Graft Versus Host DiseasePhase 2/3NCT02956122
A Phase 2/3 Study of GLASSIA for the Treatment of Acute GvHD
A Phase 2/3 study testing GLASSIA, methylprednisolone or equivalent steroid and Albumin in people with Graft Versus Host Disease, run by Baxalta now part of Shire at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Versus Host Disease
- What is being tested?
- GLASSIA, methylprednisolone or equivalent steroid and Albumin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2017to 3 May 2018
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Graft Versus Host Disease
- Being tested
- GLASSIA, methylprednisolone or equivalent steroid, Albumin
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLASSIABiological
Also called as alpha-1 antitrypsin, A1PI, alpha-1 proteinase inhibitor
GLASSIA [Alpha1-Proteinase Inhibitor (Human)]
methylprednisolone or equivalent steroidDrug
The conventional steroid treatment (methylprednisolone or equivalent steroid) will be supplied by the investigators per their institutional practice.
AlbuminBiological
Also called Human Albumin
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).
| Study group | Role | What they receive |
|---|---|---|
| Study Part 1 - All Participants - GLASSIA | Experimental | Participants to receive GLASSIA (intravenously) and methylprednisolone or equivalent steroid (either IV or oral per investigator discretion) Receives: Biological: GLASSIA; Drug: methylprednisolone or equivalent steroid |
| Study Part 2 - GLASSIA | Experimental | Participants to receive GLASSIA (intravenously) and methylprednisolone or equivalent steroid (either IV or oral per investigator discretion) Receives: Biological: GLASSIA; Drug: methylprednisolone or equivalent steroid |
| Study Part 2 - Albumin (Control) | Placebo comparator | Participants to receive control (intravenously) and methylprednisolone or equivalent steroid (either IV or oral per investigator discretion) Receives: Drug: methylprednisolone or equivalent steroid; Biological: Albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 28
Secondary outcomes (25)
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.
Measured: Day 28
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.
Measured: Day 56
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.
Measured: Days 28, 56 and 180
Incidence of Chronic Graft-versus-host Disease (GvHD)
Incidence of chronic GvHD at Days 180 and 365 was reported.
Measured: Days 180 and 365
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.
Measured: Baseline up to Day 365
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.
Measured: Baseline up to Day 365
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.
Measured: Days 100, 180 and 365
Transplant-related Mortality
Transplant-related mortality was determined by the investigator (any deaths considered related to the transplant).
Measured: Days 28, 56, 100 and 180
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.
Measured: Days 100 and 180
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.
Measured: Days 28, 56, 100, 180 and 365
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}]).
Measured: Days 28, 56, 100 and 180
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).
Measured: Days 28, 56, 100 and 180
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.
Measured: Days 28, 56, 100 and 180
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.
Measured: From start of study drug administration up to 371 days
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.
Measured: Baseline up to Day 56
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.
Measured: Baseline up to Day 56
Number of Participants With Recurrence of Primary Malignancies
Incidence of recurrence of primary malignancies was reported.
Measured: Baseline up to Day 365
Area Under the Plasma Concentration Curve (AUC0-inf) From Time Zero to Infinity
AUC of GLASSIA was reported.
Measured: Day 1: through 48 hours; Day 13: through 48 hours; Day 22 and Day 50: through approximately 168 hours
Area Under the Plasma Concentration Curve From Time Zero to Time "t" AUC(0-t) of GLASSIA
AUC(0-t) of GLASSIA was reported.
Measured: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours
Systemic Clearance at Steady State (CLss) of GLASSIA
CLss of GLASSIA was reported.
Measured: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours
Maximum Observed Plasma Concentration (Cmax) of GLASSIA
Cmax of GLASSIA was reported.
Measured: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours
Apparent Volume of Distribution at Steady State (Vss) of GLASSIA
Vss of GLASSIA was reported.
Measured: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours
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.
Measured: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours
Mean Residence Time (MRT) of GLASSIA
MRT of GLASSIA was not calculated.
Measured: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours
Trough Plasma Concentration at Steady State (Ctrough) of GLASSIA
Ctrough of GLASSIA was not assessed due to the termination of the study.
Measured: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study start26 Apr 2017
- Primary completion3 May 2018
- Study completion3 May 2018
Why it stopped: The decision to discontinue the study was based on business reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Graft Versus Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxalta now part of Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kamada, Ltd.
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Shire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956122
- Sponsor's protocol ID
- 471501
- Status last verified
- Dec 2020
- First submitted
- 24 Oct 2016
- Last updated
- 13 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02956122
- Acronym / sponsor ID
- 471501
- Conditions
- Graft Versus Host Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The decision to discontinue the study was based on business reasons.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Baxalta now part of ShireIndustry (pharma, biotech, devices)
- Collaborators
- Kamada, Ltd.
