AnemiaPhase 2NCT01579110
Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.
A Phase 2 study testing levamisole and Prednisone in people with Anemia and Anemia, Hemolytic, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Anemia, Hemolytic, Anemia, Hemolytic, Autoimmune
- What is being tested?
- levamisole and Prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Apr 2012to Apr 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Active infection which requires antibiotic treatment
- Pregnant or lactating women
- Epilepsy and mental illness
- Kidney and liver function abnormal
Trial locations and contacts
1 site in 1 country.
China1 site
Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
About this study
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.
Read the 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.
- Conditions
- Anemia, Anemia, Hemolytic, Anemia, Hemolytic, Autoimmune, Hemolysis, Hematologic Diseases, Autoimmune Diseases
- Being tested
- levamisole, Prednisone
- Keywords
- autoimmune hemolytic anemia, hemolytic anemia, Levamisole, Treatment of autoimmune hemolytic anemia, warm antibody dependant autoimmune hemolytic anemia
- Medical subject headings
- Anemia, Anemia, Hemolytic, Anemia, Hemolytic, Autoimmune, Hemolysis, Hematologic Diseases, Autoimmune Diseases, Immune System Diseases, Pathologic Processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levamisoleDrug
Levamisole 2.5mg/kg(every other day) over six months.
Prednisone 1mg/kg for two weeks and then tapered off dosage over two months.
PrednisoneDrug
Prednisone 1mg/kg for two weeks and then tapered off dosage over two months.
| Study group | Role | What they receive |
|---|---|---|
| prednisolone + levamisole | Experimental | Not described Receives: Drug: levamisole |
| Prednisone | Active comparator | Not described Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients in each group in complete or partial remission
Measured: one year
Secondary outcomes (1)
Side effects
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2015 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yizhou Zheng, Institute of Hematology & Blood Diseases Hospital, China
- Investigators
- Yizhou Zheng, doctor, Principal investigator, Blood Diseases Hospital Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579110
- Sponsor's protocol ID
- ZXMZ2012
- Status last verified
- Apr 2012
- First submitted
- 13 Apr 2012
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.
- ClinicalTrials.gov ID
- NCT01579110
- Acronym / sponsor ID
- ZXMZ2012
- Conditions
- Anemia, Anemia, Hemolytic, Anemia, Hemolytic, Autoimmune, Hemolysis, Hematologic Diseases, Autoimmune Diseases
- Keywords
- autoimmune hemolytic anemia, hemolytic anemia, Levamisole, Treatment of autoimmune hemolytic anemia, warm antibody dependant autoimmune hemolytic anemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 17 Apr 2012 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prednisolone + levamisole | Experimental | Drug: levamisole |
| Prednisone | Active comparator | Drug: Prednisone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Active infection which requires antibiotic treatment
- Pregnant or lactating women
- Epilepsy and mental illness
- Kidney and liver function abnormal
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 |
|---|---|---|
| levamisoleLevamisole 2.5mg/kg(every other day) over six months. Prednisone 1mg/kg for two weeks and then tapered off dosage over two months. | Drug | prednisolone + levamisole |
| PrednisonePrednisone 1mg/kg for two weeks and then tapered off dosage over two months. | Drug | Prednisone |
Primary outcome
Number of patients in each group in complete or partial remission
Time frame: one year
1 secondary outcome
Side effects
Time frame: 1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2012.
Related trials for Anemia
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
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.
Yizhou Zheng, doctor principal investigator
Blood Diseases Hospital Chinese Academy of Medical Sciences
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 levamisole and Prednisone in people with Anemia and Anemia, Hemolytic, run by Institute of Hematology & Blood Diseases Hospital, China 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Apr 2012. 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. 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?
Results are not available in the source record.
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?
Number of patients in each group in complete or partial remission (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2012.