A Phase 3 interventional study of Thalidomide (100mg) and Thalidomide (50mg) in Gastrointestinal Vascular Malformation, sponsored by Shanghai Jiao Tong University School of Medicine. Completed at 10 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-06-23.
Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 3, Interventional, and Treatment
Among 10 studies in Vascular Malformations with a site in China — 2 open to participants now, 3 under way, none of them phase 3. Vascular Malformations · China.
Among the 10 studies in Vascular Malformations with a site in China, this one is the 3rd largest by enrollment, is one of 2 that started in 2016, is one of 2 in phase 3, and was the 2nd registered.
79 studies on the registry are indexed under Vascular Malformations; 33 are open to participants now.
This study's enrollment of 150 is above the median of 55 across 49 interventional studies indexed under Vascular Malformations.
Browse Vascular Malformations studies →2 of the 10 studies in Vascular Malformations with a site in China are open now, in 2 countries. Each count lists the studies.
Of the 22 Vascular Malformations studies recruiting now, 13 (59%) set no upper age limit and 7 (32%) stop at 75 or younger; 15 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 2 started in 2016.
Median enrollment 78 across the 10 interventional studies. Of the 3 that completed or were terminated, 0 (0%) have results posted.
2 of 10 have an industry lead sponsor. The 7 most frequent:
Shanghai Jiao Tong University School of Medicine is the lead sponsor of 374 studies on the registry; 110 are open to participants now.
Shanghai Jiao Tong University School of Medicine has 4 studies filed under Vascular Malformations — fewer than ten, so there is no comparison to draw.
1 of the studies in Vascular Malformations with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07072403West China HospitalTrametinib Treatment for Complicated Vascular Anomalies | 2027-07-01 |
Among the 10 studies in Vascular Malformations with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Generic name:Thalidomide Dosage form:tablet, 25mg Dosage:100mg/day Frequency: 25mg, QID, Oral Duration:120 days
Drug: Thalidomide (100mg)
Generic name:Thalidomide Dosage form:tablet, 25mg\&Placebo Dosage:50mg/day Frequency: 25mg BID \&Placebo, BID, Oral Duration:120 days
Drug: Thalidomide (50mg)
Generic name:Thalidomide Placebo Dosage form:tablet, Placebo Dosage:Placebo Frequency: Placebo, QID, Oral Duration:120 days
Drug: placebo
Patients were randomly assigned to receive a 120-days course of 100 mg of thalidomide (Pharmaceutical Co., Ltd. of ChangZhou, China).
Also known as: Group 1
Patients were randomly assigned to receive a 120-days course of 50 mg of thalidomide (Pharmaceutical Co., Ltd. of ChangZhou, China).
Also known as: Group 2
Patients were randomly assigned to receive a 120-days course of placebo (Pharmaceutical Co., Ltd. of ChangZhou, China).
Also known as: Group 3
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.
Time frame: First 1-year follow-up versus the 1-year Observation Period.
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: First 1-year follow-up versus the 1-year Observation Period.
Ran from Apr 2016 to primary completion in Dec 2020, 56 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Thalidomide
Shanghai Jiao Tong University School of Medicine →