Study of Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus

PHASE2TerminatedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

January 31, 2017

Study Completion Date

June 30, 2017

Conditions
Type 1 Diabetes Mellitus
Interventions
BIOLOGICAL

180 mg/kg Alpha1-PI

BIOLOGICAL

90 mg/kg Alpha1-PI

BIOLOGICAL

Placebo

Trial Locations (36)

14222

Women and Children's Hospital, Buffalo

15224

Children's Hospital of Pittsburgh, Pittsburgh

19106

Children's Hospital of Philadelphia, Philadelphia

19713

Christiana Care Health Services, Newark

21229

Barry J. Reiner MD, LLC., Baltimore

27610

WakeMed Children's Hospital, Raleigh

30309

Atlanta Diabetes Associates, Atlanta

32258

Solutions Through Advanced Research Inc., Jacksonville

33133

CCM Clinical Research, Miami

33136

Advanced Pharma CR LLC, Miami

40202

University of Louisville, Louisville

43201

Endocrinology Associates Inc, Columbus

43210

Ohio State University, Columbus

46202

Methodist Research Institute, Indianapolis

48201

Wayne State University, Detroit

52242

University of Iowa Hospitals and Clinics, Iowa City

55102

Children's Hospitals and Clinics of Minnesota, Saint Paul

57701

Rapid City Regional Hospital/Health Clinical Research, Rapid City

60612

Cook County Hospital, Chicago

73112

Pediatric Endocrinology, Genetics & Metabolism, Oklahoma City

75231

Research Institute of Dallas, Dallas

75390

University of Texas Southwestern Medical Center, Dallas

78154

Northeast Clinical Research of San Antonio LLC, San Antonio

78229

University of Texas Health Science Center, San Antonio

78232

Consano Clinical Research, San Antonio

83404

Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls

85724

University of Arizona, Tucson

90015

Clinica Medica San Miguel, Los Angeles

91356

Metabolic Institute of America, Tarzana

92123

Rady Children's Hospital San Diego, San Diego

92868

Diabetes Associates Medical Group, Orange

93003

Ronald H Chochinov MD, Ventura

06511

Yale New Haven Hospital, New Haven

01655

UMass Memorial Medical Center, Worcester

07962

Morristown Medical Center, Morristown

87131-0001

University of New Mexico, Health Sciences Center, Albuquerque

Sponsors
All Listed Sponsors
lead

Grifols Therapeutics LLC

INDUSTRY