Idiopathic Thrombocytopenic PurpuraPhase 2NCT00111475
Evaluating the Safety and Efficacy of Romiplostim (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)
A Phase 2 study testing Romiplostim in people with Idiopathic Thrombocytopenic Purpura, run by Amgen.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with ITP. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Idiopathic Thrombocytopenic Purpura
- What is being tested?
- Romiplostim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2002to 17 Jun 2004
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ITP according to American Society of Hematology (ASH) guidelines at least 3 months before enrollment
- Have completed at least 1 prior treatment for ITP
- Two (including day -2) of the 3 platelet counts taken during the screening and pre-treatment periods must have fulfilled the following:
- less than 30 x 10^9/L for those subjects not receiving any ITP therapy,
- less than 50 x 10^9/L for those subjects receiving any ITP therapy
- Eastern Cooperative Oncology Group performance status of 0 to 2
Show all 10Show fewer
- Serum creatinine concentration ≤ 2 mg/dL (≤ 176.8 µmol/L)
- Adequate liver function, as evidenced by a serum bilirubin ≤ 1.5 times the laboratory normal range
- Hemoglobin greater than 10.0 g/dL
- Written informed consent
Who cannot join
- Considered a substantial risk for adverse outcomes because of a clinically important trend (as determined by the investigator) detected in the platelet counts during the screening period
- Any known history of bone marrow stem cell disorder
- 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 randomization
- Documented diagnosis of arterial thrombosis (ie, stroke, transient ischemic attack, or myocardial infarction) in the previous year; history of venous thrombosis (ie, deep vein thrombosis, pulmonary embolism) and receiving anticoagulation therapy
- Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure [New York Heart Association (NYHA) greater than class II], uncontrolled hypertension [diastolic greater than 100 mmHg] or cardiac arrhythmia)
- Have 3 or more of the following predisposing factors for thromboembolic events: diabetes; smoker using oral contraceptives; hypercholesteremia (> 240 mg/dL); treatment for hypertension
Show all 17Show fewer
- Known positive test for human immunodeficiency virus (HIV) infection or hepatitis C virus
- Received any treatment for ITP (except for a constant dose schedule of corticosteroids) within 4 weeks before the screening visit
- Received intravenous (IV) immunoglobulin (Ig) or WinRho within 2 weeks before the screening visit
- Received hematopoietic growth factors, including interleukin (IL)-11 (Neumega®) within 4 weeks before the screening visit
- Past or present participation in any study evaluating polyethylene glycol recombinant human magakaryopoiesis differentiating factor (PEG-rHuMGDF), recombinant human thrombopoietin (rHuTPO), or related platelet product
- Received any alkylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study
- Received any monoclonal antibody (eg, rituximab) within 16 weeks before the screening visit or anticipated use during the time of the proposed study
- Less than 4 weeks since receipt of any therapeutic drug or device that is not FDA approved for any indication before the screening period
- Less than 2 months since major surgery (including laparoscopic splenectomy)
- Pregnant or breast feeding
- Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator
About this study
Official title: A Dose-finding Study Evaluating the Safety and Efficacy of AMG 531 in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)
The primary objective of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with ITP.
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Being tested
- Romiplostim, Placebo
- Keywords
- Immune Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura, Thrombocytopenic, Thrombocytopenia, ITP
- 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.
RomiplostimDrug
Also called AMG 531, NPLATE
Administered by subcutaneous injection
PlaceboDrug
Administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Part A: Romiplostim 0.2 µg/kg | Experimental | Participants received 0.2 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. Receives: Drug: Romiplostim |
| Part A: Romiplostim 0.5 µg/kg | Experimental | Participants received 0.5 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. Receives: Drug: Romiplostim |
| Part A: Romiplostim 1.0 µg/kg | Experimental | Participants received 1.0 µg/kg romiplostim subcutaneously on day 1 and on day 15 or 22 depending on platelet counts. Receives: Drug: Romiplostim |
| Part A: Romiplostim 3 µg/kg | Experimental | Participants received 3.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. Receives: Drug: Romiplostim |
| Part A: Romiplostim 6 µg/kg | Experimental | Participants received 6.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. Receives: Drug: Romiplostim |
| Part A: Romiplostim 10 µg/kg | Experimental | Participants received 10.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. Receives: Drug: Romiplostim |
| Part B: Placebo | Placebo comparator | Participants received placebo subcutaneously once a week for 6 weeks. Receives: Drug: Placebo |
| Part B: Romiplostim 1.0 µg/kg | Experimental | Participants received 1.0 µg/kg subcutaneously once a week for 6 weeks. Receives: Drug: Romiplostim |
| Part B: Romiplostim 3.0 µg/kg | Experimental | Participants received 3.0 µg/kg subcutaneously once a week for 6 weeks. Receives: Drug: Romiplostim |
| Part B: Romiplostim 6.0 µg/kg | Experimental | Participants received 6.0 µg/kg subcutaneously once a week for 6 weeks. Receives: Drug: Romiplostim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Measured: From first dose of study drug through 8 weeks (Part A) or 6 weeks (Part B) after last dose of study drug; 78 days
Number of Participants With Anti-romiplostim or Anti-endogenous Thrombopoietin Neutralizing Antibodies
The development of antibodies to romiplostim or to endogenous thrombopoietin (eTPO) was assessed using a neutralizing bioassay. Participants positive for neutralizing antibodies at any of the assessments during the study are reported.
