Back to resultsA Phase 2/3 Study of GLASSIA for the Treatment of Acute GvHD
Primary Purpose
Graft Versus Host Disease
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GLASSIA
methylprednisolone or equivalent steroid
Albumin
Sponsored by
About this trial
This is an interventional treatment trial for Graft Versus Host Disease
Eligibility Criteria
Inclusion Criteria:
- Male or female participants aged ≥18 years at the time of screening
- Recipient of an hematopoietic stem cell transplantation (HSCT)
- The disease indication for which the participant required HSCT must be in remission
- Newly diagnosed acute graft-versus-host disease (GvHD), including lower Gastrointestinal (GI) involvement (modified International Bone Marrow Transplant Registry [IBMTR] Severity Stage 1 to 4 [>500 mL diarrhea/day]), with or without other organ system involvement.
- Willing to undergo or must have had a lower GI biopsy within 7 days of informed consent to confirm GI GvHD. Biopsy results are not needed to initiate treatment; however, if biopsy results are not consistent with aGvHD, treatment with GLASSIA will be discontinued.
- Participants must be receiving systemic corticosteroids. Treatment with methylprednisolone/systemic steroids must have been initiated within 72 hours prior to the first dose of study treatment after enrollment
- Evidence of myeloid engraftment (absolute neutrophil count ≥0.5 x 10^9/L)
- Lower GI GvHD manifested by diarrhea must have other causes of diarrhea ruled out (eg, negative for Clostridium difficile or cytomegalovirus [CMV] infection or oral magnesium administration)
- Karnofsky Performance Score ≥50%
- If female of childbearing potential, participant presents with a negative blood pregnancy test
- Females of childbearing potential with a fertile male sexual partner must agree to employ adequate contraception for the duration of the study.
- Males must use adequate contraception and must not donate sperm for the duration of the study.
- Participant is willing and able to comply with the requirements of the protocol
Exclusion Criteria:
- Participant with manifestations of chronic GvHD
- Participant with acute/chronic GvHD overlap syndrome
- Participant whose GvHD developed after donor lymphocyte infusion
- Participant with myocardial infarction within 6 months prior to enrollment or New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to the first dose of study treatment, any electrocardiogram (ECG) abnormality at screening must be documented by the investigator as not medically relevant
- Participant with evidence of recurrent malignancy
- Participant with veno-occlusive disease (ie, sinusoidal obstruction syndrome)
- Participant receiving GvHD treatment other than continued prophylaxis (eg, cyclosporine and/or mycophenolate mofetil, etc) or corticosteroid therapy. In addition, a participant who received the first dose of corticosteroid therapy for acute GvHD with lower GI involvement more than 72 hours before the first dose of study treatment is not eligible for the study
- Participant with severe sepsis involving at least 1 organ failure
- Participant who is seropositive or positive in the nucleic acid test for human immunodeficiency virus (HIV)
- Participant with active hepatitis B or C
- Participant has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
- If female, participant is pregnant or lactating at the time of enrollment, or has plans to become pregnant during the study
- Participant with a serious medical or psychiatric illness likely to interfere with participation in the study
- Participant is a family member or employee of the investigator
Sites / Locations
- Georgia Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Study Part 1 - All Participants - GLASSIA
Study Part 2 - GLASSIA
Study Part 2 - Albumin (Control)
Arm Description
Participants to receive GLASSIA (intravenously) and methylprednisolone or equivalent steroid (either IV or oral per investigator discretion)
Participants to receive GLASSIA (intravenously) and methylprednisolone or equivalent steroid (either IV or oral per investigator discretion)
Participants to receive control (intravenously) and methylprednisolone or equivalent steroid (either IV or oral per investigator discretion)
Outcomes
Primary Outcome Measures
Percentage of Participants Achieving Overall Response (OR) At Day 28
OR was defined as graft-versus-host disease (GvHD) complete response (CR) + partial response (PR), defined as: - GvHD CR was complete resolution of all signs and symptoms of acute GvHD in all organs without intervening salvage and GvHD PR was improvement of 1 stage in 1 or more organs involved in GvHD without progression in other organs.
Secondary Outcome Measures
Percentage of Participants Achieving Gastrointestinal (GI) Response at Day 28
GI response was defined as complete response (CR) + partial response (PR), defined as: - GI CR was able to eat; not requiring parenteral nutrition, and passing primarily formed stools - GI PR was decrease in need for parenteral nutrition to less than or equal to (<=) 50% of required calories; and reduction of stool volume by greater than or equal to (>=) 50%, without ileus.
