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Clinical Trials/JPRN-jRCT2080223105
JPRN-jRCT2080223105
Unknown
Phase 1

Phase I/II Multicenter, Open-label Trial to Evaluate the Safety and Pharmacokinetics of Alpha-1 MP in Patients with Alpha1-Antitrypsin Deficiency

Grifols Japan K.K.0 sites3 target enrollmentFebruary 17, 2016
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ConditionsAlpha1-antitrypsin deficiency

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Alpha1-antitrypsin deficiency
Sponsor
Grifols Japan K.K.
Enrollment
3
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 17, 2016
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Grifols Japan K.K.

Eligibility Criteria

Inclusion Criteria

  • •Main inclusion criteria:
  • •\- Subjects with clinically apparent pulmonary emphysema diagnosed by CT scan
  • •\- Subjects with serum alpha1\-PI levels of \<50 mg/dL
  • •\- Subjects whose percentage of force expired volume in 1 second/Forced vital capacity (FEV1/FVC) after inhalation of a bronchodilator is \<70 %

Exclusion Criteria

  • •Main exclusion criteria:
  • •\- Subjects with moderately or severely deteriorated lung function within 4 weeks
  • •\- Subjects whose percentage of forced expired volume in 1 second (%FEV1\) after inhalation of a bronchodilator is \<30%
  • •\- Subjects who have undergone lung transplantation or liver transplantation

Outcomes

Primary Outcomes

Not specified

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