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Evaluating the Safety and Efficacy of Romiplostim (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)

20. Dezember 2019 aktualisiert von: Amgen

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

45

Phase

  • Phase 2

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Part A: Romiplostim 0.2 µg/kg
Participants received 0.2 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts.
Arzneimittel: Romiplostim
Administered by subcutaneous injection
Andere Namen:
  • AMG 531
  • NPLATE
Experimental: Part A: Romiplostim 0.5 µg/kg
Participants received 0.5 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts.
Arzneimittel: Romiplostim
Administered by subcutaneous injection
Andere Namen:
  • AMG 531
  • NPLATE
Experimental: Part A: Romiplostim 1.0 µg/kg
Participants received 1.0 µg/kg romiplostim subcutaneously on day 1 and on day 15 or 22 depending on platelet counts.
Arzneimittel: Romiplostim
Administered by subcutaneous injection
Andere Namen:
  • AMG 531
  • NPLATE
Experimental: Part A: Romiplostim 3 µg/kg
Participants received 3.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts.
Arzneimittel: Romiplostim
Administered by subcutaneous injection
Andere Namen:
  • AMG 531
  • NPLATE
Experimental: Part A: Romiplostim 6 µg/kg
Participants received 6.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts.
Arzneimittel: Romiplostim
Administered by subcutaneous injection
Andere Namen:
  • AMG 531
  • NPLATE
Experimental: Part A: Romiplostim 10 µg/kg
Participants received 10.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts.
Arzneimittel: Romiplostim
Administered by subcutaneous injection
Andere Namen:
  • AMG 531
  • NPLATE
Placebo-Komparator: Part B: Placebo
Participants received placebo subcutaneously once a week for 6 weeks.
Arzneimittel: Placebo
Wird durch subkutane Injektion verabreicht
Experimental: Part B: Romiplostim 1.0 µg/kg
Participants received 1.0 µg/kg subcutaneously once a week for 6 weeks.
Arzneimittel: Romiplostim
Administered by subcutaneous injection
Andere Namen:
  • AMG 531
  • NPLATE
Experimental: Part B: Romiplostim 3.0 µg/kg
Participants received 3.0 µg/kg subcutaneously once a week for 6 weeks.
Arzneimittel: Romiplostim
Administered by subcutaneous injection
Andere Namen:
  • AMG 531
  • NPLATE
Experimental: Part B: Romiplostim 6.0 µg/kg
Participants received 6.0 µg/kg subcutaneously once a week for 6 weeks.
Arzneimittel: Romiplostim
Administered by subcutaneous injection
Andere Namen:
  • AMG 531
  • NPLATE

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Adverse Events
Zeitfenster: From first dose of study drug through 8 weeks (Part A) or 6 weeks (Part B) after last dose of study drug; 78 days
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
Zeitfenster: 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.
Assessed on day 29 (Part A only), day 43 (Part B only), and day 78

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants Who Achieved Targeted Therapeutic Platelet Level in Part A
Zeitfenster: After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)

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.
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
Zeitfenster: After first dose (day 1 to day 15 or 22), and after second dose (day 15 or 22 to day 78)
Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.
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
Zeitfenster: After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)
Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.
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
Zeitfenster: After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)
Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.
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
Zeitfenster: After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)
Platelet count data after the use of rescue medication were not included.
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
Zeitfenster: Baseline and after first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)
Platelet count data after the use of rescue medication were not included.
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
Zeitfenster: After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)
Platelet count data after the use of rescue medication were not included.
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
Zeitfenster: After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)

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.
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
Zeitfenster: Day 1 to day 78

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.
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
Zeitfenster: Day 1 to day 78
Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders.
Day 1 to day 78
Percentage of Participants With a Peak Platelet Count of ≥ 100 x 10⁹ Cells/L in Part B
Zeitfenster: Day 1 to day 78
Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders.
Day 1 to day 78
Percentage of Participants With a Peak Platelet Count of > 450 x 10⁹ Cells/L in Part B
Zeitfenster: Day 1 to day 78
Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders.
Day 1 to day 78
Percentage of Participants With a Peak Platelet Count of > 500 x 10⁹ Cells/L in Part B
Zeitfenster: Day 1 to day 78
Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders.
Day 1 to day 78
Peak Platelet Count in Part B
Zeitfenster: Day 1 to day 78
Platelet count data after administration of rescue medication were not included in the analysis.
Day 1 to day 78
Change From Baseline in Peak Platelet Count in Part B
Zeitfenster: Baseline and day 1 to day 78
Platelet count data after administration of rescue medication were not included in the analysis.
Baseline and day 1 to day 78
Time to Peak Platelet Count in Part B
Zeitfenster: Day 1 to day 78
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.
Day 1 to day 78
Duration Within the Targeted Therapeutic Platelet Range in Part B
Zeitfenster: Day 1 to day 78

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.
Day 1 to day 78

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Amgen

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Juli 2002

Primärer Abschluss (Tatsächlich)

17. Juni 2004

Studienabschluss (Tatsächlich)

17. Juni 2004

Studienanmeldedaten

Zuerst eingereicht

20. Mai 2005

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. Mai 2005

Zuerst gepostet (Schätzen)

23. Mai 2005

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. Januar 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. Dezember 2019

Zuletzt verifiziert

1. Dezember 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 20000137

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