Idiopathic Thrombocytopenic PurpuraPhase 3NCT00603642
P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura
A Phase 3 study testing AMG 531 in people with Idiopathic Thrombocytopenic Purpura, run by Amgen.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of AMG 531 compared with placebo in thrombocytopenic Japanese subjects with immune (idiopathic) thrombocytopenic purpura (ITP) . Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Idiopathic Thrombocytopenic Purpura
- What is being tested?
- AMG 531
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2007to 13 Apr 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese patients with diagnosis of ITP according to the diagnostic criteria proposed by Research Committee for Idiopathic Hematopoietic Disorders of the Ministry of Health, Labour and Welfare [MHLW] (revised in 1990) at least 6 months before the first screening visit
- The mean of the 3 scheduled platelet counts taken at the scheduled visits during the screening period must be ≤ 30 x 10^9/L, with no individual count > 35 x 10^9/L
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Subjects must be ≥ 20 years of age at the time of obtaining the informed consent
- Have received at least 1 prior treatment for ITP
- If known Helicobacter pylori positive, having completed one course of Helicobacter pylori eradication therapy at least 12 weeks before the first screening visit
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- A hemoglobin value taken at scheduled visit during the screening period must be ≥ 10 g/dL
- A serum creatinine concentration taken at scheduled visit during the screening period must be ≤ 2 mg/dL
- Adequate liver function, as evidenced by a total bilirubin taken at scheduled visit during the screening period ≤ 1.5 times of the upper limit of the normal range (except for patients with a confirmed diagnosis of Gilbert's Disease) or an alanine aminotransferase and aspartate aminotransferase taken at the screening visit ≤ 3 times of the upper limit of the normal range
Who cannot join
- Any known history of bone marrow stem cell disorder. Any abnormal bone marrow findings other than those typical of ITP.
- Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years before the first screening visit.
- Documented diagnosis of arterial thrombosis (eg, stroke, transient ischemic attack, or myocardial infarction); history of venous thrombosis (eg, deep vein thrombosis, pulmonary embolism) and receiving anticoagulation therapy at the first screening visit.
- Documented diagnosis of anti phospholipid antibody syndrome
- Currently receiving any treatment for ITP except oral corticosteroids, azathioprine and/or danazol administered at a constant dose and schedule from at least 4 weeks prior to the first screening visit
- Received intravenous immunoglobulin, anti D immunoglobulin, or any drug administered to increase platelet counts (eg, immunosuppressants except azathioprine) within 2 weeks before the first screening visit
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- Have had a splenectomy for any reason within 12 weeks before the first screening visit
- Past or present participation in any study evaluating pegacaristim (polyethylene glycol-conjugated recombinant human megakaryocyte growth and development factor, KRN9000), Eltrombopag (SB 497115), recombinant human thrombopoietin, AMG 531, or other Mpl stimulation product
- Received hematopoietic growth factors (eg, granulocyte colony stimulating factor, macrophage colony stimulating factor, erythropoietin, interleukin 11) for any reason within 4 weeks before the first screening visit
- Received any anti malignancy agents (eg, cyclophosphamide, 6 mercaptopurine, vincristine, vinblastine, Interferon alfa) for any reason within 8 weeks before the first screening visit
- Received any monoclonal antibody drugs (eg, rituximab) for any reason within 14 weeks before the first screening visit
- Less than 4 weeks since receipt of any therapeutic drug or device that is not MHLW approved for any indication before the first screening visit
- Pregnant or breast feeding
- Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator
- Known severe drug hypersensitivity
- Concerns for subject's compliance with the protocol
About this study
Official title: A Randomized, Double Blind, Placebo Controlled Phase 3 Study Evaluating the Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura
The purpose of this study is to evaluate the efficacy and safety of AMG 531 compared with placebo in thrombocytopenic Japanese subjects with immune (idiopathic) thrombocytopenic purpura (ITP) .
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Being tested
- Placebo, AMG 531
- Keywords
- AMG 531, Idiopathic Thrombocytopenic Purpura, ITP, Thrombocytopenia, Japan, Placebo controlled, Phase 3
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Subcutaneously administered, once a week, for 12 weeks
AMG 531Drug
Subcutaneously administered, once a week, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| AMG 531 | Placebo comparator | Double blinded placebo-controlled study Receives: Drug: AMG 531 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weeks With Weekly Platelet Response
Number of weeks with weekly platelet response. A weekly platelet response is defined as a platelet count of ≥ 50 x 10^9/L on a weekly scheduled dose day from week 2 to week 13.
