deltatrials
Terminated PHASE2 INTERVENTIONAL 6-arm NCT02093221

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

A Multicenter, Randomized, Partial-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus

Sponsor: Grifols Therapeutics LLC

Conditions Type 1 Diabetes Mellitus
Interventions 180 mg/kg Alpha1-PI 90 mg/kg Alpha1-PI Placebo
Last updated: Aug 6, 2018 Started: Mar 31, 2014 Primary completion: Jan 31, 2017 Completion: Jun 30, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Wk 52 primary endpoint results would be unaffected by follow-up data so trial was discontinued prior to wk 104. No safety data was collected after wk 52.

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A PHASE2 clinical study on Type 1 Diabetes Mellitus, this trial is terminated or withdrawn. The trial is conducted by Grifols Therapeutics LLC and has accumulated 0 data snapshots since 2014. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Change History

No change history available.

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Grifols Therapeutics LLC
Data source: Grifols Therapeutics LLC

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Albuquerque, United States , Atlanta, United States , Baltimore, United States , Buffalo, United States , Chicago, United States , Columbus, United States , Dallas, United States , Detroit, United States , Idaho Falls, United States , Indianapolis, United States and 21 more locations