Gastrointestinal HemorrhagePhase 2NCT02754960
Efficacy Study of Thalidomide in Gastrointestinal Vascular Malformation Related Bleeding
A Phase 2 study testing Thalidomide in people with Gastrointestinal Hemorrhage and Vascular Malformation, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Background: Repeated bleeding from gastrointestinal vascular malformations remains to be a major therapeutic challenge. Methods: The investigators performed a randomised, double-blind, placebo-controlled, single centre study to assess the long-term efficacy and safety of thalidomide 100mg qn p.o. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Hemorrhage, Vascular Malformation
- What is being tested?
- Thalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Mar 2010to Sep 2014
- Phase
- Phase 2
- 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 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 40-85 years; women were post-menopausal, post-tubal ligation, or on some form of birth control like long-term laying up contraceptive ring or using condom;
- History of at least six documented gastrointestinal bleeding episodes in the year prior to randomization, which were refractory or inaccessible to endoscopic therapy or surgical ectomy;
- Confirmed diagnosis of vascular malformation by esophagogastroduodenoscopy (EGD), capsule endoscope (CE), double-balloon endoscope (DBE), or colonoscopy, but no obvious infectious, neoplastic, or other specific diagnosis;
- Angiodysplasia at endoscopy characterized by focal or diffused venous/capillary lesions presenting as bright red ectatic vessels or pulsatile red protrusions, with surrounding venous dilatation or patchy erythema with or without oozing;
Who cannot join
- Less than 1 year of bleeding history;
- GI bleeding caused by Esophageal varices, Mallory Weiss syndrome, Zollinger-Ellison syndrome, Suspicion of gastric malignancy at baseline endoscopy, Post-Billroth-resection, Biliary disorders, Gastrointestinal tumors, Crohn's disease or Ulcerative colitis, Hemangioma or unknown source of GI bleeding;
- Bleeding that needs emergent endoscopic treatment or surgery;
- Any significant "alarm symptoms" within the past 6 months, such as, unintentional weight loss, signs of gastrointestinal bleeding more than 2 weeks prior to enrolment, jaundice, or any other sign indicating serious or malignant disease;
- Malignancy or clinically significant cardiovascular, pulmonary, renal, pancreatic, hepatic disease, cirrhotic or portal hypertension gastropathy, rheumatologic disorders, uncontrollable diabetes mellitus or hypertension as judged by the investigator;
- A history of severe bilateral peripheral neuropathy or seizure activity, thromboembolic disease;
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- A history of treatment with any dose of systemic or oral topical corticosteroids or aspirin, NSAIDs, anti-platelet drugs, anticoagulants, or Chinese medications (with salicylates), gingko, or Echinacea, or other putative immunomodulators or anti-angiogenic agents;
- Haemorrhagic disorders, platelets<100 x 109/ L, APTT>1.5x upper limit of normal (ULN), or treatment with low-molecular weight heparin;
- Need for continuous concurrent therapy during the study period with NSAIDs, ASA (including low dose),Warfarin (including other Vit K antagonists), anti-platelet drugs, anticoagulants, mephenytoin, atazanavir or Chinese medications (with salicylates), gingko, or Echinacea, or other putative immunomodulators or anti-angiogenic agents;
- Pregnancy or lactation. Woman of child-bearing potential must be either non-pregnant or postmenopausal or must use a reliable form of contraception during the study period, as judged by the investigator;
- Allergy to study medications;
- Currently undergoing systemic cancer chemotherapy or receiving radiation or had underwent systemic cancer chemotherapy or received radiation treatment.
- Use of any other investigational compound or participation in another clinical trial within 30 days prior to start of study medication;
- Alcohol and/or drug abuse (addiction or drug dependence) or any condition associated with poor compliance, including expected non-cooperation, as judged by the investigator;
- Previous participation in the study;
- Involvement in the planning and conduct of the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Gastroenterology department; Ren Ji Hospital
Shanghai, Shanghai Municipality, 200127
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Study of Thalidomide in Gastrointestinal Vascular Malformation Related Bleeding
Background: Repeated bleeding from gastrointestinal vascular malformations remains to be a major therapeutic challenge.
