Trial record 1 of 1 for:
NCT03557281
An Early Bactericidal Activity, Safety and Tolerability of GSK3036656 in Subjects With Drug-sensitive Pulmonary Tuberculosis
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ClinicalTrials.gov Identifier: NCT03557281 |
Recruitment Status :
Completed
First Posted : June 15, 2018
Results First Posted : October 26, 2023
Last Update Posted : October 26, 2023
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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: Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Tuberculosis |
Interventions |
Drug: GSK3036656 Drug: Rifafour e-275 |
Enrollment | 76 |
Participant Flow
Recruitment Details | This was an open-label trial to investigate the early bactericidal activity, safety and tolerability of GSK3036656 in participants with drug-sensitive pulmonary tuberculosis. Participants received Rifafour e-275 as a standard-of-care or GSK3036656. Rifafour e-275 is a registered trademark of Sanofi-Aventis company. |
Pre-assignment Details | A total of 76 participants were enrolled (Enrolled Population consisted of all participants who passed screening and entered the study) in this study. |
Arm/Group Title | Rifafour e-275 | GSK3036656 1 mg | GSK3036656 5 mg | GSK3036656 15 mg | GSK3036656 30 mg |
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Arm/Group Description | All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed. | Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14. | Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14. | Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14. | Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14. |
Period Title: Overall Study | |||||
Started | 18 | 9 | 17 | 16 | 16 |
Safety Population Consisted of All Randomized Participants Who Received at Least 1 Dose of Treatment | 18 | 9 | 17 | 16 | 15 |
Completed | 18 | 8 | 15 | 15 | 13 |
Not Completed | 0 | 1 | 2 | 1 | 3 |
Reason Not Completed | |||||
Investigator discretion | 0 | 0 | 1 | 0 | 0 |
Withdrawal by Subject | 0 | 1 | 1 | 1 | 2 |
Randomized, but did not receive treatment | 0 | 0 | 0 | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Rifafour e-275 | GSK3036656 1 mg | GSK3036656 5 mg | GSK3036656 15 mg | GSK3036656 30 mg | Total | |
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Arm/Group Description | All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed. | Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14. | Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14. | Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14. | Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14. | Total of all reporting groups | |
Overall Number of Baseline Participants | 18 | 9 | 17 | 16 | 15 | 75 | |
Baseline Analysis Population Description |
Safety Population consisted of all randomized participants who received at least one dose of study treatment.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 18 participants | 9 participants | 17 participants | 16 participants | 15 participants | 75 participants | |
37.0 (10.20) | 37.8 (8.38) | 38.1 (10.33) | 39.8 (12.33) | 38.5 (9.82) | 38.2 (10.22) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | 9 participants | 17 participants | 16 participants | 15 participants | 75 participants | |
Female |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Male |
18 100.0%
|
9 100.0%
|
17 100.0%
|
16 100.0%
|
15 100.0%
|
75 100.0%
|
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | 9 participants | 17 participants | 16 participants | 15 participants | 75 participants | |
Black or African American |
18 100.0%
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9 100.0%
|
17 100.0%
|
16 100.0%
|
15 100.0%
|
75 100.0%
|
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT03557281 |
Other Study ID Numbers: |
201214 |
First Submitted: | June 4, 2018 |
First Posted: | June 15, 2018 |
Results First Submitted: | November 17, 2022 |
Results First Posted: | October 26, 2023 |
Last Update Posted: | October 26, 2023 |