Study Comparing Weekly Intravenous Administration of OctaAlpha1 With a Marketed Preparation Glassia® in Subjects With Alpha-1-antitrypsin Deficiency

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Brief Title

Study Comparing Weekly Intravenous Administration of OctaAlpha1 With a Marketed Preparation Glassia® in Subjects With Alpha-1-antitrypsin Deficiency

Official Title

A Randomized, Double-blind, Parallel-group, Multicenter, Pharmacokinetic Study Comparing Weekly Intravenous Administration of OctaAlpha1 (Octapharma) With a Marketed Preparation Glassia® (Kamada Ltd.) in Subjects With Alpha-1-antitrypsin Deficiency

Brief Summary

      This randomized trial is being conducted to show non-inferiority of OctaAlpha1 compared to
      Glassia® in terms of the serum trough levels at steady state. This will be conducted in
      individuals with alpha-1-antitrypsin deficiency and clinical evidence of emphysema.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Non-inferiority of OctaAlpha1 compared to Glassia® in terms of the serum trough levels at steady state

Secondary Outcome

 Compare PK parameters following a single dose between the two treatment groups following principles of bio-equivalence testing (AUC)

Condition

Alpha 1-Antitrypsin Deficiency

Intervention

OctaAlpha1

Study Arms / Comparison Groups

 OctaAlpha1
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

0

Start Date

July 2018

Completion Date

December 2019

Primary Completion Date

December 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Any subject who needs chronic IV augmentation and maintenance therapy with A1PI
             because of congenital alpha-1-proteinase inhibitor (A1PI) deficiency and clinically
             diagnosed emphysema

          -  ≥18 years of age

          -  Individuals with A1PI serum concentration <11 µM at screening

          -  Following bronchodilators:

               -  Initial FEV1(pred) between 25% and 75% or

               -  If the initial FEV1 was greater than 75% of predicted, a diffusing capacity of
                  the lung for carbon monoxide (DLC O) less than 70% of predicted

          -  Following bronchodilators: Initial forced expiratory volume/forced vital capacity
             (FEV1/FVC) ratio less than 70%

          -  Non-smoking for at least 6 months before study treatment starts

          -  Able to understand and provide written informed consent

          -  Women of reproductive age: negative result of pregnancy test (human chorionic
             gonadotropin [HCG]-based assay) and agreement to use adequate contraception for the
             duration of the trial

        Exclusion Criteria:

          -  Any inflammatory condition or malignant tumor in the 7 days before treatment starts
             that according to investigator judgment might influence the metabolism of an enzyme
             inhibitor such as A1PI

          -  More than one A1PI-deficiency related exacerbation and/or hospitalization during the 3
             months before study treatment starts

          -  Clinically significant liver or kidney disease in the preceding 6 months before study
             treatment starts

          -  Severe gas exchange abnormality (i.e., PaCO2 ≥46 mmHg)

          -  Known IgA deficiency with documented antibodies against IgA

          -  History of hypersensitivity to blood or plasma derived products, or any component of
             the product

          -  Known presence of antibodies against A1PI

          -  Seropositivity for HBsAg or HCV, HIV-1/2 IgG antibodies

          -  Administration of A1PI products in the 4 weeks before study treatment starts

          -  Participating in another clinical study currently or during the 3 months before study
             treatment starts.

          -  Live viral vaccination within the last month before study treatment starts

          -  A current life-threatening malignancy

          -  Emergency operation within 3 months before study treatment starts

          -  History of, or suspected, alcohol or drug abuse within 1 year before study treatment
             starts or currently on drug abuse therapy

          -  Pregnant and nursing women
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 



Administrative Informations


NCT ID

NCT03385395

Organization ID

OctaAlpha1


Responsible Party

Sponsor

Study Sponsor

Octapharma


Study Sponsor

, , 


Verification Date

April 2018