Methods: The investigators performed a randomised, double-blind, placebo-controlled, single centre study to assess the long-term efficacy and safety of thalidomide 100mg qn p.o. or placebo 100 mg qn p.o. administration for 4 months in subjects with recurrent gastrointestinal bleeding due to vascular malformations. Patients with at least six episodes of bleeding in the prior year due to vascular malformation were randomly grouped, prescribed a four-month regimen of either 100mg of thalidomide or 100 mg of placebo orally one time daily, and monitored for at least one year. The primary end point was defined as the patients whose rebleeds decreased from baseline by ≥ 50% at 12 months. Rebleeding was defined based on a positive fecal occult blood test (FOBT) (monoclonal colloidal gold color technology) at any visit after treatment. Secondary outcomes included the changes from baseline in participants dependent on blood transfusions and transfused packed red cell units, bleeding episodes, bleeding durations, and hemoglobin levels at 12 months. Statistical significance was defined at P < 0.05.
Read the detailed description
Study design:
The study will be carried out as a single-centre, randomized, double-blind, parallel-group, placebo-controlled phase II study in subjects with recurrent gastrointestinal bleeding due to vascular malformations.
Subjects Enrollment and Assignment:
Approximately 100 patients aged between 40-85 years with recurrent gastrointestinal bleeding (melena and/or fresh hematemesis or positive FOBT) at least 6 times within one year, verified as vascular malformation by capsule endoscopies or enteroscopies at baseline.
Randomization was performed through the proc plan procedure of SAS, using the method of randomly permuted blocks of 4. Within each block, the number of patients allocated to each of the two treatments was equal. Subjects who are eligible for randomisation will be given a subject number in consecutive order within blocks, and the investigational products packed corresponding to this number. The subject will be allocated to one of the two treatment groups, i.e. Thalidomide and placebo, according to a computer generated list provided by Pharmaceutical Co., Ltd. of Chang Zhou, China. If a subject discontinues from the study, the subject number will not be reused, and the subject will not be allowed to re-enter the study.
Intervention:
The included patients were prospectively randomized into two groups: the thalidomide group and the placebo group (Thalidomide group: Thalidomide p.o. 100 mg for 4 months, qn; Placebo group: Placebo for thalidomide p.o. 100 mg for 4 months, qn).
The following concomitant medications are not allowed during the study as they interfere with the disease under study: Anti-angiogenic agents or other putative immunomodulators, Anti-platelet drugs, anticoagulants, or Chinese medications (with salicylates), gingko, or Echinacea, Somatostatin Heparin, Warfarin (including other Vit K antagonists), NSAIDs(including low dose); or as there is a potential risk for drug-drug interactions: Paxil (paroxetine), Mysoline (primidone), Keppra (levetiracetam), Plaquenil (hydroxychloroquine), St John's Wort (st. john's wort), Tegretol (carbamazepine), Zometa (zoledronic acid).
Assessment of response and adverse events:
The primary end point was defined as the patients whose rebleeds decreased from baseline by ≥ 50% at 12 months. Rebleeding was defined based on a positive fecal occult blood test (FOBT) (monoclonal colloidal gold color technology) at any visit after treatment. The secondary outcomes included the changes from baseline in participants dependent on blood transfusions and transfused packed red cell units, bleeding episodes, bleeding durations, and hemoglobin levels at 12 months.
An adverse event (AE) is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
A serious adverse event is an AE occurring during any study phase (ie, run-in, treatment, follow-up), and at any dose of the investigational product, comparator or placebo, that fulfils one or more of the following criteria:
Results in death; Deep vein thrombosis (DVT); Is immediately life-threatening; Requires prolongation of existing hospitalisation; Results in persistent or significant disability or incapacity; Is a congenital abnormality or birth defect; Is an important medical event that may jeopardise the subject or may require medical intervention to prevent one of the outcomes listed above.
Evaluation of Patients and Follow-up:
- Certified research nurses collected information on the demographics and medical and social histories of all patients enrolled in the study.
- After screening and baseline evaluations, the patients were closely monitored in the hospital for at least one week. They were then followed twice monthly during the four-mouth course of treatment and once a month thereafter.
- Clinical follow-up was performed by qualified doctors. At all visits, the bleeding-related parameters (number and duration), a physical examination was performed and laboratory values were obtained for FOBT, complete blood counts, serum chemistries, and hepatic and renal function. Neuropathy and other adverse events were also assessed.
- Patients were advised to refrain from any other non-prescribed medicines, especially rebleeding-related medications such as aspirin, NSAIDs, anti-platelet drugs, anticoagulants, and Chinese medications (with salicylates), gingko, or Echinacea.
