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Immune (Idiopathic) Thrombocytopenic Purpura (ITP)Phase 2/3NCT00440037

Open Label Extension Study of AMG 531 in Japanese Subjects With ITP

A Phase 2/3 study testing AMG 531 in people with Immune (Idiopathic) Thrombocytopenic Purpura (ITP), run by Kyowa Kirin Co., Ltd. at 13 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the safety and efficacy of long term dosing of AMG 531 in thrombocytopenic Japanese subjects with ITP. It is anticipated that AMG 531 will be a safe and well tolerated in long term treatment and that AMG 531 will effectively raise and maintain platelet counts to a desired… Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
AMG 531
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
13 sitesJapan
Study dates
Nov 2006to Sep 2011
Phase
Phase 2/3
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must have previously completed an AMG 531 ITP study in Japan.
  • Platelet count taken at the screening visit must be < 50 x 109/L.
  • Before any study-specific procedure, the appropriate written informed consent must be obtained.

Who cannot join

  • Any significant change in medical history since completion of the previous AMG 531 ITP study including bone marrow stem cell disorders or new active malignancies
  • known positive result from a test for neutralizing antibodies to AMG 531 in the previous AMG 531 ITP study
  • Currently receiving any treatment for ITP except oral corticosteroids, azathioprine and/or danazol administered at a constant dose and schedule from at least 4 weeks prior to the screening visit
  • received intravenous immunoglobulin, anti-D immunoglobulin, or any drug administered to increase platelet counts (eg, immunosuppressants etc) within 1 week before the screening visit
  • received anti-malignancy agents (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, Interferon-alfa etc) within 4 weeks before the screening visit
  • received any monoclonal antibody drugs (eg, rituximab etc) within 8 weeks before the screening visit
Show all 11Show fewer
  • Less than 4 weeks since receipt of any therapeutic drug or device that is not Ministry of Health, Labor and Welfare (MHLW) approved for any indication before the screening visit (excluding AMG 531)
  • Pregnant or breast feeding
  • Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator
  • known severe drug hypersensitivity
  • Concerns for subject's compliance with the protocol

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Japan13 sites

  • Research Site

    Chūō, 409-3898

  • Research Site

    Hirakata, 573-1191

  • Research Site

    Hiroshima, 730-8619

  • Research Site

    Isehara-shi, Kanagawa, 259-1193

  • Research Site

    Kumamoto, 860-8556

  • Research Site

    Moriguchi, 570-8507

  • Research Site

    Sagamihara, Kanagawa, 228-8555

  • Research Site

    Sapporo, Hokkaido, 060-8648

  • Research Site

    Suita, Osaka, 565-0871

  • Research Site

    Tokyo, 113-8655

  • Research Site

    Tokyo, 141-8625

  • Research Site

    Tokyo, 160-8585

  • Research Site

    Tsukuba, Ibaraki, 305-8576

Other trials in Japan

About this study

Official title: An Open Label Extension Study Evaluating the Safety and Efficacy of Long Term Dosing of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura

The purpose of this study is to assess the safety and efficacy of long term dosing of AMG 531 in thrombocytopenic Japanese subjects with ITP.

It is anticipated that AMG 531 will be a safe and well tolerated in long term treatment and that AMG 531 will effectively raise and maintain platelet counts to a desired therapeutic range, when individual dose adjustments based on platelet counts are permitted.

This study is available to subjects who have completed any previous AMG 531 ITP study in Japan and meet the eligibility criteria of this study.

Read the detailed description

Romiplostim was administered by subcutaneous (SC) injection once per week. If subjects entered the extension study within 12 weeks from the last investigational product administration in the previous study and had shown an increase in platelet counts ≥ 20 x 109/L from baseline at least once during the 13-week treatment period (excluding 4 weeks after receiving rescue medication), they were treated with romiplostim at the same weekly dose (last dose on study) received in the previous study. Otherwise, subjects were treated with romiplostim at a starting dose of 3 μg/kg. Dose adjustment based on platelet counts was allowed throughout the treatment period to allow subjects to maintain platelet counts in the target range of ≥ 50 to ≤ 200 x 109/L, up to a maximum permitted dose of 10 μg/kg.

Being tested
AMG 531
Keywords
AMG 531, ITP, Long term treatment, Japanese, Romiplostim
Medical subject headings
Purpura, Thrombocytopenic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMG 531Biological

    Also called Romiplostim

    AMG 531 will be administered by SC injection once per week from Week 1 (Day 1). The maximum permitted dose of AMG 531 is 10 μg/kg. AMG 531 will be supplied as a sterile, white, preservative-free, lyophilized powder in 5 mL glass vials containing 0.6 mg of protein per vial, and a protein concentration of 0.5 mg/mL when reconstituted with 1.2 mL of sterile water for injection.

