Last updated: 11/03/2018 20:37:37

This product has been transferred to Emergent BioSolutions. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.

A Phase 4, Open-label Field Study (200137) to Evaluate the Clinical Benefit, Safety and Pharmacokinetics in Subjects treated with Raxibacumab (GSK3068483) Following Exposure to Bacillus anthracis

GSK study ID

200137

Clinicaltrials.gov ID

NCT02177721

EudraCT ID

Not applicable

EU CT Number

Not applicable

Trial status

No longer a GSK study

Overview

Eligibility

Locations

Study documents

Results summary

Plain language summaries

Additional information

Trial overview

Official title: A Phase 4, Open-label Field Study (200137) to Evaluate the Clinical Benefit, Safety and Pharmacokinetics in Subjects treated with Raxibacumab (GSK3068483) Following Exposure to Bacillus anthracis

Trial description: This field study is designed such that it may be implemented for any individual who has been administered raxibacumab for treatment of anthrax or for post exposure prophylaxis including sporadic cases, small anthrax incidents and/or a mass event. This study is designed to describe the clinical effectiveness (including course of illness and survival), safety profile, and raxibacumab pharmacokinetics (PK) from patients who are treated with raxibacumab as part of their clinical care following exposure to B. anthracis. Study data and samples for PK and other investigational research will be collected prospectively to the extent possible at pre-specified time points. However, because of the logistical complexities that would likely accompany a mass anthrax event, most data in this study is anticipated to be collected retrospectively. During such a mass anthrax event scavenged blood samples will be utilized where possible to maximize sample analyses for PK and other investigational parameters. Therefore, both retrospective and prospective data collection are allowed in this protocol in order to maximize the amount of information obtained in subjects who have been administered raxibacumab. This field study will be the first opportunity to collect data on B. anthracis-exposed patients treated with raxibacumab, to better understand the clinical benefit and safety of the drug and to further inform patient care and treatment choices for management of anthrax

Primary purpose:

Treatment

Trial design:

Single Group Assignment

Masking:

None (Open Label)

Allocation:

Not applicable

Primary outcomes:

Assessment of clinical benefit by overall survival for cohort 1

Timeframe: Up to Week 24

Assessment of clinical benefit by emergence rate of systemic anthrax infection for Cohort 2

Timeframe: Up to Week 24

Assessment of clinical benefit by rate of resolution of edema and healing of lesion without emergence of systemic anthrax infection for cohort 3

Timeframe: Up to Week 24

Secondary outcomes:

Survival rate on Day 14 and Day 28

Timeframe: Up to Day 28

Length of (Intensive Care Unit) ICU stay

Timeframe: Up to Week 24

Incidence of associated complication of anthrax (meningitis, pleural effusion)

Timeframe: Up to Day 28

Incidence of the progression of the disease clinical stage for subject in Cohort 1

Timeframe: Up to Week 24

Incidence of the progression to systemic anthrax infection for subjects in Cohorts 2 and 3

Timeframe: Up to Week 24

Summary of the area of wound/lesions for subjects in Cohort 3

Timeframe: Up to Week 24

Summary of significant concurrent medical treatment

Timeframe: Up to Week 24

Summary of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: Up to Week 24

Summary of ECG data

Timeframe: Up to Week 24

Summary of Vital Signs

Timeframe: Up to Week 24

Summary of serum raxibacumab concentrations

Timeframe: Up to Week 24

Summary of disease markers: Protective Antigen (PA), toxin neutralizing antibody (TNA) and Anti-drug antibody (ADA) levels

Timeframe: Up to Week 24

Length of hospital stay

Timeframe: Up to Week 24

Summary of neurological function as assessed by Glasgow Coma Scale or Adelaide Pediatric Scale

Timeframe: Up to 24 weeks

Summary of daily functionality as assessed by Katz ADL

Timeframe: Up to 24 weeks

Incidence of bacteremia

Timeframe: Up to 24 weeks

Summary of clinical chemistry and hematology laboratory data

Timeframe: Up to 24 weeks

Interventions:

Vaccine: Collection of samples

Enrollment:

100

Primary completion date:

2021-01-04

Observational study model:

Not applicable

Time perspective:

Not applicable

Clinical publications:

Not applicable

Medical condition

Infections, Bacterial

Product

raxibacumab

Collaborators

Centers for Disease Control and Prevention, Biomedical Advanced Research and Development Authority-BARDA

Study date(s)

September 2018 to April 2021

Type

Interventional

Phase

Participation criteria

Sex

Female & Male

Age

Not applicable

Accepts healthy volunteers

None

Women-including pregnant and lactating women, men, and children of all ages who receive treatment with raxibacumab as part of their clinical care for anthrax infection or for post-exposure prophylaxis will be eligible to enroll in this study.
Subjects willing and able to adhere to the procedures stated in the protocol

There are no exclusion criteria for subjects enrolling in this study.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status

No longer a GSK study

Actual primary completion date

Not applicable

Actual study completion date

Not applicable

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information

Not applicable

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Access to clinical trial data by researchers

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