Percentage of Participants Achieving Overall Response at Day 56
Overall response was defined as graft-versus-host disease (GvHD) complete response (CR) + partial response (PR), defined as: - GvHD CR was complete resolution of all signs and symptoms of acute GvHD in all organs without intervening salvage - GvHD PR was improvement of 1 stage in 1 or more organs involved in GvHD without progression in other organs.
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Grading of GvHD was performed by the investigator according to the modified International Bone Marrow Transplant Registry (IBMTR) grading system which classifies the degree of involvement of each organ system by stage on a scale of 0 to 4. The degree of skin involvement was staged depending upon degree and severity of the lesions: Stage 1: Maculopapular rash over less than (<) 25% of body area, Stage 2: Maculopapular rash over 25 to 50% of body area, Stage 3: Generalized erythroderma, Stage 4: Generalized erythroderma with bullous formation. Degree of GI involvement was staged based on severity of diarrhoea: Stage 1: 500 to 1000 mL/day,Stage 2: 1000 to 1500 mL/day, Stage 3: 1500 to 2000 mL/day, Stage 4: greater than (>) 2000 mL/day OR pain OR ileus. Degree of liver involvement was staged based upon serum total bilirubin level as follows: Stage 1: 2 to 3 mg/dL, Stage 2: 3 to 6 mg/dL, Stage 3: 6 to 15 mg/dL, Stage 4: >15 mg/dL.
Incidence of Chronic Graft-versus-host Disease (GvHD)
Incidence of chronic GvHD at Days 180 and 365 was reported.
Duration of Overall Response (OR)
OR was defined as GvHD CR + PR, defined as: - GvHD CR was complete resolution of all signs and symptoms of acute GvHD in all organs without intervening salvage - GvHD PR was improvement of 1 stage in 1 or more organs involved in GvHD without progression in other organs. Duration of OR was not assessed due to the termination of the study.
Duration of Gastrointestinal (GI) Response
GI response was defined as CR + PR, defined as: - GI CR was able to eat; not requiring parenteral nutrition, and passing primarily formed stools - GI PR was decrease in need for parenteral nutrition to <= 50% of required calories; and reduction of stool volume by >= 50%, without ileus. Duration of GI response was not assessed due to the termination of the study.
Overall Survival (OS) - Percentage of Participants With an Event
OS was defined as the time from the date of randomization to the date of death due to any cause.
Transplant-related Mortality
Transplant-related mortality was determined by the investigator (any deaths considered related to the transplant).
Failure-free Survival - Percentage of Participants With an Event
Failure-free survival was defined as the absence of all of the following criteria: Need for second-line treatment for acute GvHD, Non-relapse mortality (death during continuous complete remission) and recurrent malignancy.
Graft-versus-host Disease (GvHD)-Free Survival - Percentage of Participants With an Event
GVHD-free survival was defined as being alive without previous onset of acute GVHD or chronic GVHD requiring immunosuppressive therapy.
Infection-related Mortality - Percentage of Participants With an Event
Infection-related mortality was determined by the investigator (any deaths considered related to infection [including infections related to hematopoietic stem cell transplant {HSCT}]).
Graft-versus-host Disease (GvHD)-Related Mortality - Percentage of Participants With an Event
Graft-versus-host disease (GvHD)-related mortality was determined by the investigator (any deaths considered related to GvHD).
All-cause Mortality - Percentage of Participants With an Event
All-cause mortality was defined as the time from HSCT to death due to any cause.
Number of Participants With Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs and Temporally-associated AEs
An AE was defined as any untoward medical occurrence in a participant administered an investigational product (IP) that does not necessarily have a causal relationship with the treatment. An SAE was defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome was fatal/results in death, life-threatening, required inpatient hospitalization or resulted in prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
Clinical laboratory assessments such as hematology, clinical chemistry, lipid and coagulation panels and urinalysis were performed.
Number of Participants With Clinically Significant Changes in Vital Signs
Vital signs included body temperature, respiratory rate, pulse rate and systolic and diastolic blood pressure.
Number of Participants With Recurrence of Primary Malignancies
Incidence of recurrence of primary malignancies was reported.
Area Under the Plasma Concentration Curve (AUC0-inf) From Time Zero to Infinity
AUC of GLASSIA was reported.
Area Under the Plasma Concentration Curve From Time Zero to Time "t" AUC(0-t) of GLASSIA
AUC(0-t) of GLASSIA was reported.
Systemic Clearance at Steady State (CLss) of GLASSIA
CLss of GLASSIA was reported.
Maximum Observed Plasma Concentration (Cmax) of GLASSIA
Cmax of GLASSIA was reported.
