (100mg)Drug
Also called Group 1
Patients were randomly assigned to receive a 120-days course of 100 mg of thalidomide (Pharmaceutical Co., Ltd. of ChangZhou, China).
Thalidomide (50mg)Drug
Also called Group 2
Patients were randomly assigned to receive a 120-days course of 50 mg of thalidomide (Pharmaceutical Co., Ltd. of ChangZhou, China).
placeboDrug
Also called Group 3
Patients were randomly assigned to receive a 120-days course of placebo (Pharmaceutical Co., Ltd. of ChangZhou, China).
| Study group | Role | What they receive |
|---|---|---|
| Thalidomide Group（100mg） | Experimental | Generic name:Thalidomide Dosage form:tablet, 25mg Dosage:100mg/day Frequency: 25mg, QID, Oral Duration:120 days Receives: Drug: Thalidomide (100mg) |
| Thalidomide Group（50mg） | Experimental | Generic name:Thalidomide Dosage form:tablet, 25mg\&Placebo Dosage:50mg/day Frequency: 25mg BID \&Placebo, BID, Oral Duration:120 days Receives: Drug: Thalidomide (50mg) |
| placebo -controlled Group | Placebo comparator | Generic name:Thalidomide Placebo Dosage form:tablet, Placebo Dosage:Placebo Frequency: Placebo, QID, Oral Duration:120 days Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
effective response rate
the proportion of patients with "effective treatment, patients with ≥50% reduction of numbers of bleeding episodes after treatment during the First 1-year follow-up versus the 1-year Observation Period.
Measured: First 1-year follow-up versus the 1-year Observation Period.
Secondary outcomes (9)
overall rate of cases with cessation of bleeding
The overall rate of cases with cessation of bleeding without rebleeding during the First 1-year Follow-up Period.
Measured: First 1-year follow-up versus the 1-year Observation Period.
rate of cases requiring blood transfusion
The rate of cases requiring blood transfusion during the First 1-year follow-up.
Measured: First 1-year follow-up versus the 1-year Observation Period.
rate of cases requiring hospitalizations due to bleeding
The rate of cases requiring hospitalizations due to bleeding during the 1st 1-year follow-up
Measured: First 1-year follow-up versus the 1-year Observation Period.
change in the transfusion volume of red cell
The change in the transfusion volume of red cell during the First 1-year Follow-up Period versus the Observation Period.
Measured: First 1-year follow-up versus the 1-year Observation Period.
change in average bleeding duration
The change in average bleeding duration (days) during the First 1-year Follow-up Period versus the Observation Period.
Measured: First 1-year follow-up versus the 1-year Observation Period.
change in average hemoglobin level
The change in average hemoglobin level (g/L) during the First 1-year Follow-up Period versus the Observation Period.
Measured: First 1-year follow-up versus the 1-year Observation Period.
change in yearly hospitalization times
The change in yearly hospitalization times due to bleeding during the First 1-year Follow-up Period versus the Observation Period.
Measured: First 1-year follow-up versus the 1-year Observation Period.
change in average hospital stay
The change in average hospital stay (days)due to bleeding during the First 1-year Follow-up Period versus the Observation Period.
Measured: First 1-year follow-up versus the 1-year Observation Period.
change in yearly bleeding episodes
The change in yearly bleeding episodes during the First 1-year Follow-up Period versus the Observation Period.
Measured: First 1-year follow-up versus the 1-year Observation Period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2020
- Study completionApr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal Vascular MalformationStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Nanfang Hospital, 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
- Responsible party
- Principal investigator, Zhizheng Ge, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707484
- Sponsor's protocol ID
- rj(2015)088K-a
- Status last verified
- Jun 2023
- First submitted
- 17 Nov 2015
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ge ZZ, Chen HM, Gao YJ, Liu WZ, Xu CH, Tan HH, Chen HY, Wei W, Fang JY, Xiao SD. Efficacy of thalidomide for refractory gastrointestinal bleeding from vascular malformation. Gastroenterology. 2011 Nov;141(5):1629-37.e1-4. doi: 10.1053/j.gastro.2011.07.018. Epub 2011 Jul 22.
PubMed 21784047Ge ZZ, Chen HY, Gao YJ, Hu YB, Xiao SD. Best candidates for capsule endoscopy for obscure gastrointestinal bleeding. J Gastroenterol Hepatol. 2007 Dec;22(12):2076-80. doi: 10.1111/j.1440-1746.2006.04724.x.
PubMed 18031363Tan H, Chen H, Xu C, Ge Z, Gao Y, Fang J, Liu W, Xiao S. Role of vascular endothelial growth factor in angiodysplasia: an interventional study with thalidomide. J Gastroenterol Hepatol. 2012 Jun;27(6):1094-101. doi: 10.1111/j.1440-1746.2011.06967.x.
PubMed 22098296Li XB, Ge ZZ, Dai J, Gao YJ, Liu WZ, Hu YB, Xiao SD. The role of capsule endoscopy combined with double-balloon enteroscopy in diagnosis of small bowel diseases. Chin Med J (Engl). 2007 Jan 5;120(1):30-5.
