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

20 grudnia 2019 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

45

Faza

  • Faza 2

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 65 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie sekwencyjne
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Lek: Romiplostim
Administered by subcutaneous injection
Inne nazwy:
  • AMG 531
  • NPLATE
Eksperymentalny: 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.
Lek: Romiplostim
Administered by subcutaneous injection
Inne nazwy:
  • AMG 531
  • NPLATE
Eksperymentalny: 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.
Lek: Romiplostim
Administered by subcutaneous injection
Inne nazwy:
  • AMG 531
  • NPLATE
Eksperymentalny: 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.
Lek: Romiplostim
Administered by subcutaneous injection
Inne nazwy:
  • AMG 531
  • NPLATE
Eksperymentalny: 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.
Lek: Romiplostim
Administered by subcutaneous injection
Inne nazwy:
  • AMG 531
  • NPLATE
Eksperymentalny: 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.
Lek: Romiplostim
Administered by subcutaneous injection
Inne nazwy:
  • AMG 531
  • NPLATE
Komparator placebo: Part B: Placebo
Participants received placebo subcutaneously once a week for 6 weeks.
Lek: Placebo
Podawany we wstrzyknięciu podskórnym
Eksperymentalny: Part B: Romiplostim 1.0 µg/kg
Participants received 1.0 µg/kg subcutaneously once a week for 6 weeks.
Lek: Romiplostim
Administered by subcutaneous injection
Inne nazwy:
  • AMG 531
  • NPLATE
Eksperymentalny: Part B: Romiplostim 3.0 µg/kg
Participants received 3.0 µg/kg subcutaneously once a week for 6 weeks.
Lek: Romiplostim
Administered by subcutaneous injection
Inne nazwy:
  • AMG 531
  • NPLATE
Eksperymentalny: Part B: Romiplostim 6.0 µg/kg
Participants received 6.0 µg/kg subcutaneously once a week for 6 weeks.
Lek: Romiplostim
Administered by subcutaneous injection
Inne nazwy:
  • AMG 531
  • NPLATE

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants With Adverse Events
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants Who Achieved Targeted Therapeutic Platelet Level in Part A
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Amgen

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 lipca 2002

Zakończenie podstawowe (Rzeczywisty)

17 czerwca 2004

Ukończenie studiów (Rzeczywisty)

17 czerwca 2004

Daty rejestracji na studia

Pierwszy przesłany

20 maja 2005

Pierwszy przesłany, który spełnia kryteria kontroli jakości

20 maja 2005

Pierwszy wysłany (Oszacować)

23 maja 2005

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

10 stycznia 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

20 grudnia 2019

Ostatnia weryfikacja

1 grudnia 2019

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 20000137

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