A Study to Assess the Effect of Ticagrelor in Reducing the Number of Days With Pain in Patients With Sickle Cell Disease (Hestia2)

November 27, 2018 updated by: AstraZeneca

A Randomised, Double-blind, Double-dummy, Parallel-group, Multicenter, Phase IIb Study to Evaluate the Effect of Ticagrelor Versus Placebo in Reducing the Number of Days With Pain in Young Adults With Sickle Cell Disease

The purpose of this study is to determine whether ticagrelor is effective in reducing the number of days of pain, intensity of pain, and reducing the use of analgesics due to sickle cell disease

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomised, double-blind, double-dummy, parallel-group, placebo-controlled, study evaluating 2 doses of ticagrelor in 90 patients aged 18 to 30 years, with sickle cell disease (SCD). Patients will be randomised to double-blind double-dummy treatment period in a 1:1:1 ratio (30 to each treatment group) to receive ticagrelor 10 mg twice daily (bid), or ticagrelor 45 mg bid, or placebo bid to determine the frequency of days with pain using an electronic diary (eDiary) every day. Approximately 180 patients will be enrolled. Patient will be followed for safety assessment during and after 2 weeks of treatment completion.

During the 16 week treatment period, patients will complete a daily eDiary concerning daily pain intensity, pain location, use of analgesics and absence from school or work. At the end of the study patients will be asked to rate the change in their sickle cell pain compared to the start of treatment. Platelet aggregation will be measured and reported as P2Y12 reaction units (PRU) pre-dose and 2 hours post-dose at week 4 and week 5 after treatment start. Pharmacokinetic (PK) parameters will be measured at 2 hours post-dose at week 4, and pre-dose and at 2 hours post-dose at week 5. Biomarkers will be assessed pre-dose at week 4, week 5 and week 8. During the study, patients will be evaluated for adverse events (AEs) including bleeding and vaso-occlusive crisis (VOC).

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21131
        • Research Site
      • Cairo, Egypt, 11566
        • Research Site
      • Cairo, Egypt, 11562
        • Research Site
  • France
      • Bordeaux Cedex, France, 33076
        • Research Site
      • Strasbourg, France, 67091
        • Research Site
  • Italy
      • Verona, Italy, 37134
        • Research Site
  • Kenya
      • Kikuyu, Kenya, 00100
        • Research Site
      • Kisian, Kenya, 40100
        • Research Site
      • Nairobi, Kenya, 40100
        • Research Site
  • Lebanon
      • Beirut, Lebanon, 1107 2020
        • Research Site
      • Beirut, Lebanon, 113-6044
        • Research Site
  • Turkey
      • Adana, Turkey, 01130
        • Research Site
      • Mersin, Turkey, 33079
        • Research Site
      • Van, Turkey, 65080
        • Research Site
  • United Kingdom
      • Harrow, United Kingdom, HA1 3UJ
        • Research Site
      • London, United Kingdom, E1 1BB
        • Research Site
      • London, United Kingdom, E9 6SR
        • Research Site
  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Research Site
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed medical history or diagnosis of homozygous sickle cell (HbSS) or sickle beta-zero-thalassaemia (HbS/β0) by HPLC
  • If treated with hydroxyurea, the dose must have been stable for 3 months

Exclusion Criteria:

  • History of transient ischaemic attack or clinically overt cerebrovascular accident
  • Moderate or severe hepatic impairment
  • Treatment with chronic red blood cell transfusion therapy
  • Pre-dominate cause of pain is not sickle cell disease related
  • Chronic treatment with anticoagulants or antiplatelet drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
10 mg ticagrelor placebo + 45 mg ticagrelor placebo. Drugs taken orally, twice a day (morning and evening at least 12 hours apart) from randomization until the end of treatment
Experimental: Dose A
Drug: Ticagrelor
Two arms: 1) 10 mg ticagrelor + 45 mg ticagrelor placebo or 2) 45 mg ticagrelor + 10 mg ticagrelor placebo. Drugs taken orally, twice a day (morning and evening, at least 12 hours apart) from randomization until the end of treatment.
Experimental: Dose B
Drug: Ticagrelor
Two arms: 1) 10 mg ticagrelor + 45 mg ticagrelor placebo or 2) 45 mg ticagrelor + 10 mg ticagrelor placebo. Drugs taken orally, twice a day (morning and evening, at least 12 hours apart) from randomization until the end of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Proportion of Days With Pain Due to Sickle Cell Disease as Measured by an eDiary
Time Frame: Baseline through Week 12
To investigate the efficacy of 2 different doses of ticagrelor versus placebo in reducing the number of days with pain due to sickle cell disease.
Baseline through Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average of the Daily Worst Pain Values Reported Via eDiary
Time Frame: Baseline through Week 12
To determine the efficacy of 2 different doses of ticagrelor versus placebo in reducing the intensity of pain due to sickle cell disease. Intensity of pain was recorded on an 11-point scale where 0 represented no pain and 10 represented the worst pain imaginable.
Baseline through Week 12
Change in Proportion of Days With Analgesic Use Measured by an eDiary
Time Frame: Baseline through Week 12
To assess the efficacy of 2 different doses of ticagrelor versus placebo in reducing the use of analgesics by patients with sickle cell disease.
Baseline through Week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Major Bleeding or Clinically Relevant Non-major Bleeding Events (Patients)
Time Frame: Baseline through Week 12
To assess safety and tolerability of 2 different doses of ticagrelor versus placebo in patients with SCD
Baseline through Week 12
Number of Major Bleeding or Clinically Relevant Non-major Bleeding Events (Events)
Time Frame: Baseline through Week 12
To assess safety and tolerability of 2 different doses of ticagrelor versus placebo in patients with SCD
Baseline through Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Maria Ignacia -Berraondo, MD, Quintiles, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2015

Primary Completion (Actual)

November 16, 2016

Study Completion (Actual)

November 16, 2016

Study Registration Dates

First Submitted

June 17, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (Estimate)

June 26, 2015

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

November 27, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5136C00008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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