Acquired Aplastic Anemia.Phase 3NCT01844635
Randomised Study Comparing Different Dosages of Rabbit ATG in Patients With SAA
A Phase 3 study testing Thymoglobulin in people with Acquired Aplastic Anemia., run by Nagoya University at 1 site in Japan.
Trial summary
The objective of this study is to evaluate the feasibility and effectiveness of immunosuppressive therapy (IST) using rabbit anti-thymocyte globulin (ATG) (Thymoglobuline, Genzyme) for patients with very severe aplastic anemia (VSAA) and severe aplastic anemia (SAA) as a primary therapy. Read more about this study
- Who is it for?
- Ages Up to 69 years
- Conditions the study is for
- Acquired Aplastic Anemia.
- What is being tested?
- Thymoglobulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteJapan
- Study dates
- May 2012to May 2016
- Phase
- Phase 3
- 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 Up to 69 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Acquired aplastic anemia
- Age: younger than 70 years old
- Severity: SAA, VSAA.
- Interval between diagnosis and registration <6 months.
- Written informed consent from the caretakers and/or whenever possible consent from the patient.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Department of Pediatrics, Nagoya University Graduate School of Medicine
Nagoya, Aichi-ken, 466-8550
Seiji Kojima, MD., PhD., +81-52-744-2294, kojimas@med.nagoya-u.ac.jp
Hideki Muramatsu, MD., PhD., +81-52-744-2294, hideki-muramatsu@med.nagoya-u.ac.jp
About this study
Official title: A Prospective Randomized Multicenter Study Comparing Different Dosages of Rabbit Antithymocyte Globulin (Thymoglobuline) in Patients With Severe Aplastic Anemia
The objective of this study is to evaluate the feasibility and effectiveness of immunosuppressive therapy (IST) using rabbit anti-thymocyte globulin (ATG) (Thymoglobuline, Genzyme) for patients with very severe aplastic anemia (VSAA) and severe aplastic anemia (SAA) as a primary therapy. The primary endpoint is the response rate (complete response (CR) + partial response (PR)) at day 180 after the start of IST. Secondary endpoints include evaluation of the presence and frequency of Epstein-Barr virus (EBV)-reactivation and EBV-associated lymphoproliferative disorder (EBV-LPD), Cytomegalovirus(CMV)-reactivation and CMV associated diseases, the response rate (CR+PR) on Day 360 after the start of IST, relapse rate and overall survival.
- Conditions
- Acquired Aplastic Anemia.
- Being tested
- Thymoglobulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThymoglobulinDrug
| Study group | Role | What they receive |
|---|---|---|
| 2.5 mg/kg/day of Thymoglobulin for 5 days | Experimental | 2.5 mg/kg/day of Thymoglobulin for 5 days Receives: Drug: Thymoglobulin |
| 3.5 mg/kg/day of Thymoglobulin for 5 days | Active comparator | 3.5 mg/kg/day of Thymoglobulin for 5 days Receives: Drug: Thymoglobulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematologic response (complete response (CR) or partial response (PR)) in patients with immunosuppressive therapy (IST) on day 180 after the start of IST.
Measured: day 180 after the start of IST
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startMay 2012
- Primary completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Aplastic Anemia.Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nagoya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hideki Muramatsu, Nagoya University
- Investigators
- Seiji Kojima, MD., PhD., Principal investigator, Department of Pediatrics, Nagoya University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844635
- Sponsor's protocol ID
- APBMT AAWG-01
- Status last verified
- Mar 2016
- First submitted
- 29 Apr 2013
- Last updated
- 1 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Multicenter Study Comparing Different Dosages of Rabbit Antithymocyte Globulin (Thymoglobuline) in Patients With Severe Aplastic Anemia
- ClinicalTrials.gov ID
- NCT01844635
- Acronym / sponsor ID
- APBMT AAWG-01
- Conditions
- Acquired Aplastic Anemia.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Nagoya UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2016 (estimated)
- First posted
- 1 May 2013 (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 objective of this study is to evaluate the feasibility and effectiveness of immunosuppressive therapy (IST) using rabbit anti-thymocyte globulin (ATG) (Thymoglobuline, Genzyme) for patients with very severe aplastic anemia (VSAA) and severe aplastic anemia (SAA) as a primary therapy. The primary endpoint is the response rate (complete response (CR) + partial response (PR)) at day 180 after the start of IST. Secondary endpoints include evaluation of the presence and frequency of Epstein-Barr virus (EBV)-reactivation and EBV-associated lymphoproliferative disorder (EBV-LPD), Cytomegalovirus(CMV)-reactivation and CMV associated diseases, the response rate (CR+PR) on Day 360 after the start of IST, relapse rate and overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2.5 mg/kg/day of Thymoglobulin for 5 days | Experimental | Drug: Thymoglobulin2.5 mg/kg/day of Thymoglobulin for 5 days |
| 3.5 mg/kg/day of Thymoglobulin for 5 days | Active comparator | Drug: Thymoglobulin3.5 mg/kg/day of Thymoglobulin for 5 days |
Who may qualify
- Ages
- Up to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Acquired aplastic anemia
- Age: younger than 70 years old
- Severity: SAA, VSAA.
- Interval between diagnosis and registration <6 months.
- Written informed consent from the caretakers and/or whenever possible consent from the patient.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Thymoglobulin | Drug | 2.5 mg/kg/day of Thymoglobulin for 5 days, 3.5 mg/kg/day of Thymoglobulin for 5 days |
Primary outcome
Hematologic response (complete response (CR) or partial response (PR)) in patients with immunosuppressive therapy (IST) on day 180 after the start of IST.
Time frame: day 180 after the start of IST
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
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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.
Seiji Kojima, MD., PhD. principal investigator
Department of Pediatrics, Nagoya University Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thymoglobulin in people with Acquired Aplastic Anemia., run by Nagoya University at 1 site in Japan.
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 1 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 1 Apr 2016. 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 Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Seiji Kojima, MD., PhD. (+81-52-744-2294, kojimas@med.nagoya-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematologic response (complete response (CR) or partial response (PR)) in patients with immunosuppressive therapy (IST) on day 180 after the start of IST. (time frame: day 180 after the start of IST). 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 1 Apr 2016.