Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.

• ClinicalTrials.gov Identifier: NCT01579110
• Recruitment Status: Unknown
• First Posted: April 17, 2012
• Last Update Posted: April 19, 2012
• Sponsor: Institute of Hematology & Blood Diseases Hospital
• Information provided by (Responsible Party): Yizhou Zheng, Institute of Hematology & Blood Diseases Hospital

Tracking Information

• First Submitted Date: April 13, 2012
• First Posted Date: April 17, 2012
• Last Update Posted Date: April 19, 2012
• Study Start Date: April 2012
• Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 14, 2012): Number of patients in each group in complete or partial remission [ Time Frame: one year ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: April 18, 2012): Side effects [ Time Frame: 1year ]
• Original Secondary Outcome Measures (submitted: April 14, 2012): sustained response, cumulative doses of prednisone and side effects [ Time Frame: 1year ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.
• Official Title: Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.
• Brief Summary: The purpose of this study is to determine whether Levamisole plus prednisone can further improve the efficacy，extend the remission duration and reduce the dosage of prednisone for newly diagnosed warm antibody autoimmune hemolytic anemia.
• Detailed Description: The first line treatment in warm antibody autoimmune hemolytic anemia (WAIHA) is the glucocorticoid, but most of the patients, hemolytic events will frequently recurred after end of treatment or during the gradual reduction in dosage of prednisolone. As a result, many patients will finally accepted long-term glucocorticoids or other immunosuppressive drugs. How to reduce the relapse rate of AIHA is still difficult. Levamisole（LMS）is a immunoregulator.Recent studies have shown LMS has been widely used to treat autoimmune diseases ,such as rheumatoid arthritis, systemic lupus erythematosus and idiopathic thrombocytopenic purpura. The purpose of this study is to determine whether LMS combined with prednisolone can further improve the efficacy，extend the remission duration and reduce the dosage of prednisone for newly diagnosed warm antibody autoimmune hemolytic anemia.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Anemia
• Anemia, Hemolytic
• Anemia, Hemolytic, Autoimmune
• Hemolysis
• Hematologic Diseases
• Autoimmune Diseases
• Immune System Diseases
• Pathologic Processes

Intervention

• Drug: levamisole

  Levamisole 2.5mg/kg(every other day) over six months.

  Prednisone 1mg/kg for two weeks and then tapered off dosage over two months.

• Drug: Prednisone
  Prednisone 1mg/kg for two weeks and then tapered off dosage over two months.

Study Arms

• Experimental: prednisolone + levamisole
  Intervention: Drug: levamisole
• Active Comparator: Prednisone
  Intervention: Drug: Prednisone

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 14, 2012): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2016
• Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Clinical and biochemical signs of hemolytic anaemia
• Positive Coombs test with anti-IgG or and with anti-CD3d
• Newly diagnosed Warm Autoimmune Hemolytic Anemia
• Adequate contraceptive measures for women of childbearing potential
• informed consent signed

Exclusion Criteria:

• Active infection which requires antibiotic treatment
• Pregnant or lactating women
• Epilepsy and mental illness
• Kidney and liver function abnormal

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01579110
• Other Study ID Numbers: ZXMZ2012
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Yizhou Zheng, Institute of Hematology & Blood Diseases Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Institute of Hematology & Blood Diseases Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Yizhou Zheng, doctor; Blood Diseases Hospital Chinese Academy of Medical Sciences

• PRS Account: Institute of Hematology & Blood Diseases Hospital
• Verification Date: April 2012