- Conditions
- Gastrointestinal Hemorrhage, Vascular Malformation
- Being tested
- Thalidomide, Placebo
- Keywords
- Gastrointestinal bleeding, Vascular malformation, Angiodysplasia, Thalidomide
- Medical subject headings
- Gastrointestinal Hemorrhage, Vascular Malformations, Angiodysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
Also called Softenon
Interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 1 time daily at 10 p.m)
PlaceboDrug
Also called Thalidomide placebo
Placebo administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 1 time daily at 10 p.m)
| Study group | Role | What they receive |
|---|---|---|
| Thalidomide group | Active comparator | Patients were randomly assigned to the thalidomide group and received 100 mg of thalidomide (Pharmaceutical Co., Ltd. of Chang Zhou, China) orally four times daily at 10 p.m. for four months. Receives: Drug: Thalidomide |
| Placebo group | Placebo comparator | Patients were randomly assigned to the placebo group and received 100 mg of thalidomide placebo (Pharmaceutical Co., Ltd. of Chang Zhou, China) orally four times daily at 10 p.m. for four months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects whose bleeding episode decreased from baseline by ≥ 50% at 12 months follow-up after 4-month treatment
Proportion of subjects whose bleeding episode decreased from baseline by ≥ 50% at 12 months follow-up after 4-month treatment. The details are showed as follows: Reduction of bleeding episode = [(total bleeding episodes at 12 months - total bleeding episodes at a year before randomisation)/total bleeding episodes at a year before randomisation (baseline)]*100%. Rebleeding was defined based on a positive fecal occult blood test (FOBT) (monoclonal colloidal gold color technology) at any visit after treatment.
Measured: 12 months
Secondary outcomes (5)
Change from baseline in bleeding episodes at 12 months
Change from baseline in bleeding episodes at 12 months
Measured: baseline and 12 months
Change from baseline in bleeding duration at 12 months
Change from baseline in bleeding duration at 12 months
Measured: baseline and 12 months
Change from baseline in proportion of subjects who dependent on blood transfusions at 12 months
Change from baseline in proportion of subjects who dependent on blood transfusions at 12 months
Measured: baseline and 12 months
Change from baseline in number of blood units transfused in subjects who dependent on blood transfusions at 12 months
Change from baseline in number of blood units transfused in subjects who dependent on blood transfusions at 12 months
Measured: baseline and 12 months
Change from baseline in average hemoglobin (Hb) level at 12 months
Change from baseline in average hemoglobin (Hb) level at 12 months
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startMar 2010
- Primary completionMar 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal HemorrhageStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhizheng Ge, Shanghai Jiao Tong University School of Medicine
- Investigators
- Zhizheng Ge, Ph.D, MD., Principal investigator, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754960
- Sponsor's protocol ID
- rjyyxhk57809
- Status last verified
- Apr 2016
- First submitted
- 26 Apr 2016
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jacobson JM, Greenspan JS, Spritzler J, Ketter N, Fahey JL, Jackson JB, Fox L, Chernoff M, Wu AW, MacPhail LA, Vasquez GJ, Wohl DA. Thalidomide for the treatment of oral aphthous ulcers in patients with human immunodeficiency virus infection. National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group. N Engl J Med. 1997 May 22;336(21):1487-93. doi: 10.1056/NEJM199705223362103.
PubMed 9154767Bauditz J, Schachschal G, Wedel S, Lochs H. Thalidomide for treatment of severe intestinal bleeding. Gut. 2004 Apr;53(4):609-12. doi: 10.1136/gut.2003.029710.
PubMed 15016759
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Study of Thalidomide in Gastrointestinal Vascular Malformation Related Bleeding
- ClinicalTrials.gov ID
- NCT02754960
- Acronym / sponsor ID
- rjyyxhk57809
- Conditions
- Gastrointestinal Hemorrhage, Vascular Malformation
- Keywords
- Gastrointestinal bleeding, Vascular malformation, Angiodysplasia, Thalidomide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 28 Apr 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.
Background: Repeated bleeding from gastrointestinal vascular malformations remains to be a major therapeutic challenge.
Methods: The investigators performed a randomised, double-blind, placebo-controlled, single centre study to assess the long-term efficacy and safety of thalidomide 100mg qn p.o. or placebo 100 mg qn p.o. administration for 4 months in subjects with recurrent gastrointestinal bleeding due to vascular malformations. Patients with at least six episodes of bleeding in the prior year due to vascular malformation were randomly grouped, prescribed a four-month regimen of either 100mg of thalidomide or 100 mg of placebo orally one time daily, and monitored for at least one year. The primary end point was defined as the patients whose rebleeds decreased from baseline by ≥ 50% at 12 months. Rebleeding was defined based on a positive fecal occult blood test (FOBT) (monoclonal colloidal gold color technology) at any visit after treatment. Secondary outcomes included the changes from baseline in participants dependent on blood transfusions and transfused packed red cell units, bleeding episodes, bleeding durations, and hemoglobin levels at 12 months. Statistical significance was defined at P < 0.05.