Measured: Assessed on day 29 (Part A only), day 43 (Part B only), and day 78
Secondary outcomes (17)
Number of Participants Who Achieved Targeted Therapeutic Platelet Level in Part A
Targeted therapeutic platelet level was defined as a doubling of baseline platelet counts and between 50 to 450 x 10⁹ cells/L.
Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.
Measured: After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)
Number of Participants With an Increase in Platelet Count of ≥ 20 x 10⁹ Cells/L Over Baseline in Part A
Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.
Measured: After first dose (day 1 to day 15 or 22), and after second dose (day 15 or 22 to day 78)
Number of Participants With a Peak Platelet Count ≥ 100 x 10⁹ Cells/L in Part A
Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.
Measured: After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)
Number of Participants With a Peak Platelet Count of > 450 x 10⁹ Cells/L in Part A
Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.
Measured: After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)
Peak Platelet Count After Each Dose in Part A
Platelet count data after the use of rescue medication were not included.
Measured: After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)
Change From Baseline in Peak Platelet Count After Each Dose in Part A
Platelet count data after the use of rescue medication were not included.
Measured: Baseline and after first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)
Time to Peak Platelet Count After Each Dose in Part A
Platelet count data after the use of rescue medication were not included.
Measured: After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)
Duration Within the Targeted Therapeutic Platelet Range In Part A
Targeted therapeutic platelet level was defined as a platelet count that was double the baseline level and ≥ 50 and ≤ 450 × 10⁹ cells/L.
Platelet count data after the use of rescue medication were not included.
Measured: After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)
Percentage of Participants Who Achieved Targeted Therapeutic Platelet Level In Part B
Targeted therapeutic platelet level was defined as a doubling of baseline platelet counts and within the range of greater than or equal to 50 x 10⁹ cells/L and less than or equal to 450 x 10⁹ cells/L.
Platelet count data after use of rescue medication were not included in the analysis.
Measured: Day 1 to day 78
Percentage of Participants With an Increase in Platelet Count of ≥ 20 x 10⁹ Cells/L Over Baseline in Part B
Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders.
Measured: Day 1 to day 78
Percentage of Participants With a Peak Platelet Count of ≥ 100 x 10⁹ Cells/L in Part B
Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders.
Measured: Day 1 to day 78
Percentage of Participants With a Peak Platelet Count of > 450 x 10⁹ Cells/L in Part B
Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders.
Measured: Day 1 to day 78
Percentage of Participants With a Peak Platelet Count of > 500 x 10⁹ Cells/L in Part B
Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders.
Measured: Day 1 to day 78
Peak Platelet Count in Part B
Platelet count data after administration of rescue medication were not included in the analysis.
Measured: Day 1 to day 78
Change From Baseline in Peak Platelet Count in Part B
Platelet count data after administration of rescue medication were not included in the analysis.
Measured: Baseline and day 1 to day 78
Time to Peak Platelet Count in Part B
Platelet count data after administration of rescue medication were not included in the analysis. Time to peak platelet count was analyzed using the Kaplan-Meier method.
Measured: Day 1 to day 78
Duration Within the Targeted Therapeutic Platelet Range in Part B
Targeted therapeutic platelet level was defined as a doubling of baseline platelet counts and within the range of greater than or equal to 50 × 10⁹ cells/L and less than or equal to 450 × 10⁹ cells/L.
Platelet count data after administration of rescue medication were not included in the analysis.