PubMed 17254484Tan HH, Ge ZZ, Gao YJ, Chen HM, Fang JY, Chen HY, Liu WZ, Xiao SD. The role of HIF-1, angiopoietin-2, Dll4 and Notch1 in bleeding gastrointestinal vascular malformations and thalidomide-associated actions: a pilot in vivo study. J Dig Dis. 2011 Oct;12(5):349-56. doi: 10.1111/j.1751-2980.2011.00506.x.
PubMed 21955427Feng Q, Tan HH, Ge ZZ, Gao YJ, Chen HM, Xiao SD. Thalidomide-induced angiopoietin 2, Notch1 and Dll4 downregulation under hypoxic condition in tissues with gastrointestinal vascular malformation and human umbilical vein endothelial cells. J Dig Dis. 2014 Feb;15(2):85-95. doi: 10.1111/1751-2980.12114.
PubMed 24219762Chen H, Wu S, Tang M, Zhao R, Zhang Q, Dai Z, Gao Y, Yang S, Li Z, Du Y, Yang A, Zhong L, Lu L, Xu L, Shen X, Liu S, Zhong J, Li X, Lu H, Xiong H, Shen Y, Chen H, Gong S, Xue H, Ge Z. Thalidomide for Recurrent Bleeding Due to Small-Intestinal Angiodysplasia. N Engl J Med. 2023 Nov 2;389(18):1649-1659. doi: 10.1056/NEJMoa2303706.
PubMed 37913505
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study of Efficacy of Thalidomide for Refractory Small Intestinal Bleeding From Vascular Malformation
- ClinicalTrials.gov ID
- NCT02707484
- Acronym / sponsor ID
- rj(2015)088K-a
- Conditions
- Gastrointestinal Vascular Malformation
- Keywords
- Gastrointestinal vascular malformation, thalidomide, Small intestinal bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Nanfang Hospital, 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
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Apr 2021 (actual)
- First posted
- 14 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 effective response of patients with ≥50% reduction of numbers of bleeding episodes, followed by rate of cases with cessation of bleedin, the difference in blood transfusion, hospitalization, transfusion volume of red cell, average bleeding duration, average hemoglobin level, yearly hospitalization times, average hospital stay and yearly bleeding episodes. This study will be done at 10 centers in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Thalidomide Group（100mg） | Experimental | Drug: Thalidomide (100mg)Generic name:Thalidomide Dosage form:tablet, 25mg Dosage:100mg/day Frequency: 25mg, QID, Oral Duration:120 days |
| Thalidomide Group（50mg） | Experimental | Drug: Thalidomide (50mg)Generic name:Thalidomide Dosage form:tablet, 25mg\&Placebo Dosage:50mg/day Frequency: 25mg BID \&Placebo, BID, Oral Duration:120 days |
| placebo -controlled Group | Placebo comparator | Drug: placeboGeneric name:Thalidomide Placebo Dosage form:tablet, Placebo Dosage:Placebo Frequency: Placebo, QID, Oral Duration:120 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects voluntarily signed the informed consent after the nature and the specific procedures of the trial has been verbally explained; they have the opportunity to ask questions.
- Chinese nationality;
- Female or male subjects aged 18-75 years. Female subjects must be menopausal or have undergone sterilization such as tubal ligation and hysterectomy, or have no plan to give birth recently and agree to take contraceptive measures such as contraceptive drugs, intrauterine physical birth control rings or contraception condoms; or men must have undergone sterilization or do not plan to have a child recently and agree to take contraceptive measures such as contraceptive drugs, or contraception condoms. These criteria are set to eliminate the risk of subjects of child bearing potential.
- The subjects must have been diagnosed, by capsule endoscopy and / or balloon-assisted enteroscopy, with small intestinal vascular malformation lesions which are unsuitable or inaccessible to endoscopic therapy or surgical antrectomy. Subjects with persistent, recurrent bleeding, ≥ 4 episodes of overt or occult bleeding over last year.
Key exclusion criteria (11 listed)
- Subjects with esophageal varices from cirrhosis of the liver; those with uncontrolled hypertension or hyperglycemia (or diabetics who are being treated with insulin), or those with severe heart (e.g., uncontrolled angina pectoris and / or myocardial infarction, congestive heart failure, etc.), respiratory failure, or renal failure with creatinine (Cr) or blood urea nitrogen (BUN) > 2 times the upper limit of normal (ULN), pancreatic or hepatic disease with abnormal hepatic function with alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin (TBil) > 2 times ULN 3 months before the enrollment, or those with any other diseases that are not suitable for the study as judged by the Investigator;
- Subjects with a history of severe peripheral neuropathy or seizures, or a history of thromboembolic disease;
- Subjects who need to continuously use non-steroidal anti-inflammatory drugs, anticoagulants, antiplatelets, acetylsalicylic acid preparations, or Chinese herbal medicines containing ginkgo and echinacea; or those who need to receive other anti-angiogenic drugs for a long time;
- Subjects with white blood cell counts persistently <3.5 * 10^9 / L;
- Subjects with a history of small bowel resection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thalidomide (100mg)Also: Group 1Patients were randomly assigned to receive a 120-days course of 100 mg of thalidomide (Pharmaceutical Co., Ltd. of ChangZhou, China). | Drug | Thalidomide Group（100mg） |
| Thalidomide (50mg)Also: Group 2Patients were randomly assigned to receive a 120-days course of 50 mg of thalidomide (Pharmaceutical Co., Ltd. of ChangZhou, China). | Drug | Thalidomide Group（50mg） |
| placeboAlso: Group 3Patients were randomly assigned to receive a 120-days course of placebo (Pharmaceutical Co., Ltd. of ChangZhou, China). | Drug | placebo -controlled Group |
Primary outcome
effective response rate
Time frame: First 1-year follow-up versus the 1-year Observation Period.
