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
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Administrative Informations
NCT ID
NCT03385395
Organization ID
OctaAlpha1
Responsible Party
Sponsor
Study Sponsor
Octapharma
Study Sponsor
, ,
Verification Date
April 2018