Measured: Day 1 to day 78
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2005 (estimated)
- Study start1 Jul 2002
- Primary completion17 Jun 2004
- Study completion17 Jun 2004
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part A was a sequential cohort dose escalation study. Part B was a randomized, placebo-controlled parallel group study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 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
- NCT00111475
- Sponsor's protocol ID
- 20000137
- Status last verified
- Dec 2019
- First submitted
- 20 May 2005
- Last updated
- 10 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Cines DB, Wasser J, Rodeghiero F, Chong BH, Steurer M, Provan D, Lyons R, Garcia-Chavez J, Carpenter N, Wang X, Eisen M. Safety and efficacy of romiplostim in splenectomized and nonsplenectomized patients with primary immune thrombocytopenia. Haematologica. 2017 Aug;102(8):1342-1351. doi: 10.3324/haematol.2016.161968. Epub 2017 Apr 14.
PubMed 28411254Bussel JB, Kuter DJ, George JN, McMillan R, Aledort LM, Conklin GT, Lichtin AE, Lyons RM, Nieva J, Wasser JS, Wiznitzer I, Kelly R, Chen CF, Nichol JL. AMG 531, a thrombopoiesis-stimulating protein, for chronic ITP. N Engl J Med. 2006 Oct 19;355(16):1672-81. doi: 10.1056/NEJMoa054626.
PubMed 17050891
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-finding Study Evaluating the Safety and Efficacy of AMG 531 in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)
- ClinicalTrials.gov ID
- NCT00111475
- Acronym / sponsor ID
- 20000137
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Keywords
- Immune Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura, Thrombocytopenic, Thrombocytopenia, ITP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2002 (actual)
- Primary completion
- 17 Jun 2004 (actual)
- Study completion
- 17 Jun 2004 (actual)
- First posted
- 23 May 2005 (estimated)
- Results
- Posted 10 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with ITP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
- Model description
- Part A was a sequential cohort dose escalation study. Part B was a randomized, placebo-controlled parallel group study.
| Arm | Type | Receives |
|---|---|---|
| Part A: Romiplostim 0.2 µg/kg | Experimental | Drug: RomiplostimParticipants received 0.2 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. |
| Part A: Romiplostim 0.5 µg/kg | Experimental | Drug: RomiplostimParticipants received 0.5 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. |
| Part A: Romiplostim 1.0 µg/kg | Experimental | Drug: RomiplostimParticipants received 1.0 µg/kg romiplostim subcutaneously on day 1 and on day 15 or 22 depending on platelet counts. |
| Part A: Romiplostim 3 µg/kg | Experimental | Drug: RomiplostimParticipants received 3.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. |
| Part A: Romiplostim 6 µg/kg | Experimental | Drug: RomiplostimParticipants received 6.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. |
| Part A: Romiplostim 10 µg/kg | Experimental | Drug: RomiplostimParticipants received 10.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. |
| Part B: Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo subcutaneously once a week for 6 weeks. |
| Part B: Romiplostim 1.0 µg/kg | Experimental | Drug: RomiplostimParticipants received 1.0 µg/kg subcutaneously once a week for 6 weeks. |
| Part B: Romiplostim 3.0 µg/kg | Experimental | Drug: RomiplostimParticipants received 3.0 µg/kg subcutaneously once a week for 6 weeks. |
| Part B: Romiplostim 6.0 µg/kg | Experimental | Drug: RomiplostimParticipants received 6.0 µg/kg subcutaneously once a week for 6 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of ITP according to American Society of Hematology (ASH) guidelines at least 3 months before enrollment
- Have completed at least 1 prior treatment for ITP
- Two (including day -2) of the 3 platelet counts taken during the screening and pre-treatment periods must have fulfilled the following:
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Serum creatinine concentration ≤ 2 mg/dL (≤ 176.8 µmol/L)
Key exclusion criteria (17 listed)
- Considered a substantial risk for adverse outcomes because of a clinically important trend (as determined by the investigator) detected in the platelet counts during the screening period
- Any known history of bone marrow stem cell disorder
- 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 randomization
- Documented diagnosis of arterial thrombosis (ie, stroke, transient ischemic attack, or myocardial infarction) in the previous year; history of venous thrombosis (ie, deep vein thrombosis, pulmonary embolism) and receiving anticoagulation therapy
- Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure [New York Heart Association (NYHA) greater than class II], uncontrolled hypertension [diastolic greater than 100 mmHg] or cardiac arrhythmia)
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 |
|---|---|---|
| RomiplostimAlso: AMG 531, NPLATEAdministered by subcutaneous injection | Drug | Part A: Romiplostim 0.2 µg/kg, Part A: Romiplostim 0.5 µg/kg, Part A: Romiplostim 1.0 µg/kg, Part A: Romiplostim 10 µg/kg, Part A: Romiplostim 3 µg/kg, Part A: Romiplostim 6 µg/kg, Part B: Romiplostim 1.0 µg/kg, Part B: Romiplostim 3.0 µg/kg, Part B: Romiplostim 6.0 µg/kg |
| PlaceboAdministered by subcutaneous injection | Drug | Part B: Placebo |
Primary outcome
Number of Participants With Adverse Events
Time frame: From first dose of study drug through 8 weeks (Part A) or 6 weeks (Part B) after last dose of study drug; 78 days
Number of Participants With Anti-romiplostim or Anti-endogenous Thrombopoietin Neutralizing Antibodies
Time frame: Assessed on day 29 (Part A only), day 43 (Part B only), and day 78
The development of antibodies to romiplostim or to endogenous thrombopoietin (eTPO) was assessed using a neutralizing bioassay. Participants positive for neutralizing antibodies at any of the assessments during the study are reported.