Study groups in NCT00440037
Study groupRoleWhat they receive
AMG 531ExperimentalNot described
Receives: Biological: AMG 531

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Adverse Events Including Clinically Significant Changes in Laboratory Values.

    Subjects who reported at least 1 adverse event after beginning treatment with romiplostim in this study

    Measured: Through study completion, the median treatment duration (time between first dose and last dose) was 146.0 weeks (range: 12 to 243 weeks)

Secondary outcomes (4)

  1. Incidence of Anti AMG 531 Antibody Formation

    Subjects with positive anti-AMG 531 antibodies (either to the peptide portion of AMG 531 or to the intact molecule) and antibodies that cross-react with endogenous thrombopoietin (TPO)

    Measured: Through study completion, the median treatment duration (time between first dose and last dose) was 146.0 weeks (range: 12 to 243 weeks)

  2. Incidence of Platelet Response (Platelet Response is Defined as a Doubling of Baseline Platelet Counts and More Than 50 x 10^9/L; Baseline Platelet Counts is That Obtained in the Previous Study)

    Measured: Through study completion, the median treatment duration (time between first dose and last dose) was 146.0 weeks (range: 12 to 243 weeks)

  3. Percentage of Subjects Able to Reduce or Discontinue Their Concurrent ITP Therapies (for Subjects That Are Receiving Oral Corticosteroids at a Constant Dose and Schedule at the Screening Visit)

    Measured: Through study completion, the median treatment duration (time between first dose and last dose) was 146.0 weeks (range: 12 to 243 weeks)

  4. Change From Baseline in Patient-reported Outcome (PRO) Endpoints at Each Time Point (Baseline PRO is Obtained at Day 1 Predose)

    Short Form 36 (SF-36): The SF-36 has 36 questions with 8 domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health. In addition to deriving a score for each of the domains, the SF-36 generates 2 summary scores: a physical component summary (PCS) and a mental component summary (MCS). These 8 domains and 2 summary scores are scored from 0 to 100, with higher scores indicating better health status. The official version in Japanese was used in this study.

    Euroqol-5 Dimensions (EQ-5D): The EQ-5D is a patient-completed, multidimensional measure of HRQOL. EQ-5D index values range from -0.59 to 1.00. The EQ-5D visual analogue scale (VAS) records the respondents' self-rated health status on a vertical graduated (0 to 100) visual analogue scale. Higher EQ-5D Index and VAS scores represent better health status. The official version in Japanese was used in this study.

    Measured: By Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2007 (estimated)
  2. Study startNov 2006
  3. Primary completionJul 2011
  4. Study completionSep 2011

Resources

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 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00440037
Sponsor's protocol ID
20060113
Other IDs
Japan CT Notification 18-1055
Status last verified
Jan 2020
First submitted
22 Feb 2007
Last updated
21 Jan 2020
Data monitoring committee
No

Publications

  • Arranz R, Garcia-Noblejas A, Grande C, Cannata-Ortiz J, Sanchez JJ, Garcia-Marco JA, Alaez C, Perez-Calvo J, Martinez-Sanchez P, Sanchez-Gonzalez B, Canales MA, Conde E, Martin A, Arranz E, Terol MJ, Salar A, Caballero D. First-line treatment with rituximab-hyperCVAD alternating with rituximab-methotrexate-cytarabine and followed by consolidation with 90Y-ibritumomab-tiuxetan in patients with mantle cell lymphoma. Results of a multicenter, phase 2 pilot trial from the GELTAMO group. Haematologica. 2013 Oct;98(10):1563-70. doi: 10.3324/haematol.2013.088377. Epub 2013 Jun 10.

    PubMed 23753021

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing AMG 531 in people with Immune (Idiopathic) Thrombocytopenic Purpura (ITP), run by Kyowa Kirin Co., Ltd. at 13 sites in Japan.

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 3 inclusion and 11 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 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 21 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?

Percentage of Participants With Adverse Events Including Clinically Significant Changes in Laboratory Values. (time frame: Through study completion, the median treatment duration (time between first dose and last dose) was 146.0 weeks (range: 12 to 243 weeks)). 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 NCT00440037, which also lists 1 linked publication.

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 21 Jan 2020.

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