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Summary

for people ages 12–65 (full criteria)
at Oakland, California and other locations
study started
estimated completion:

Description

Summary

A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of GBT440 Administered Orally to Patients With Sickle Cell Disease

Official Title

A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of GBT440 Administered Orally to Patients With Sickle Cell Disease

Details

This is a randomized, placebo-controlled, double blind, parallel group, multicenter study of participants, age 12 to 65 years, with SCD. The key purpose for the study is to establish efficacy and safety of GBT440 as compared with placebo.

Keywords

Sickle Cell Disease Anemia, Sickle Cell

Eligibility

You can join if…

Open to people ages 12–65

  1. Male or female study participants with sickle cell disease
  2. Participants have had at least 1 episode of vaso-occlusive crisis (VOC) in the past 12 months.
  3. Age 12 to 65 years
  4. Hemoglobin (Hb) ≥5.5 and ≤10.5 g/dL during screening
  5. For participants taking hydroxyurea (HU), the dose of HU (mg/kg) must be stable for at least 3 months prior to signing the ICF.

You CAN'T join if...

  1. More than 10 VOCs within the past 12 months that required a hospital, emergency room or clinic visit
  2. Patients who are receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion) or have received a RBC transfusion for any reason within 60 days of signing the ICF
  3. Hospitalized for sickle cell crisis or other vaso-occlusive event within 14 days of signing the ICF (i.e., a vaso-occlusive event cannot be within 14 days prior to signing the ICF)
  4. Hepatic dysfunction characterized by alanine aminotransferase (ALT) >4 × upper limit of normal
  5. Severe renal dysfunction (estimated glomerular filtration rate at the Screening visit;calculated by the central laboratory) <30 mL/min/1.73 m2 or on chronic dialysis

Locations

  • Oakland, California, 94609, United States
  • Las Vegas, Nevada, 89109, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Global Blood Therapeutics
ID
NCT03036813
Phase
Phase 3
Study Type
Interventional
Last Updated
January 3, 2018
I’m interested in this study!