Detailed description
Study design:
The study will be carried out as a single-centre, randomized, double-blind, parallel-group, placebo-controlled phase II study in subjects with recurrent gastrointestinal bleeding due to vascular malformations.
Subjects Enrollment and Assignment:
Approximately 100 patients aged between 40-85 years with recurrent gastrointestinal bleeding (melena and/or fresh hematemesis or positive FOBT) at least 6 times within one year, verified as vascular malformation by capsule endoscopies or enteroscopies at baseline.
Randomization was performed through the proc plan procedure of SAS, using the method of randomly permuted blocks of 4. Within each block, the number of patients allocated to each of the two treatments was equal. Subjects who are eligible for randomisation will be given a subject number in consecutive order within blocks, and the investigational products packed corresponding to this number. The subject will be allocated to one of the two treatment groups, i.e. Thalidomide and placebo, according to a computer generated list provided by Pharmaceutical Co., Ltd. of Chang Zhou, China. If a subject discontinues from the study, the subject number will not be reused, and the subject will not be allowed to re-enter the study.
Intervention:
The included patients were prospectively randomized into two groups: the thalidomide group and the placebo group (Thalidomide group: Thalidomide p.o. 100 mg for 4 months, qn; Placebo group: Placebo for thalidomide p.o. 100 mg for 4 months, qn).
The following concomitant medications are not allowed during the study as they interfere with the disease under study: Anti-angiogenic agents or other putative immunomodulators, Anti-platelet drugs, anticoagulants, or Chinese medications (with salicylates), gingko, or Echinacea, Somatostatin Heparin, Warfarin (including other Vit K antagonists), NSAIDs(including low dose); or as there is a potential risk for drug-drug interactions: Paxil (paroxetine), Mysoline (primidone), Keppra (levetiracetam), Plaquenil (hydroxychloroquine), St John's Wort (st. john's wort), Tegretol (carbamazepine), Zometa (zoledronic acid).
Assessment of response and adverse events:
The primary end point was defined as the patients whose rebleeds decreased from baseline by ≥ 50% at 12 months. Rebleeding was defined based on a positive fecal occult blood test (FOBT) (monoclonal colloidal gold color technology) at any visit after treatment. The secondary outcomes included the changes from baseline in participants dependent on blood transfusions and transfused packed red cell units, bleeding episodes, bleeding durations, and hemoglobin levels at 12 months.
An adverse event (AE) is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
A serious adverse event is an AE occurring during any study phase (ie, run-in, treatment, follow-up), and at any dose of the investigational product, comparator or placebo, that fulfils one or more of the following criteria:
Results in death; Deep vein thrombosis (DVT); Is immediately life-threatening; Requires prolongation of existing hospitalisation; Results in persistent or significant disability or incapacity; Is a congenital abnormality or birth defect; Is an important medical event that may jeopardise the subject or may require medical intervention to prevent one of the outcomes listed above.
Evaluation of Patients and Follow-up:
- Certified research nurses collected information on the demographics and medical and social histories of all patients enrolled in the study.
- After screening and baseline evaluations, the patients were closely monitored in the hospital for at least one week. They were then followed twice monthly during the four-mouth course of treatment and once a month thereafter.
- Clinical follow-up was performed by qualified doctors. At all visits, the bleeding-related parameters (number and duration), a physical examination was performed and laboratory values were obtained for FOBT, complete blood counts, serum chemistries, and hepatic and renal function. Neuropathy and other adverse events were also assessed.