Apparent Volume of Distribution at Steady State (Vss) of GLASSIA
Vss of GLASSIA was reported.
Apparent Terminal Half-life (t1/2) of GLASSIA
Apparent terminal half-life (hour), determined as ln2/lambda-z. lambda-z is the apparent terminal rate constant (one per hour), determined by linear regression of the terminal points of the log-linear concentration-time curve. Visual assessment will be used to identify the terminal linear phase of the concentration-time profile. A minimum of 3 data points will be used for determination. t1/2 of GLASSIA was reported.
Mean Residence Time (MRT) of GLASSIA
MRT of GLASSIA was not calculated.
Trough Plasma Concentration at Steady State (Ctrough) of GLASSIA
Ctrough of GLASSIA was not assessed due to the termination of the study.
Full Information
NCT ID
NCT02956122
First Posted
October 24, 2016
Last Updated
December 22, 2020
Sponsor
Baxalta now part of Shire
Collaborators
Kamada, Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02956122
Brief Title
A Phase 2/3 Study of GLASSIA for the Treatment of Acute GvHD
Official Title
A Two-Part, Multi-Center, Prospective, Phase 2/3 Clinical Study to Evaluate the Safety and Efficacy of GLASSIA as an Add-On Biopharmacotherapy to Conventional Steroid Treatment in Subjects With Acute Graft-Versus-Host Disease With Lower Gastrointestinal Involvement
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
The decision to discontinue the study was based on business reasons.
Study Start Date
April 26, 2017 (Actual)
Primary Completion Date
May 3, 2018 (Actual)
Study Completion Date
May 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxalta now part of Shire
Collaborators
Kamada, Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to evaluate the safety and efficacy of GLASSIA as an add-on biopharmacotherapy to standard-of-care steroid treatment as the first-line treatment in participants with acute GvHD with lower GI involvement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Versus Host Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Part 1 - All Participants - GLASSIA
Arm Type
Experimental
Arm Description
Participants to receive GLASSIA (intravenously) and methylprednisolone or equivalent steroid (either IV or oral per investigator discretion)
Arm Title
Study Part 2 - GLASSIA
Arm Type
Experimental
Arm Description
Participants to receive GLASSIA (intravenously) and methylprednisolone or equivalent steroid (either IV or oral per investigator discretion)
Arm Title
Study Part 2 - Albumin (Control)
Arm Type
Placebo Comparator
Arm Description
Participants to receive control (intravenously) and methylprednisolone or equivalent steroid (either IV or oral per investigator discretion)
Intervention Type
Biological
Intervention Name(s)
GLASSIA
Other Intervention Name(s)
as alpha-1 antitrypsin, A1PI, alpha-1 proteinase inhibitor
Intervention Description
GLASSIA [Alpha1-Proteinase Inhibitor (Human)]
Intervention Type
Drug
Intervention Name(s)
methylprednisolone or equivalent steroid
Intervention Description
The conventional steroid treatment (methylprednisolone or equivalent steroid) will be supplied by the investigators per their institutional practice.
Intervention Type
Biological
Intervention Name(s)
Albumin
Other Intervention Name(s)
Human Albumin
Intervention Description
The control vials contain human albumin 20% in 50 mL normal saline solution in glass vials (for non-United States (US) Countries), or Flexbumin 25% in 50 mL in normal saline solution in plastic IV bags (for US).
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Overall Response (OR) At Day 28
Description
OR was defined as graft-versus-host disease (GvHD) complete response (CR) + partial response (PR), defined as: - GvHD CR was complete resolution of all signs and symptoms of acute GvHD in all organs without intervening salvage and GvHD PR was improvement of 1 stage in 1 or more organs involved in GvHD without progression in other organs.
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Gastrointestinal (GI) Response at Day 28
Description
GI response was defined as complete response (CR) + partial response (PR), defined as: - GI CR was able to eat; not requiring parenteral nutrition, and passing primarily formed stools - GI PR was decrease in need for parenteral nutrition to less than or equal to (<=) 50% of required calories; and reduction of stool volume by greater than or equal to (>=) 50%, without ileus.
Time Frame
Day 28
Title
Percentage of Participants Achieving Overall Response at Day 56
Description
Overall response was defined as graft-versus-host disease (GvHD) complete response (CR) + partial response (PR), defined as: - GvHD CR was complete resolution of all signs and symptoms of acute GvHD in all organs without intervening salvage - GvHD PR was improvement of 1 stage in 1 or more organs involved in GvHD without progression in other organs.
