Trial record 2 of 3 for:
GSK2586881
A Dose-escalation Study in Subjects With Pulmonary Arterial Hypertension (PAH)
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ClinicalTrials.gov Identifier: NCT03177603 |
Recruitment Status :
Completed
First Posted : June 6, 2017
Results First Posted : April 21, 2020
Last Update Posted : April 21, 2020
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Hypertension, Pulmonary |
Intervention |
Drug: GSK2586881 |
Enrollment | 23 |
Participant Flow
Recruitment Details | This phase 2a, open-label, dose-escalation study comprised of 4 cohorts. Participants received GSK2586881 by single intravenous (IV) infusion at following doses: 0.1 milligram per kilogram (mg/kg) or 0.2 mg/kg or 0.4 mg/kg or 0.8 mg/kg. |
Pre-assignment Details | A total of 31 participants were screened and of them 7 participants were screen failures and one withdrew consent before dosing. Hence, a total of 23 participants received study treatment. This study was conducted at 4 centers in Germany, 2 centers in Spain, and 2 centers in the United States. |
Arm/Group Title | GSK2586881 0.1 mg/kg | GSK2586881 0.2 mg/kg | GSK2586881 0.4 mg/kg | GSK2586881 0.8 mg/kg |
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Participants received a single IV dose of 0.1 mg/kg GSK2586881 and were followed up till 28 days post-dose. | Participants received a single IV dose of 0.2 mg/kg GSK2586881 and were followed up till 28 days post-dose. | Participants received a single IV dose of 0.4 mg/kg GSK2586881 and were followed up till 28 days post-dose. | Participants received a single IV dose of 0.8 mg/kg GSK2586881 and were followed up till 28 days post-dose. |
Period Title: Cohort 1: Dose Level 0.1 mg/kg (28 Days) | ||||
Started | 4 | 0 | 0 | 0 |
Completed | 4 | 0 | 0 | 0 |
Not Completed | 0 | 0 | 0 | 0 |
Period Title: Cohort 2: Dose Level 0.2 mg/kg (28 Days) | ||||
Started | 0 | 5 | 0 | 0 |
Completed | 0 | 5 | 0 | 0 |
Not Completed | 0 | 0 | 0 | 0 |
Period Title: Cohort 3: Dose Level 0.4 mg/kg (28 Days) | ||||
Started | 0 | 0 | 6 | 0 |
Completed | 0 | 0 | 6 | 0 |
Not Completed | 0 | 0 | 0 | 0 |
Period Title: Cohort 4: Dose Level 0.8 mg/kg (28 Days) | ||||
Started | 0 | 0 | 0 | 8 |
Completed | 0 | 0 | 0 | 8 |
Not Completed | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | GSK2586881 0.1 mg/kg | GSK2586881 0.2 mg/kg | GSK2586881 0.4 mg/kg | GSK2586881 0.8 mg/kg | Total | |
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Participants received a single IV dose of 0.1 mg/kg GSK2586881 and were followed up till 28 days post-dose. | Participants received a single IV dose of 0.2 mg/kg GSK2586881 and were followed up till 28 days post-dose. | Participants received a single IV dose of 0.4 mg/kg GSK2586881 and were followed up till 28 days post-dose. | Participants received a single IV dose of 0.8 mg/kg GSK2586881 and were followed up till 28 days post-dose. | Total of all reporting groups | |
Overall Number of Baseline Participants | 4 | 5 | 6 | 8 | 23 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 4 participants | 5 participants | 6 participants | 8 participants | 23 participants | |
32.0 (4.97) | 55.4 (14.96) | 52.5 (8.67) | 50.3 (13.35) | 48.8 (13.55) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 4 participants | 5 participants | 6 participants | 8 participants | 23 participants | |
Female |
3 75.0%
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3 60.0%
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4 66.7%
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5 62.5%
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15 65.2%
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Male |
1 25.0%
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2 40.0%
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2 33.3%
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3 37.5%
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8 34.8%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 4 participants | 5 participants | 6 participants | 8 participants | 23 participants | |
Black or African American |
0 0.0%
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1 20.0%
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1 16.7%
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1 12.5%
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3 13.0%
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White - White/Caucasian/European Heritage |
4 100.0%
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4 80.0%
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5 83.3%
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7 87.5%
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20 87.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: | GSK Response Center |
Organization: | GlaxoSmithKline |
Phone: | 866-435-7343 |
EMail: | GSKClinicalSupportHD@gsk.com |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT03177603 |
Other Study ID Numbers: |
206246 2017-000212-41 ( EudraCT Number ) |
First Submitted: | May 23, 2017 |
First Posted: | June 6, 2017 |
Results First Submitted: | April 6, 2020 |
Results First Posted: | April 21, 2020 |
Last Update Posted: | April 21, 2020 |