17 secondary outcomes
Number of Participants Who Achieved Targeted Therapeutic Platelet Level in Part A
Time frame: After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)
Number of Participants With an Increase in Platelet Count of ≥ 20 x 10⁹ Cells/L Over Baseline in Part A
Time frame: After first dose (day 1 to day 15 or 22), and after second dose (day 15 or 22 to day 78)
Number of Participants With a Peak Platelet Count ≥ 100 x 10⁹ Cells/L in Part A
Time frame: After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)
Number of Participants With a Peak Platelet Count of > 450 x 10⁹ Cells/L in Part A
Time frame: After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)
Peak Platelet Count After Each Dose in Part A
Time frame: After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)
Change From Baseline in Peak Platelet Count After Each Dose in Part A
Time frame: Baseline and after first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)
Time to Peak Platelet Count After Each Dose in Part A
Time frame: After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)
Duration Within the Targeted Therapeutic Platelet Range In Part A
Time frame: After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)
Percentage of Participants Who Achieved Targeted Therapeutic Platelet Level In Part B
Time frame: Day 1 to day 78
Percentage of Participants With an Increase in Platelet Count of ≥ 20 x 10⁹ Cells/L Over Baseline in Part B
Time frame: Day 1 to day 78
Percentage of Participants With a Peak Platelet Count of ≥ 100 x 10⁹ Cells/L in Part B
Time frame: Day 1 to day 78
Percentage of Participants With a Peak Platelet Count of > 450 x 10⁹ Cells/L in Part B
Time frame: Day 1 to day 78
Percentage of Participants With a Peak Platelet Count of > 500 x 10⁹ Cells/L in Part B
Time frame: Day 1 to day 78
Peak Platelet Count in Part B
Time frame: Day 1 to day 78
Change From Baseline in Peak Platelet Count in Part B
Time frame: Baseline and day 1 to day 78
Time to Peak Platelet Count in Part B
Time frame: Day 1 to day 78
Duration Within the Targeted Therapeutic Platelet Range in Part B
Time frame: Day 1 to day 78
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28411254Cines DB, Wasser J, Rodeghiero F, Chong BH, Steurer M, Provan D, Lyons R, Garcia-Chavez J, Carpenter N, Wang X, Eisen M. Safety and efficacy of romiplostim in splenectomized and nonsplenectomized patients with primary immune thrombocytopenia. Haematologica. 2017 Aug;102(8):1342-1351. doi: 10.3324/haematol.2016.161968. Epub 2017 Apr 14.
- Background: PubMed 17050891Bussel JB, Kuter DJ, George JN, McMillan R, Aledort LM, Conklin GT, Lichtin AE, Lyons RM, Nieva J, Wasser JS, Wiznitzer I, Kelly R, Chen CF, Nichol JL. AMG 531, a thrombopoiesis-stimulating protein, for chronic ITP. N Engl J Med. 2006 Oct 19;355(16):1672-81. doi: 10.1056/NEJMoa054626.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- FDA-approved Drug LabelingLink 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 2 study testing Romiplostim 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 10 inclusion and 17 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 10 Jan 2020. 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 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?
Yes. Results are posted in the registry (first posted 10 Jan 2020). 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?
Number of Participants With Adverse Events (time frame: From first dose of study drug through 8 weeks (Part A) or 6 weeks (Part B) after last dose of study drug; 78 days). The study lists 2 primary outcomes in all. 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 NCT00111475, which also lists 2 linked publications.
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 10 Jan 2020.