Time Frame
Day 56
Title
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Description
Grading of GvHD was performed by the investigator according to the modified International Bone Marrow Transplant Registry (IBMTR) grading system which classifies the degree of involvement of each organ system by stage on a scale of 0 to 4. The degree of skin involvement was staged depending upon degree and severity of the lesions: Stage 1: Maculopapular rash over less than (<) 25% of body area, Stage 2: Maculopapular rash over 25 to 50% of body area, Stage 3: Generalized erythroderma, Stage 4: Generalized erythroderma with bullous formation. Degree of GI involvement was staged based on severity of diarrhoea: Stage 1: 500 to 1000 mL/day,Stage 2: 1000 to 1500 mL/day, Stage 3: 1500 to 2000 mL/day, Stage 4: greater than (>) 2000 mL/day OR pain OR ileus. Degree of liver involvement was staged based upon serum total bilirubin level as follows: Stage 1: 2 to 3 mg/dL, Stage 2: 3 to 6 mg/dL, Stage 3: 6 to 15 mg/dL, Stage 4: >15 mg/dL.
Time Frame
Days 28, 56 and 180
Title
Incidence of Chronic Graft-versus-host Disease (GvHD)
Description
Incidence of chronic GvHD at Days 180 and 365 was reported.
Time Frame
Days 180 and 365
Title
Duration of Overall Response (OR)
Description
OR was defined as GvHD CR + PR, defined as: - GvHD CR was complete resolution of all signs and symptoms of acute GvHD in all organs without intervening salvage - GvHD PR was improvement of 1 stage in 1 or more organs involved in GvHD without progression in other organs. Duration of OR was not assessed due to the termination of the study.
Time Frame
Baseline up to Day 365
Title
Duration of Gastrointestinal (GI) Response
Description
GI response was defined as CR + PR, defined as: - GI CR was able to eat; not requiring parenteral nutrition, and passing primarily formed stools - GI PR was decrease in need for parenteral nutrition to <= 50% of required calories; and reduction of stool volume by >= 50%, without ileus. Duration of GI response was not assessed due to the termination of the study.
Time Frame
Baseline up to Day 365
Title
Overall Survival (OS) - Percentage of Participants With an Event
Description
OS was defined as the time from the date of randomization to the date of death due to any cause.
Time Frame
Days 100, 180 and 365
Title
Transplant-related Mortality
Description
Transplant-related mortality was determined by the investigator (any deaths considered related to the transplant).
Time Frame
Days 28, 56, 100 and 180
Title
Failure-free Survival - Percentage of Participants With an Event
Description
Failure-free survival was defined as the absence of all of the following criteria: Need for second-line treatment for acute GvHD, Non-relapse mortality (death during continuous complete remission) and recurrent malignancy.
Time Frame
Days 100 and 180
Title
Graft-versus-host Disease (GvHD)-Free Survival - Percentage of Participants With an Event
Description
GVHD-free survival was defined as being alive without previous onset of acute GVHD or chronic GVHD requiring immunosuppressive therapy.
Time Frame
Days 28, 56, 100, 180 and 365
Title
Infection-related Mortality - Percentage of Participants With an Event
Description
Infection-related mortality was determined by the investigator (any deaths considered related to infection [including infections related to hematopoietic stem cell transplant {HSCT}]).
Time Frame
Days 28, 56, 100 and 180
Title
Graft-versus-host Disease (GvHD)-Related Mortality - Percentage of Participants With an Event
Description
Graft-versus-host disease (GvHD)-related mortality was determined by the investigator (any deaths considered related to GvHD).
Time Frame
Days 28, 56, 100 and 180
Title
All-cause Mortality - Percentage of Participants With an Event
Description
All-cause mortality was defined as the time from HSCT to death due to any cause.
Time Frame
Days 28, 56, 100 and 180
Title
Number of Participants With Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs and Temporally-associated AEs
Description
An AE was defined as any untoward medical occurrence in a participant administered an investigational product (IP) that does not necessarily have a causal relationship with the treatment. An SAE was defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome was fatal/results in death, life-threatening, required inpatient hospitalization or resulted in prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.
Time Frame
From start of study drug administration up to 371 days
Title
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
Description
Clinical laboratory assessments such as hematology, clinical chemistry, lipid and coagulation panels and urinalysis were performed.
Time Frame
Baseline up to Day 56
Title
Number of Participants With Clinically Significant Changes in Vital Signs
Description
Vital signs included body temperature, respiratory rate, pulse rate and systolic and diastolic blood pressure.
Time Frame
Baseline up to Day 56
Title
Number of Participants With Recurrence of Primary Malignancies
Description
Incidence of recurrence of primary malignancies was reported.
