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Trial record 19 of 398 for:    bleeding episodes

Efficacy Study of Thalidomide in Gastrointestinal Vascular Malformation Related Bleeding

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ClinicalTrials.gov Identifier: NCT02754960
Recruitment Status : Withdrawn
First Posted : April 28, 2016
Last Update Posted : April 28, 2016
Sponsor:
Information provided by (Responsible Party):
Zhizheng Ge, Shanghai Jiao Tong University School of Medicine

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Gastrointestinal Hemorrhage Vascular Malformation Drug: Thalidomide Drug: Placebo Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled Study of Thalidomide in Gastrointestinal Vascular Malformation Related Bleeding
Study Start Date : March 2010
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : September 2014


Arm Intervention/treatment
Active Comparator: Thalidomide group
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.
Drug: Thalidomide
Interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 1 time daily at 10 p.m)
Other Name: Softenon

Placebo Comparator: Placebo group
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.
Drug: Placebo
Placebo administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 1 time daily at 10 p.m)
Other Name: Thalidomide placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change from baseline in bleeding episodes at 12 months [ Time Frame: baseline and 12 months ]
    Change from baseline in bleeding episodes at 12 months

  2. Change from baseline in bleeding duration at 12 months [ Time Frame: baseline and 12 months ]
    Change from baseline in bleeding duration at 12 months

  3. 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 proportion of subjects who dependent on blood transfusions at 12 months

  4. 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 number of blood units transfused in subjects who dependent on blood transfusions at 12 months

  5. Change from baseline in average hemoglobin (Hb) level at 12 months [ Time Frame: baseline and 12 months ]
    Change from baseline in average hemoglobin (Hb) level at 12 months



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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;
  • 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.

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): NCT02754960


Locations
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China, Shanghai
Gastroenterology department; Ren Ji Hospital
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Zhizheng Ge, Ph.D, MD. Ren Ji Hospital, Shanghai Jiao Tong university school of medicine

Additional Information:
Publications:
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Responsible Party: Zhizheng Ge, the director of the endoscopy center, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02754960     History of Changes
Other Study ID Numbers: rjyyxhk57809
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: April 2016

Keywords provided by Zhizheng Ge, Shanghai Jiao Tong University School of Medicine:
Gastrointestinal bleeding
Vascular malformation
Angiodysplasia
Thalidomide

Additional relevant MeSH terms:
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Hemorrhage
Gastrointestinal Hemorrhage
Congenital Abnormalities
Vascular Malformations
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Cardiovascular Abnormalities
Cardiovascular 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