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Retreatment and Its Efficiency of Thalidomide for Vascular Malformation Patients With Failure of First Course Treatment

NCT02301949 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2016-04-21

No results posted yet for this study

Summary

Background: Repeated episodes of bleeding from gastrointestinal vascular malformations refractory to endoscopic or surgical therapy often pose a major therapeutic challenge.

Methods: The investigators will perform a randomized, double blind, placebo controlled study of thalidomide as a retreatment therapy for recurrent gastrointestinal bleeding due to vascular malformation. Patients with failure of first course treatment of thalidomide will be randomly grouped, prescribed a second four-month course regimen of 25 mg of thalidomide or placebo orally four times daily. All patients will be monitored for at least one year. The primary end point is defined as the patients whose rebleeds decrease from baseline by ≥ 50% at 12 months and the cessation of bleeding. Rebleeding is defined based on a positive fecal occult blood test (FOBT) (monoclonal colloidal gold color technology) at any visit after treatment. Secondary outcomes include the participants dependent on blood transfusions and changes from baseline in transfused packed red cell units, bleeding episodes, and hemoglobin levels at 12 months. Statistical significance is defined at P \< 0.05.

Conditions

  • Gastrointestinal Bleeding of Unknown Origin
  • Gastrointestinal Vascular Malformation
  • Thalidomide Efficiency

Interventions

DRUG

Thalidomide

Patients are randomly assigned to receive a second course of four-month treatment of thalidomide (Pharmaceutical Co., Ltd. of ChangZhou, China). Medications are taken orally 25mg four times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m.

OTHER

Placebo

Patients are randomly assigned to receive placebo tablets (Pharmaceutical Co., Ltd. of ChangZhou, China) four times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m.

Sponsors & Collaborators

  • Zhizheng Ge

    lead OTHER

Principal Investigators

  • Zhizheng Ge, MD. Ph.D · Shanghai Ren Ji Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2015-12-31
Completion
2018-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02301949 on ClinicalTrials.gov