Measured: 12 weeks (Weeks 2 - 13)
Secondary outcomes (4)
Increased Platelet Count From Baseline of at Least 20 x 10^9/L
An increase in platelet count of at least 20 x 10^9/L from baseline within the participant during the treatment period. Increase was calculated as the maximum observed platelet count during the treatment period minus the baseline platelet count.
Measured: Baseline, 12 weeks (Weeks 2 - 13)
Change From Baseline in Mean of Last 4 Weekly Platelet Counts
Change from baseline in the mean of the last 4 weekly platelet counts from week 2 to week 13.
Measured: 12 weeks (Weeks 2 - 13)
Weeks With Platelet Count Between 50 and 200
Number of weeks with platelet count between 50 x 10^9/L and 200 x 10^9/L inclusive during week 2 to week 13.
Measured: 12 weeks (Weeks 2 - 13)
Rescue Medication(s)
Requirement for rescue medication(s) during treatment by the participant
Measured: 12 weeks (Weeks 2 - 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2008 (estimated)
- Study start1 Oct 2007
- Primary completion13 Apr 2009
- Study completion13 Apr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- More trials run by AmgenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603642
- Sponsor's protocol ID
- 20060216
- Status last verified
- Nov 2022
- First submitted
- 17 Jan 2008
- Last updated
- 8 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled Phase 3 Study Evaluating the Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura
- ClinicalTrials.gov ID
- NCT00603642
- Acronym / sponsor ID
- 20060216
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Keywords
- AMG 531, Idiopathic Thrombocytopenic Purpura, ITP, Thrombocytopenia, Japan, Placebo controlled, Phase 3
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2007 (actual)
- Primary completion
- 13 Apr 2009 (actual)
- Study completion
- 13 Apr 2009 (actual)
- First posted
- 29 Jan 2008 (estimated)
- Results
- Posted 10 Dec 2010
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 evaluate the efficacy and safety of AMG 531 compared with placebo in thrombocytopenic Japanese subjects with immune (idiopathic) thrombocytopenic purpura (ITP) .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMG 531 | Placebo comparator | Drug: AMG 531Double blinded placebo-controlled study |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Japanese patients with diagnosis of ITP according to the diagnostic criteria proposed by Research Committee for Idiopathic Hematopoietic Disorders of the Ministry of Health, Labour and Welfare [MHLW] (revised in 1990) at least 6 months before the first screening visit
- The mean of the 3 scheduled platelet counts taken at the scheduled visits during the screening period must be ≤ 30 x 10^9/L, with no individual count > 35 x 10^9/L
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Subjects must be ≥ 20 years of age at the time of obtaining the informed consent
- Have received at least 1 prior treatment for ITP
Key exclusion criteria (16 listed)
- Any known history of bone marrow stem cell disorder. Any abnormal bone marrow findings other than those typical of ITP.
- Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years before the first screening visit.
- Documented diagnosis of arterial thrombosis (eg, stroke, transient ischemic attack, or myocardial infarction); history of venous thrombosis (eg, deep vein thrombosis, pulmonary embolism) and receiving anticoagulation therapy at the first screening visit.
- Documented diagnosis of anti phospholipid antibody syndrome
- Currently receiving any treatment for ITP except oral corticosteroids, azathioprine and/or danazol administered at a constant dose and schedule from at least 4 weeks prior to the first screening visit
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 |
|---|---|---|
| PlaceboSubcutaneously administered, once a week, for 12 weeks | Drug | Placebo |
| AMG 531Subcutaneously administered, once a week, for 12 weeks | Drug | AMG 531 |
Primary outcome
Weeks With Weekly Platelet Response
Time frame: 12 weeks (Weeks 2 - 13)
Number of weeks with weekly platelet response. A weekly platelet response is defined as a platelet count of ≥ 50 x 10^9/L on a weekly scheduled dose day from week 2 to week 13.
4 secondary outcomes
Increased Platelet Count From Baseline of at Least 20 x 10^9/L
Time frame: Baseline, 12 weeks (Weeks 2 - 13)
Change From Baseline in Mean of Last 4 Weekly Platelet Counts
Time frame: 12 weeks (Weeks 2 - 13)
Weeks With Platelet Count Between 50 and 200
Time frame: 12 weeks (Weeks 2 - 13)
Rescue Medication(s)
Time frame: 12 weeks (Weeks 2 - 13)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink 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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AMG 531 in people with Idiopathic Thrombocytopenic Purpura, run by Amgen.
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 9 inclusion and 16 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: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 10 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Weeks With Weekly Platelet Response (time frame: 12 weeks (Weeks 2 - 13)). 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 8 Nov 2022.