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Trial · NCT02285088

A Study of the Safety, Blood Levels and Biological Effects of GBT440 in Healthy Subjects and Subjects With Sickle Cell Disease

NCT02285088, Phase 1, Completed, Global Blood Therapeutics

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study of the Safety, Blood Levels and Biological Effects of GBT440 in Healthy Subjects and Subjects With Sickle Cell Disease. Trials, record NCT02285088. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02285088

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A Study of the Safety, Blood Levels and Biological Effects of GBT440 in Healthy Subjects and Subjects With Sickle Cell Disease
NCT number
NCT02285088
Status
Completed
Phases
Phase 1
Enrollment
133 participants, actual
Lead sponsor
Global Blood Therapeutics
Conditions
Healthy Subjects, Sickle Cell Disease
Interventions
GBT440, Placebo
First posted
2014-11-06
Last updated
2018-02-15
Other registries' IDs
eudract:2014-003555-62

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimarySafety, as assessed by frequency and severity of adverse events (AEs), and changes in vital signs, 12-lead electrocardiograms (ECGs), and laboratory assessments as compared to baseline30 - 118 days
SecondaryBlood and plasma area under the concentration time curve (AUC) of GBT44030 - 118 days
SecondaryBlood and plasma maximum concentration (Cmax) of GBT44030 - 118 days
SecondaryBlood and plasma time to maximum concentration (Tmax) of GBT44030 - 118 days
SecondaryPercentage of hemoglobin occupied or modified by GBT44030 days
SecondaryChange from baseline in heart rate and pulse oximetry following exercise testing in healthy volunteers30 days
OtherPercentage of sickled cells under ex vivo conditions30 - 90 days
OtherEffect of GBT440 on hemolysis as measured by LDH, direct bilirubin, hemoglobin, and reticulocyte count30 - 118 days
OtherChange from baseline in pain as measured by visual analog scale30 days
OtherChange from baseline in fatigue as measured by questionnaire30 - 118 days

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
30655275DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02285088

GET https://conductscience.org/api/trials/v1/NCT02285088/registered