the proportion of patients with "effective treatment, patients with ≥50% reduction of numbers of bleeding episodes after treatment during the First 1-year follow-up versus the 1-year Observation Period.
9 secondary outcomes
overall rate of cases with cessation of bleeding
Time frame: First 1-year follow-up versus the 1-year Observation Period.
rate of cases requiring blood transfusion
Time frame: First 1-year follow-up versus the 1-year Observation Period.
rate of cases requiring hospitalizations due to bleeding
Time frame: First 1-year follow-up versus the 1-year Observation Period.
change in the transfusion volume of red cell
Time frame: First 1-year follow-up versus the 1-year Observation Period.
change in average bleeding duration
Time frame: First 1-year follow-up versus the 1-year Observation Period.
change in average hemoglobin level
Time frame: First 1-year follow-up versus the 1-year Observation Period.
change in yearly hospitalization times
Time frame: First 1-year follow-up versus the 1-year Observation Period.
change in average hospital stay
Time frame: First 1-year follow-up versus the 1-year Observation Period.
change in yearly bleeding episodes
Time frame: First 1-year follow-up versus the 1-year Observation Period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Results publication: PubMed 21784047Ge ZZ, Chen HM, Gao YJ, Liu WZ, Xu CH, Tan HH, Chen HY, Wei W, Fang JY, Xiao SD. Efficacy of thalidomide for refractory gastrointestinal bleeding from vascular malformation. Gastroenterology. 2011 Nov;141(5):1629-37.e1-4. doi: 10.1053/j.gastro.2011.07.018. Epub 2011 Jul 22.
- Results publication: PubMed 18031363Ge ZZ, Chen HY, Gao YJ, Hu YB, Xiao SD. Best candidates for capsule endoscopy for obscure gastrointestinal bleeding. J Gastroenterol Hepatol. 2007 Dec;22(12):2076-80. doi: 10.1111/j.1440-1746.2006.04724.x.
- Results publication: PubMed 22098296Tan H, Chen H, Xu C, Ge Z, Gao Y, Fang J, Liu W, Xiao S. Role of vascular endothelial growth factor in angiodysplasia: an interventional study with thalidomide. J Gastroenterol Hepatol. 2012 Jun;27(6):1094-101. doi: 10.1111/j.1440-1746.2011.06967.x.
- Results publication: PubMed 17254484Li XB, Ge ZZ, Dai J, Gao YJ, Liu WZ, Hu YB, Xiao SD. The role of capsule endoscopy combined with double-balloon enteroscopy in diagnosis of small bowel diseases. Chin Med J (Engl). 2007 Jan 5;120(1):30-5.
- Results publication: PubMed 21955427Tan HH, Ge ZZ, Gao YJ, Chen HM, Fang JY, Chen HY, Liu WZ, Xiao SD. The role of HIF-1, angiopoietin-2, Dll4 and Notch1 in bleeding gastrointestinal vascular malformations and thalidomide-associated actions: a pilot in vivo study. J Dig Dis. 2011 Oct;12(5):349-56. doi: 10.1111/j.1751-2980.2011.00506.x.
- Results publication: PubMed 24219762Feng Q, Tan HH, Ge ZZ, Gao YJ, Chen HM, Xiao SD. Thalidomide-induced angiopoietin 2, Notch1 and Dll4 downregulation under hypoxic condition in tissues with gastrointestinal vascular malformation and human umbilical vein endothelial cells. J Dig Dis. 2014 Feb;15(2):85-95. doi: 10.1111/1751-2980.12114.
- Derived from this study: PubMed 37913505Chen H, Wu S, Tang M, Zhao R, Zhang Q, Dai Z, Gao Y, Yang S, Li Z, Du Y, Yang A, Zhong L, Lu L, Xu L, Shen X, Liu S, Zhong J, Li X, Lu H, Xiong H, Shen Y, Chen H, Gong S, Xue H, Ge Z. Thalidomide for Recurrent Bleeding Due to Small-Intestinal Angiodysplasia. N Engl J Med. 2023 Nov 2;389(18):1649-1659. doi: 10.1056/NEJMoa2303706.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thalidomide (100mg) and Thalidomide (50mg) in people with Gastrointestinal Vascular Malformation, run by Shanghai Jiao Tong University School of Medicine at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effective response rate (time frame: First 1-year follow-up versus the 1-year Observation Period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02707484, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023; AzTrials last refreshed its copy on 1 Nov 2026.