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Study Complete
Sponsor ID
20010218

Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects with Immune Thrombocytopenic Purpura (ITP)

Sponsor ID
20010218
Clinicaltrials.gov ID
NCT00117143
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The purpose of this study is to assess the safety and tolerability of AMG 531 (romiplostim), a novel thrombopoiesis‐stimulating peptibody, and its effect on platelet counts in adults with immune thrombocytopenic purpura.

Additional Study Details

Phase
Phase 1/Phase 2
Product
romiplostim
Type
Interventional
Masking
None (Open Label)
Enrollment
16
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants with Adverse Events

Timeframe: From first dose through 8 weeks after last dose of study drug (11 weeks)

Number of Participants with Positive Anti-Romiplostim Antibodies

Timeframe: Days 29 and 78

Secondary Outcome Measures

Number of Participants Achieving a Targeted Therapeutic Platelet Level

Timeframe: Baseline and after first dose (days 3, 5, 8, 10, 12, 15 and days 17 and 19 for participants dosed on day 22) and after second dose (days 17, 19, and 22 for participants dosed on day 15 and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 for all participants)

Number of Participants with an Increase in Platelet Count of ≥ 20 x 10⁹/L

Timeframe: Baseline and after first dose (days 3, 5, 8, 10, 12, 15 and days 17 and 19 for participants dosed on day 22) and after second dose (days 17, 19, and 22 for participants dosed on day 15 and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 for all participants)

Number of Participants with Peak Platelet Counts of ≥ 100 x 10⁹/L

Timeframe: After first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22) and after second dose (days 17, 19, and 22 for participants dosed on day 15 and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 for all participants)

Number of Participants with Peak Platelet Counts of ≥ 450 x 10⁹/L

Timeframe: After first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22) and after second dose (days 17, 19, and 22 for participants dosed on day 15 and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 for all participants)

Change from Baseline to Peak Platelet Level

Timeframe: Baseline and after first dose (days 3, 5, 8, 10, 12, 15 and days 17 and 19 for participants dosed on day 22) and after second dose (days 17, 19, and 22 for participants dosed on day 15 and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 for all participants)

Time to Peak Platelet Count

Timeframe: From first dose of study drug to day 15 or 22, and from the date of 2nd dose of study drug (day 15 or 22) to day 78

Duration Within the Targeted Therapeutic Range

Timeframe: From first dose of study drug to day 15 or 22, and from the date of 2nd dose of study drug (day 15 or 22) to day 78

Study Documents

Study Synopsis
Available Language(s): English
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Locations

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Study Info
Age
N/A
Condition
  • Thrombocytopenia
    • Sex
    N/A
    Trial Dates
    Dec 2002 - Jul 2004
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Greater than or equal to 3 months history of ITP, regardless of splenectomy status, and completion of at least 1 prior treatment for ITP - 2 of 3 pretreatment platelet counts that were less than 30 x 10^9/L (if not currently on ITP therapy) or less than 50 x 10^9/L (if currently receiving corticosteroids for ITP therapy) - Ability to give informed consent
    Exclusion Criteria:
    - Known history of arterial thrombosis, active malignancy, or bone marrow stem cell disorder