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

20 dicembre 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

45

Fase

  • Fase 2

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: Romiplostim
Administered by subcutaneous injection
Altri nomi:
  • AMG 531
  • NPLATE
Sperimentale: 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.
Droga: Romiplostim
Administered by subcutaneous injection
Altri nomi:
  • AMG 531
  • NPLATE
Sperimentale: 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.
Droga: Romiplostim
Administered by subcutaneous injection
Altri nomi:
  • AMG 531
  • NPLATE
Sperimentale: 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.
Droga: Romiplostim
Administered by subcutaneous injection
Altri nomi:
  • AMG 531
  • NPLATE
Sperimentale: 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.
Droga: Romiplostim
Administered by subcutaneous injection
Altri nomi:
  • AMG 531
  • NPLATE
Sperimentale: 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.
Droga: Romiplostim
Administered by subcutaneous injection
Altri nomi:
  • AMG 531
  • NPLATE
Comparatore placebo: Part B: Placebo
Participants received placebo subcutaneously once a week for 6 weeks.
Droga: Placebo
Somministrato per iniezione sottocutanea
Sperimentale: Part B: Romiplostim 1.0 µg/kg
Participants received 1.0 µg/kg subcutaneously once a week for 6 weeks.
Droga: Romiplostim
Administered by subcutaneous injection
Altri nomi:
  • AMG 531
  • NPLATE
Sperimentale: Part B: Romiplostim 3.0 µg/kg
Participants received 3.0 µg/kg subcutaneously once a week for 6 weeks.
Droga: Romiplostim
Administered by subcutaneous injection
Altri nomi:
  • AMG 531
  • NPLATE
Sperimentale: Part B: Romiplostim 6.0 µg/kg
Participants received 6.0 µg/kg subcutaneously once a week for 6 weeks.
Droga: Romiplostim
Administered by subcutaneous injection
Altri nomi:
  • AMG 531
  • NPLATE

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Adverse Events
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants Who Achieved Targeted Therapeutic Platelet Level in Part A
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Amgen

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 luglio 2002

Completamento primario (Effettivo)

17 giugno 2004

Completamento dello studio (Effettivo)

17 giugno 2004

Date di iscrizione allo studio

Primo inviato

20 maggio 2005

Primo inviato che soddisfa i criteri di controllo qualità

20 maggio 2005

Primo Inserito (Stima)

23 maggio 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 gennaio 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 dicembre 2019

Ultimo verificato

1 dicembre 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 20000137

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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