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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03805789
Other study ID # CSL964_2001
Secondary ID 2018-000329-29
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date March 27, 2019
Est. completion date March 2027

Study information

Verified date February 2024
Source CSL Behring
Contact Trial Registration Coordinator
Phone 610-878-4000
Email clinicaltrials@cslbehring.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a Phase 2/3 prospective, double-blind, randomized, multi-center, placebo-controlled study for prevention of acute GVHD (aGVHD) in subjects undergoing an allogeneic hematopoietic cell transplant (HCT).


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Study Design


Intervention

Biological:
Alpha-1 antitrypsin (AAT)
Alpha-1 antitrypsin is a lyophilized product for intravenous administration.
Placebo
Albumin solution administered intravenously

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Sponsors (1)

Lead Sponsor Collaborator
CSL Behring

Countries where clinical trial is conducted

United States,  Australia,  Germany,  Italy,  Japan,  Korea, Republic of,  Spain,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The time to Grade II-IV acute graft versus host disease (aGVHD) or death Acute graft vs host disease (aGVHD) will be assessed using the modified Keystone GVHD scoring system. Through 180 days after hematopoietic cell transplantation (HCT)
Secondary Proportion of subjects with lower GI aGVHD or Grade III-IV aGVHD in any organ Through 180 days after HCT
Secondary Proportion of subjects with severe infections defined by NCI-CTCAE = Grade 3 Through Day 60 after HCT
Secondary Proportion of subjects with Grade II-IV aGVHD or death Through 100 days and 180 days after HCT
Secondary Proportion of subjects with lower GI aGVHD Through Days 60, 100 and 180 after HCT
Secondary Proportion of subjects with severe infections defined by NCI-CTCAE = Grade 3 Through 100 and 180 days after HCT
Secondary Number of deaths (relapse and nonrelapse-related) Death by any cause Within 180, 365, and 730 days after HCT
Secondary Proportion of subjects with Grade III-IV aGVHD or death Through Days 60, 100, and 180 days after HCT
Secondary Proportion of subjects with moderate-to-severe chronic GVHD Moderate-to-severe chronic GVHD graded according to NIH scale Within 180, 365, 545, and 730 days after HCT
Secondary Proportion of subjects who have discontinued immune suppression therapies including standard- of- care GVHD prophylaxis and steroid treatment Within 180 and 365 days after HCT
Secondary Time to neutrophil engraftment Time to the first of 3 consecutive days of absolute neutrophil counts = 500/µL Through 365 days after HCT
Secondary Time to GVHD relapse-free survival GVHD free, relapse free, survival defined as time to any of the following events: 1) Grade II-IV acute GVHD, 2) moderate-severe chronic GVHD, 3) primary malignancy relapse or 4) death. Within 365 and 730 days after HCT
Secondary Proportion of subjects with relapse of primary malignancies Through 180, 365, and 730 days after HCT
Secondary Proportion of subjects with Grade II-IV aGVHD with an overall (complete + partial) response, complete response and partial response Approximately 4 weeks after the initiation of systemic steroids during 8-week Treatment Period
Secondary Percent of subjects with study drug related adverse events Up to 365 days after HCT
Secondary Maximum concentration (Cmax) of AAT Before and up to 72 after infusion of AAT
Secondary Area under the concentration curve (AUC) for AAT Before and up to 72 after infusion of AAT
Secondary Clearance (CL) of AAT Before and up to 72 after infusion of AAT
Secondary Volume of distribution (V) for AAT Before and up to 72 after infusion of AAT
Secondary Ctrough of AAT Before and up to 72 after infusion of AAT
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