Time Frame
Baseline up to Day 365
Title
Area Under the Plasma Concentration Curve (AUC0-inf) From Time Zero to Infinity
Description
AUC of GLASSIA was reported.
Time Frame
Day 1: through 48 hours; Day 13: through 48 hours; Day 22 and Day 50: through approximately 168 hours
Title
Area Under the Plasma Concentration Curve From Time Zero to Time "t" AUC(0-t) of GLASSIA
Description
AUC(0-t) of GLASSIA was reported.
Time Frame
Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours
Title
Systemic Clearance at Steady State (CLss) of GLASSIA
Description
CLss of GLASSIA was reported.
Time Frame
Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours
Title
Maximum Observed Plasma Concentration (Cmax) of GLASSIA
Description
Cmax of GLASSIA was reported.
Time Frame
Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours
Title
Apparent Volume of Distribution at Steady State (Vss) of GLASSIA
Description
Vss of GLASSIA was reported.
Time Frame
Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours
Title
Apparent Terminal Half-life (t1/2) of GLASSIA
Description
Apparent terminal half-life (hour), determined as ln2/lambda-z. lambda-z is the apparent terminal rate constant (one per hour), determined by linear regression of the terminal points of the log-linear concentration-time curve. Visual assessment will be used to identify the terminal linear phase of the concentration-time profile. A minimum of 3 data points will be used for determination. t1/2 of GLASSIA was reported.
Time Frame
Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours
Title
Mean Residence Time (MRT) of GLASSIA
Description
MRT of GLASSIA was not calculated.
Time Frame
Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours
Title
Trough Plasma Concentration at Steady State (Ctrough) of GLASSIA
Description
Ctrough of GLASSIA was not assessed due to the termination of the study.
Time Frame
Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female participants aged ≥18 years at the time of screening
Recipient of an hematopoietic stem cell transplantation (HSCT)
The disease indication for which the participant required HSCT must be in remission
Newly diagnosed acute graft-versus-host disease (GvHD), including lower Gastrointestinal (GI) involvement (modified International Bone Marrow Transplant Registry [IBMTR] Severity Stage 1 to 4 [>500 mL diarrhea/day]), with or without other organ system involvement.
Willing to undergo or must have had a lower GI biopsy within 7 days of informed consent to confirm GI GvHD. Biopsy results are not needed to initiate treatment; however, if biopsy results are not consistent with aGvHD, treatment with GLASSIA will be discontinued.
Participants must be receiving systemic corticosteroids. Treatment with methylprednisolone/systemic steroids must have been initiated within 72 hours prior to the first dose of study treatment after enrollment
Evidence of myeloid engraftment (absolute neutrophil count ≥0.5 x 10^9/L)
Lower GI GvHD manifested by diarrhea must have other causes of diarrhea ruled out (eg, negative for Clostridium difficile or cytomegalovirus [CMV] infection or oral magnesium administration)
Karnofsky Performance Score ≥50%
If female of childbearing potential, participant presents with a negative blood pregnancy test
Females of childbearing potential with a fertile male sexual partner must agree to employ adequate contraception for the duration of the study.
Males must use adequate contraception and must not donate sperm for the duration of the study.
Participant is willing and able to comply with the requirements of the protocol
Exclusion Criteria:
Participant with manifestations of chronic GvHD
Participant with acute/chronic GvHD overlap syndrome
Participant whose GvHD developed after donor lymphocyte infusion
Participant with myocardial infarction within 6 months prior to enrollment or New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to the first dose of study treatment, any electrocardiogram (ECG) abnormality at screening must be documented by the investigator as not medically relevant
Participant with evidence of recurrent malignancy
Participant with veno-occlusive disease (ie, sinusoidal obstruction syndrome)
Participant receiving GvHD treatment other than continued prophylaxis (eg, cyclosporine and/or mycophenolate mofetil, etc) or corticosteroid therapy. In addition, a participant who received the first dose of corticosteroid therapy for acute GvHD with lower GI involvement more than 72 hours before the first dose of study treatment is not eligible for the study
Participant with severe sepsis involving at least 1 organ failure
Participant who is seropositive or positive in the nucleic acid test for human immunodeficiency virus (HIV)
Participant with active hepatitis B or C
Participant has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
If female, participant is pregnant or lactating at the time of enrollment, or has plans to become pregnant during the study
Participant with a serious medical or psychiatric illness likely to interfere with participation in the study
Participant is a family member or employee of the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Shire
Official's Role
Study Director
Facility Information:
Facility Name
Georgia Cancer Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the low number of study participants).
Learn more about this trial
A Phase 2/3 Study of GLASSIA for the Treatment of Acute GvHD
We'll reach out to this number within 24 hrs