Paroxysmal Nocturnal HemoglobinuriaPhase 2PNH-2012NCT01642979
Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal Hemoglobinuria
A Phase 2 study testing Levamisole+cyclosporin A+Glucocorticoids, cyclosporin A+Glucocorticoids and Glucocorticoids in people with Paroxysmal Nocturnal Hemoglobinuria and Hemoglobinuria, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
Paroxysmal nocturnal hemoglobinuria is an acquired chronic hemolytic anemia,this study is designed to evaluate the safety and efficacy of Levamisole combined with cyclosporine A in patients with classic paroxysmal nocturnal hemoglobinuria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Nocturnal Hemoglobinuria, Hemoglobinuria, Hemoglobinuria, Paroxysmal
- What is being tested?
- Levamisole+cyclosporin A+Glucocorticoids, cyclosporin A+Glucocorticoids and Glucocorticoids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Jul 2017
- 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 classic Paroxysmal Nocturnal Hemoglobinuria
- Diagnosis confirmed by Ham's test or Flow cytometry Patients have any Flow cytometry data
- patient should complete levamisole study for at least half a year
Who cannot join
- Active infection which requires antibiotic treatment
- Pregnant or lactating women
- Epilepsy and mental illness
- Kidney and liver function abnormal
- patient who terminate ealy from levamisole study
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Hematology & Blood Diseases Hospital,
Tianjin, Tianjin Municipality, 300020
About this study
Official title: Phase II Study of the Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal Hemoglobinuria
Paroxysmal nocturnal hemoglobinuria is an acquired chronic hemolytic anemia,this study is designed to evaluate the safety and efficacy of Levamisole combined with cyclosporine A in patients with classic paroxysmal nocturnal hemoglobinuria.
Read the detailed description
Paroxysmal nocturnal hemoglobinuria (PNH) is an acquired clonal disorder of the hematopoietic stem cell characterized by intravascular hemolysis, hemoglobinuria, anemia, and thrombosis, Patients may be at high risk of thrombosis and may develop bone marrow failure or aplastic anemia, with low white blood cell and platelet counts,because the manifestation and pathologic processes are complicate,the treatment is very difficult,this study is designed to evaluate the safety and efficacy of Levamisole combined with cyclosporine A in patients with classic paroxysmal nocturnal hemoglobinuria
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria, Hemoglobinuria, Hemoglobinuria, Paroxysmal, Proteinuria, Urination Disorders, Thrombosis
- Being tested
- Levamisole+cyclosporin A+Glucocorticoids, cyclosporin A+Glucocorticoids, Glucocorticoids
- Keywords
- Paroxysmal Nocturnal Hemoglobinuria, Anemia, Hematologic Diseases, bone marrow failure, Immunologic Factors, Physiological Effects of Drugs, Levamisole, cyclosporine A
- Medical subject headings
- Hemoglobinuria, Paroxysmal, Hemoglobinuria, Proteinuria, Urination Disorders, Thrombosis, Bone Marrow Failure Disorders, Anemia, Aplastic, Anemia, Hemolytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levamisole+cyclosporin A+GlucocorticoidsDrug
Also called Levamisole, cyclosporin A, Glucocorticoids
Levamisole 2.5mg/kg every other day cyclosporin A 1.5-2.5mg/kg every other day Glucocorticoids0.5-1mg/kg every day(prednisone)
cyclosporin A+GlucocorticoidsDrug
Also called cyclosporin A, Glucocorticoids
cyclosporin A 1.5-2.5mg/kg every day Glucocorticoids0.5-1mg/kg every day(prednisone)
GlucocorticoidsDrug
Glucocorticoids 0.5-1mg/kg every day(prednisone)
| Study group | Role | What they receive |
|---|---|---|
| Levamisole+cyclosporin A+Glucocorticoids | Experimental | Levamisole+cyclosporin A+Glucocorticoids Receives: Drug: Levamisole+cyclosporin A+Glucocorticoids |
| cyclosporin A+Glucocorticoids | Active comparator | cyclosporin A+Glucocorticoids Receives: Drug: cyclosporin A+Glucocorticoids |
| Glucocorticoids | Active comparator | Glucocorticoids Receives: Drug: Glucocorticoids |
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
she got blood transfusion-independent,the hemoglobin became higher
Measured: 6 months
Secondary outcomes (1)
Side effects
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2016 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal Nocturnal HemoglobinuriaStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 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, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642979
- Sponsor's protocol ID
- PNH-2012
- Acronym
- PNH-2012
- Status last verified
- Jan 2013
- First submitted
- 14 Jul 2012
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Parker C, Omine M, Richards S, Nishimura J, Bessler M, Ware R, Hillmen P, Luzzatto L, Young N, Kinoshita T, Rosse W, Socie G; International PNH Interest Group. Diagnosis and management of paroxysmal nocturnal hemoglobinuria. Blood. 2005 Dec 1;106(12):3699-709. doi: 10.1182/blood-2005-04-1717. Epub 2005 Jul 28. No abstract available.
