NCT01352585

Brief Summary

This study is hypothesis-generating to explore the impact of JAK2 (V617F) mutation status on the treatment response to anagrelide hydrochloride

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2011

Typical duration for all trials

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

July 19, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2013

Completed
10 months until next milestone

Results Posted

Study results publicly available

July 29, 2014

Completed
Last Updated

July 30, 2021

Status Verified

July 1, 2021

Enrollment Period

2.2 years

First QC Date

May 10, 2011

Results QC Date

June 27, 2014

Last Update Submit

July 6, 2021

Conditions

Essential Thrombocythemia (ET)

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Platelet Count ≤600x10^9/L After 12 Months

    A platelet count of ≤600x10\^9/L after 12 months is considered at least a partial response.

    1 year

Secondary Outcomes (8)

  • Number of Patients With Platelet Count ≤400x10^9/L After 12 Months

    1 year

  • Platelet Count

    1 year

  • Red Blood Cell (RBC) Count

    1 year

  • White Blood Cell (WBC) Count

    1 year

  • Differential WBC Count - Neutrophils, Lymphocytes, Monocytes, and Basophils.

    1 year

  • +3 more secondary outcomes

Study Arms (2)

JAK2 Positive Participants

Drug: Anagrelide hydrochloride

JAK2 Negative Participants

Drug: Anagrelide hydrochloride

Interventions

Anagrelide hydrochlorideDRUG

0.5 mg hard capsules, dosing decisions will be made by the treating physician

Also known as: Xagrid
JAK2 Negative ParticipantsJAK2 Positive Participants

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ET patients in Italy

You may qualify if:

  • Patients must be able to understand and willing to participate in the study, and provide a personally dated and signed written informed consent form.
  • Patients must have a confirmed diagnosis of ET according to the World health Organisation's criteria.
  • ET patients who are uncontrolled, in the Investigator's opinion, by first-line (or previous) cytoreductive treatment for efficacy or tolerance reasons.
  • Patients who have either commenced treatment with anagrelide hydrochloride in the last 7 days or for whom a decision has been documented to commence treatment with anagrelide hydrochloride

You may not qualify if:

  • Patients for whom treatment with anagrelide hydrochloride is contraindicated, according to the current XAGRID SmPC.
  • Known or suspected intolerance or hypersensitivity to the product, closely related compounds, or any of the stated ingredients.
  • Patients participating in an interventional research study.
  • Patients on combination therapy or for whom there is an intention to treat with other cytoreductive agents e.g., hydroxyurea, interferon. Patients can however use aspirin and other anti-aggregatory products at the Investigator's discretion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Azienda Ospedaliera Policlinico di Bari

Bari, Italy

Location

Istituto Seragnoli-Policlinico S.Orsola-Malpighi

Bologna, Italy

Location

A.O. Spedali Civili di Brescia

Brescia, Italy

Location

Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

Location

Ospedale San Martino

Genova, Italy

Location

Fondazione IRCCS Ca' Granda

Milan, 20125, Italy

Location

Azienda Ospedaliera Universitaria "Federico II"

Napoli, 80131, Italy

Location

Ospedale Maggiore della Carita

Novara, Italy

Location

Policlinico A. Gemelli

Roma, Italy

Location

Padiglione ex-oncologico Ospedale S.Maria

Terni, Italy

Location

Related Publications (1)

  • Cascavilla N, De Stefano V, Pane F, Pancrazzi A, Iurlo A, Gobbi M, Palandri F, Specchia G, Liberati AM, D'Adda M, Gaidano G, Fjerza R, Achenbach H, Smith J, Wilde P, Vannucchi AM. Impact of JAK2(V617F) mutation status on treatment response to anagrelide in essential thrombocythemia: an observational, hypothesis-generating study. Drug Des Devel Ther. 2015 May 18;9:2687-94. doi: 10.2147/DDDT.S79576. eCollection 2015.

    PMID: 26028965RESULT

MeSH Terms

Conditions

Thrombocythemia, Essential

Interventions

anagrelide

Condition Hierarchy (Ancestors)

Blood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombocytosisBlood Platelet DisordersMyeloproliferative DisordersBone Marrow DiseasesHemorrhagic Disorders

Results Point of Contact

Title
Study Director
Organization
Shire
ClinicalTransparency@shire.com
+1 866 842 5335

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2011

First Posted

May 12, 2011

Study Start

July 19, 2011

Primary Completion

September 19, 2013

Study Completion

September 19, 2013

Last Updated

July 30, 2021

Results First Posted

July 29, 2014

Record last verified: 2021-07

Locations

IT(10)