ThrombocytopeniaPhase 2NCT01162941
Efficacy of Helicobacter Pylori Eradication, Anti-D and Danazol Combination in Steroid Dependant or Refractory Immune Thrombocytopenia (ITP)
A Phase 2 study testing Steroid refractory ITP in people with Thrombocytopenia, run by Cooperative Study Group A for Hematology at 1 site in South Korea.
Trial summary
Proportion who would avoid splenectomy at 6 months of follow up Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopenia
- What is being tested?
- Steroid refractory ITP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2010to Jan 2012
- 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
- 1.ITP is defined by
- (a) a true thrombocytopenia on blood smear, (b) adequate megakaryopoiesis on bone marrow examination, (c) the absence of clinically apparent associated conditions or cause of thrombocytopenia
- 2.Steroid dependant ITP: more than 10 mg of prednisolone per day is required to maintain a platelet count above 20X109/L (minimum follow up duration: 3 months after diagnosis)
- 3.Steroid refractory ITP: a platelet count less than 20X109/L despite of treatment with full dose of steroid (prednisolone 1mg/kg for at least 4 weeks)
- 4.18 years old or more
Who cannot join
- 1.Patients who have a cause of thrombocytopenia such as HIV infection, lymphoproliferative disease, liver disease, definite SLE or drug
- 2.Pregnancy
- 3.Splectomized patients
- 4.Rh- blood type
- 5.Hemoglobin < 10g/dL
- 6.Known hypersensitivity to immunoglobulins
- 7.A positive direct antiglobulin test
- 8.Clinically relevant hepatic or renal disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, Asanbyeongwon-gil, Songpa-gu, 138-736
Yae-Eun Jang, nurse, 82-2-3010-6378, redpin75@paran.com
About this study
Proportion who would avoid splenectomy at 6 months of follow up
Read the detailed description
- If urea breath test (+); omeprazole 20mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 1 week. Second line Helicobacter pylori eradication will be permitted after failure of first line treatment.
- Anti-D Anti-Ro 50 μg/kg IV for 2 days (D1, 2)
- Danazol maintenance (from D1): Danazol will be continued at least 3 months. The dose of danazol can be reduced according to the adverse effects, especially in premenopausal women.
- Conditions
- Thrombocytopenia
- Being tested
- Steroid refractory ITP
- Keywords
- ITP
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steroid refractory ITPOther
Also called prednisolone 1mg/kg
a platelet count less than 20X109/L despite of treatment with full dose of steroid (prednisolone 1mg/kg for at least 4 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Steroid dependant ITP | Experimental | more than 10 mg of prednisolone per day is required to maintain a platelet count above 20X109/L (minimum follow up duration: 3 months after diagnosis) Receives: Other: Steroid refractory ITP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion who would avoid splenectomy at 6 months of follow up
Proportion who would avoid splenectomy at 6 months of follow up
Measured: 2years
Secondary outcomes (1)
SR,IR
Sustained response (platelet count that remained above 30X109/L or 2 folds of initial platelet count at 6 months of follow up) Initial response (an increase in the platelet count of at least 10X109/L or a platelet count of more than 30X109/L by day 7 after the initiation of treatment) Changes of platelet counts Safety of treatment Response rate of HP infected patients Decrement of steroid dose Predictors of response
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2011 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cooperative Study Group A for Hematology
- Sponsor type
- Research network
- Investigators
- Jung-Hee Lee, professor, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162941
- Sponsor's protocol ID
- C-019
- Status last verified
- Jul 2010
- First submitted
- 14 Jul 2010
- Last updated
- 15 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Helicobacter Pylori Eradication, Anti-D and Danazol Combination in Steroid Dependant or Refractory Immune Thrombocytopenia (ITP)
- ClinicalTrials.gov ID
- NCT01162941
- Acronym / sponsor ID
- C-019
- Conditions
- Thrombocytopenia
- Keywords
- ITP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Cooperative Study Group A for HematologyResearch network
- Study start
- Feb 2010
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 15 Jul 2010 (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.
Proportion who would avoid splenectomy at 6 months of follow up
Detailed description
- If urea breath test (+); omeprazole 20mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 1 week. Second line Helicobacter pylori eradication will be permitted after failure of first line treatment.
- Anti-D Anti-Ro 50 μg/kg IV for 2 days (D1, 2)
- Danazol maintenance (from D1): Danazol will be continued at least 3 months. The dose of danazol can be reduced according to the adverse effects, especially in premenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Steroid dependant ITP | Experimental | Other: Steroid refractory ITPmore than 10 mg of prednisolone per day is required to maintain a platelet count above 20X109/L (minimum follow up duration: 3 months after diagnosis) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1.ITP is defined by
- 2.Steroid dependant ITP: more than 10 mg of prednisolone per day is required to maintain a platelet count above 20X109/L (minimum follow up duration: 3 months after diagnosis)
- 3.Steroid refractory ITP: a platelet count less than 20X109/L despite of treatment with full dose of steroid (prednisolone 1mg/kg for at least 4 weeks)
- 4.18 years old or more
Key exclusion criteria (8 listed)
- 1.Patients who have a cause of thrombocytopenia such as HIV infection, lymphoproliferative disease, liver disease, definite SLE or drug
- 2.Pregnancy
- 3.Splectomized patients
- 4.Rh- blood type
- 5.Hemoglobin < 10g/dL
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 |
|---|---|---|
| Steroid refractory ITPAlso: prednisolone 1mg/kga platelet count less than 20X109/L despite of treatment with full dose of steroid (prednisolone 1mg/kg for at least 4 weeks) | Other | Steroid dependant ITP |
Primary outcome
Proportion who would avoid splenectomy at 6 months of follow up
Time frame: 2years
Proportion who would avoid splenectomy at 6 months of follow up
1 secondary outcome
SR,IR
Time frame: 2years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2010.
- Efficacy of Helicobacter pylori eradication, anti-D and danazol combination in steroid dependant or refractory immune thrombocytopenia (ITP)Link 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.
Jung-Hee Lee, professor principal investigator
Asan Medical Center
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 Steroid refractory ITP in people with Thrombocytopenia, run by Cooperative Study Group A for Hematology at 1 site in South Korea.
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 8 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 15 Jul 2010. 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 South Korea. 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?
Contact Sung-Hwa Bae, professor (82-53-650-4388, sunghwa@cu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion who would avoid splenectomy at 6 months of follow up (time frame: 2years). 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 15 Jul 2010.