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 3 May 2018 (actual)
- Study completion
- 3 May 2018 (actual)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Posted 24 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study Part 1 - All Participants - GLASSIA | Experimental | Biological: GLASSIA, Drug: methylprednisolone or equivalent steroidParticipants to receive GLASSIA (intravenously) and methylprednisolone or equivalent steroid (either IV or oral per investigator discretion) |
| Study Part 2 - GLASSIA | Experimental | Biological: GLASSIA, Drug: methylprednisolone or equivalent steroidParticipants to receive GLASSIA (intravenously) and methylprednisolone or equivalent steroid (either IV or oral per investigator discretion) |
| Study Part 2 - Albumin (Control) | Placebo comparator | Drug: methylprednisolone or equivalent steroid, Biological: AlbuminParticipants to receive control (intravenously) and methylprednisolone or equivalent steroid (either IV or oral per investigator discretion) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLASSIAAlso: as alpha-1 antitrypsin, A1PI, alpha-1 proteinase inhibitorGLASSIA [Alpha1-Proteinase Inhibitor (Human)] | Biological | Study Part 1 - All Participants - GLASSIA, Study Part 2 - GLASSIA |
| methylprednisolone or equivalent steroidThe conventional steroid treatment (methylprednisolone or equivalent steroid) will be supplied by the investigators per their institutional practice. | Drug | Study Part 1 - All Participants - GLASSIA, Study Part 2 - Albumin (Control), Study Part 2 - GLASSIA |
| AlbuminAlso: Human AlbuminThe 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). | Biological | Study Part 2 - Albumin (Control) |
Primary outcome
Percentage of Participants Achieving Overall Response (OR) At Day 28
Time frame: 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.
25 secondary outcomes
Percentage of Participants Achieving Gastrointestinal (GI) Response at Day 28
Time frame: Day 28
Percentage of Participants Achieving Overall Response at Day 56
Time frame: Day 56
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Time frame: Days 28, 56 and 180
Incidence of Chronic Graft-versus-host Disease (GvHD)
Time frame: Days 180 and 365
Duration of Overall Response (OR)
Time frame: Baseline up to Day 365
Duration of Gastrointestinal (GI) Response
Time frame: Baseline up to Day 365
Overall Survival (OS) - Percentage of Participants With an Event
Time frame: Days 100, 180 and 365
Transplant-related Mortality
Time frame: Days 28, 56, 100 and 180
Failure-free Survival - Percentage of Participants With an Event
Time frame: Days 100 and 180
Graft-versus-host Disease (GvHD)-Free Survival - Percentage of Participants With an Event
Time frame: Days 28, 56, 100, 180 and 365
Infection-related Mortality - Percentage of Participants With an Event
Time frame: Days 28, 56, 100 and 180
Graft-versus-host Disease (GvHD)-Related Mortality - Percentage of Participants With an Event
Time frame: Days 28, 56, 100 and 180
All-cause Mortality - Percentage of Participants With an Event
Time frame: Days 28, 56, 100 and 180
Number of Participants With Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs and Temporally-associated AEs
Time frame: From start of study drug administration up to 371 days
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
Time frame: Baseline up to Day 56
Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: Baseline up to Day 56
Number of Participants With Recurrence of Primary Malignancies
Time frame: Baseline up to Day 365
Area Under the Plasma Concentration Curve (AUC0-inf) From Time Zero to Infinity
Time frame: Day 1: through 48 hours; Day 13: through 48 hours; Day 22 and Day 50: through approximately 168 hours
Area Under the Plasma Concentration Curve From Time Zero to Time "t" AUC(0-t) of GLASSIA
Time frame: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours
Systemic Clearance at Steady State (CLss) of GLASSIA
Time frame: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours
Maximum Observed Plasma Concentration (Cmax) of GLASSIA
Time frame: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours
Apparent Volume of Distribution at Steady State (Vss) of GLASSIA
Time frame: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours
Apparent Terminal Half-life (t1/2) of GLASSIA
Time frame: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours
Mean Residence Time (MRT) of GLASSIA
Time frame: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours
Trough Plasma Concentration at Steady State (Ctrough) of GLASSIA
Time frame: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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).
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Graft vs Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Shire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing GLASSIA, methylprednisolone or equivalent steroid and Albumin in people with Graft Versus Host Disease, run by Baxalta now part of Shire at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Overall Response (OR) At Day 28 (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.