PubMed 16051736
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of the Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal Hemoglobinuria
- ClinicalTrials.gov ID
- NCT01642979
- Acronym / sponsor ID
- PNH-2012 / PNH-2012
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria, Hemoglobinuria, Hemoglobinuria, Paroxysmal, Proteinuria, Urination Disorders, Thrombosis
- Keywords
- Paroxysmal Nocturnal Hemoglobinuria, Anemia, Hematologic Diseases, bone marrow failure, Immunologic Factors, Physiological Effects of Drugs, Levamisole, cyclosporine A
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 17 Jul 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.
Paroxysmal nocturnal hemoglobinuria is an acquired chronic hemolytic anemia,this study is designed to evaluate the safety and efficacy of Levamisole combined with cyclosporine A in patients with classic paroxysmal nocturnal hemoglobinuria.
Detailed description
Paroxysmal nocturnal hemoglobinuria (PNH) is an acquired clonal disorder of the hematopoietic stem cell characterized by intravascular hemolysis, hemoglobinuria, anemia, and thrombosis, Patients may be at high risk of thrombosis and may develop bone marrow failure or aplastic anemia, with low white blood cell and platelet counts,because the manifestation and pathologic processes are complicate,the treatment is very difficult,this study is designed to evaluate the safety and efficacy of Levamisole combined with cyclosporine A in patients with classic paroxysmal nocturnal hemoglobinuria
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Levamisole+cyclosporin A+Glucocorticoids | Experimental | Drug: Levamisole+cyclosporin A+GlucocorticoidsLevamisole+cyclosporin A+Glucocorticoids |
| cyclosporin A+Glucocorticoids | Active comparator | Drug: cyclosporin A+Glucocorticoidscyclosporin A+Glucocorticoids |
| Glucocorticoids | Active comparator | Drug: GlucocorticoidsGlucocorticoids |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical and biochemical signs of classic Paroxysmal Nocturnal Hemoglobinuria
- Diagnosis confirmed by Ham's test or Flow cytometry Patients have any Flow cytometry data
- patient should complete levamisole study for at least half a year
Key exclusion criteria (5 listed)
- Active infection which requires antibiotic treatment
- Pregnant or lactating women
- Epilepsy and mental illness
- Kidney and liver function abnormal
- patient who terminate ealy from levamisole study
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 |
|---|---|---|
| Levamisole+cyclosporin A+GlucocorticoidsAlso: Levamisole, cyclosporin A, GlucocorticoidsLevamisole 2.5mg/kg every other day cyclosporin A 1.5-2.5mg/kg every other day Glucocorticoids0.5-1mg/kg every day(prednisone) | Drug | Levamisole+cyclosporin A+Glucocorticoids |
| cyclosporin A+GlucocorticoidsAlso: cyclosporin A, Glucocorticoidscyclosporin A 1.5-2.5mg/kg every day Glucocorticoids0.5-1mg/kg every day(prednisone) | Drug | cyclosporin A+Glucocorticoids |
| GlucocorticoidsGlucocorticoids 0.5-1mg/kg every day(prednisone) | Drug | Glucocorticoids |
Primary outcome
Number of patients in each group in complete or partial remission
Time frame: 6 months
she got blood transfusion-independent,the hemoglobin became higher
1 secondary outcome
Side effects
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
- Background: PubMed 16051736Parker C, Omine M, Richards S, Nishimura J, Bessler M, Ware R, Hillmen P, Luzzatto L, Young N, Kinoshita T, Rosse W, Socie G; International PNH Interest Group. Diagnosis and management of paroxysmal nocturnal hemoglobinuria. Blood. 2005 Dec 1;106(12):3699-709. doi: 10.1182/blood-2005-04-1717. Epub 2005 Jul 28. No abstract available.
- CBDLink 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.
yizhou zheng, doctor principal investigator
Institute of Hematology & Blood Diseases Hospital, China
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+cyclosporin A+Glucocorticoids, cyclosporin A+Glucocorticoids and Glucocorticoids in people with Paroxysmal Nocturnal Hemoglobinuria and Hemoglobinuria, 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 3 inclusion and 5 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 3 Jan 2013. 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: 6 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 NCT01642979, which also lists 1 linked publication.
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 3 Jan 2013.