- Patients were advised to refrain from any other non-prescribed medicines, especially rebleeding-related medications such as aspirin, NSAIDs, anti-platelet drugs, anticoagulants, and Chinese medications (with salicylates), gingko, or Echinacea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thalidomide group | Active comparator | Drug: ThalidomidePatients were randomly assigned to the thalidomide group and received 100 mg of thalidomide (Pharmaceutical Co., Ltd. of Chang Zhou, China) orally four times daily at 10 p.m. for four months. |
| Placebo group | Placebo comparator | Drug: PlaceboPatients were randomly assigned to the placebo group and received 100 mg of thalidomide placebo (Pharmaceutical Co., Ltd. of Chang Zhou, China) orally four times daily at 10 p.m. for four months. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 40-85 years; women were post-menopausal, post-tubal ligation, or on some form of birth control like long-term laying up contraceptive ring or using condom;
- History of at least six documented gastrointestinal bleeding episodes in the year prior to randomization, which were refractory or inaccessible to endoscopic therapy or surgical ectomy;
- Confirmed diagnosis of vascular malformation by esophagogastroduodenoscopy (EGD), capsule endoscope (CE), double-balloon endoscope (DBE), or colonoscopy, but no obvious infectious, neoplastic, or other specific diagnosis;
- Angiodysplasia at endoscopy characterized by focal or diffused venous/capillary lesions presenting as bright red ectatic vessels or pulsatile red protrusions, with surrounding venous dilatation or patchy erythema with or without oozing;
Key exclusion criteria (16 listed)
- Less than 1 year of bleeding history;
- GI bleeding caused by Esophageal varices, Mallory Weiss syndrome, Zollinger-Ellison syndrome, Suspicion of gastric malignancy at baseline endoscopy, Post-Billroth-resection, Biliary disorders, Gastrointestinal tumors, Crohn's disease or Ulcerative colitis, Hemangioma or unknown source of GI bleeding;
- Bleeding that needs emergent endoscopic treatment or surgery;
- Any significant "alarm symptoms" within the past 6 months, such as, unintentional weight loss, signs of gastrointestinal bleeding more than 2 weeks prior to enrolment, jaundice, or any other sign indicating serious or malignant disease;
- Malignancy or clinically significant cardiovascular, pulmonary, renal, pancreatic, hepatic disease, cirrhotic or portal hypertension gastropathy, rheumatologic disorders, uncontrollable diabetes mellitus or hypertension as judged by the investigator;
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 |
|---|---|---|
| ThalidomideAlso: SoftenonInterventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 1 time daily at 10 p.m) | Drug | Thalidomide group |
| PlaceboAlso: Thalidomide placeboPlacebo administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 1 time daily at 10 p.m) | Drug | Placebo group |
Primary outcome
Proportion of subjects whose bleeding episode decreased from baseline by ≥ 50% at 12 months follow-up after 4-month treatment
Time frame: 12 months
Proportion of subjects whose bleeding episode decreased from baseline by ≥ 50% at 12 months follow-up after 4-month treatment. The details are showed as follows: Reduction of bleeding episode = [(total bleeding episodes at 12 months - total bleeding episodes at a year before randomisation)/total bleeding episodes at a year before randomisation (baseline)]*100%. Rebleeding was defined based on a positive fecal occult blood test (FOBT) (monoclonal colloidal gold color technology) at any visit after treatment.
5 secondary outcomes
Change from baseline in bleeding episodes at 12 months
Time frame: baseline and 12 months
Change from baseline in bleeding duration at 12 months
Time frame: baseline and 12 months
Change from baseline in proportion of subjects who dependent on blood transfusions at 12 months
Time frame: baseline and 12 months
Change from baseline in number of blood units transfused in subjects who dependent on blood transfusions at 12 months
Time frame: baseline and 12 months
Change from baseline in average hemoglobin (Hb) level at 12 months
Time frame: baseline and 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
- Background: PubMed 9154767Jacobson JM, Greenspan JS, Spritzler J, Ketter N, Fahey JL, Jackson JB, Fox L, Chernoff M, Wu AW, MacPhail LA, Vasquez GJ, Wohl DA. Thalidomide for the treatment of oral aphthous ulcers in patients with human immunodeficiency virus infection. National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group. N Engl J Med. 1997 May 22;336(21):1487-93. doi: 10.1056/NEJM199705223362103.
- Background: PubMed 15016759Bauditz J, Schachschal G, Wedel S, Lochs H. Thalidomide for treatment of severe intestinal bleeding. Gut. 2004 Apr;53(4):609-12. doi: 10.1136/gut.2003.029710.
- Approved drug page at FDA's Drugs@FDA web siteLink provided by the sponsor.
- Protocol of previous open-label, randomised, iron-controlled study of long-term effects of thalidomide for recurrent gastrointestinal bleeding due to vascular malformationLink provided by the sponsor.
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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.
Zhizheng Ge, Ph.D, MD. principal investigator
Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thalidomide in people with Gastrointestinal Hemorrhage and Vascular Malformation, run by Shanghai Jiao Tong University School of Medicine at 1 site 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 16 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: withdrawn, as of the sponsor's last update on 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Proportion of subjects whose bleeding episode decreased from baseline by ≥ 50% at 12 months follow-up after 4-month treatment (time frame: 12 months). 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 NCT02754960, which also lists 2 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 28 Apr 2016.