Alpha 1-Antitrypsin DeficiencyPhase 2/3Kamada APINCT00460096
Phase II/III Study of an Alpha-1 Proteinase Inhibitor (Kamada-API) in Individuals With Alpha-1 Antitrypsin Deficiency
A Phase 2/3 study testing Kamada-API in people with Alpha 1-Antitrypsin Deficiency, run by Kamada, Ltd. at 3 sites in United States.
Trial summary
The primary purpose of this Phase II/III study is to demonstrate that Kamada-API, a new API concentrate manufactured by Kamada Ltd., is comparable to a currently marketed API product. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alpha 1-Antitrypsin Deficiency
- What is being tested?
- Kamada-API
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2007to Sep 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- "At-risk" alleles associated with serum AAT < 11 μM including null alleles and deficiency alleles. This must be documented in the subject's history or laboratory tests performed at screening.
- At least 18 years of age.
- Evidence of lung disease related to AAT deficiency, identified by at least one of the following:
- FEV1<80% predicted (post BD); or
- Loss of lung function over a one year period of greater than 35ml in FEV1; or
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- HRCT evidence of pulmonary emphysema
- For actively treated subjects, agreement to not receive any exogenous API product (i.e. washout) for five weeks prior to first study infusion.
- Use of an effective means of contraception during the 24 weeks of study drug administration (this is applicable to both sexes).
- Subjects on the BAL, bronchial brushing/biopsy group must be on inhaled corticosteroids at a stable dose two weeks prior the first Bronchoscopy and throughout the dosing period up the final bronchoscopy.
Who cannot join
- Laboratory evidence of severe IgA deficiency (from medical history or by IgA testing at screening of at least 20% of lower range).
- Current smoker or a history of smoking within the past 3 months.
- History of allergy to plasma proteins.
- Participation in another experimental drug or device trial within the past 30 days.
- Evidence of uncontrolled hypertension (systolic ≥180 mm Hg, and/or diastolic ≥ 110 mm Hg on 3 consecutive occasions in the supine position)
- Pulse ≥ 120/min (prior to the 1st infusion).
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- Abnormal screening or baseline laboratory measurements that in the opinion of the Investigator would affect subject safety.
- Pregnancy or lactation.
- Current life-threatening malignancy.
- Previous organ transplant recipient.
- History of infection with HCV, HBV and/or HIV 1 or 2, or (at baseline) infection indicated by laboratory measurements obtained at screening.
- Acute respiratory tract infection or COPD exacerbation which required antibiotic and/or systemic steroid treatment within the past 6 weeks. Patient can be re-evaluated for enrollment 6 weeks after an exacerbation.
- Any other condition which in the judgment of the investigator may interfere with the conduct of the study.
- If an adequate home health care agency cannot be established by Centric Health Resources due to a potential subject's geographical location.
- Exclusion criteria for subjects entering into the BAL and bronchial biopsy/brushing:
- FEV1 < 45% predicted (post-BD).
- Inability to undergo bronchoscopy.
- Allergy to lidocaine.
- Exacerbation of COPD in the previous 6 weeks.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
National Jewish Medical and Research Center
Denver, Colorado, 80206
University of Florida School of Medicine
Gainesville, Florida, 32610
The University of Texas Health Center at Tyler
Tyler, Texas, 75708-3154
About this study
Official title: Randomized Double-Blind Comparison of an Alpha-1 Proteinase Inhibitor (Kamada API) With a Currently Marketed API Product in Individuals With Alpha-1 Antitrypsin Deficiency
The primary purpose of this Phase II/III study is to demonstrate that Kamada-API, a new API concentrate manufactured by Kamada Ltd., is comparable to a currently marketed API product.
Read the detailed description
Alpha-1 Antitrypsin Deficiency, also called Alpha-1-Proteinase Inhibitor (API) deficiency, is a genetic disorder characterized by the production of an abnormal amount of AAT protein and reduced circulating levels of this protein. Subjects with AAT deficiency are at increased risk for developing chronic obstructive pulmonary disease (COPD). It is believed that this is the result of the chronic activity of elastase released by cells continually present in the lungs in low numbers.
This study is a randomized, double-blind comparison of Kamada API, an Alpha-1-Proteinase Inhibitor with a currently marketed API product.
- Conditions
- Alpha 1-Antitrypsin Deficiency
- Being tested
- Kamada-API
- Keywords
- Pulmonary Emphysema
- Medical subject headings
- alpha 1-Antitrypsin Deficiency, Pulmonary Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kamada-APIDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Secondary outcomes (1)
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2007 (estimated)
- Study startMar 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alpha 1-Antitrypsin DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kamada, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert A Sandhaus, M.D., Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460096
- Sponsor's protocol ID
- Kamada API-002
- Acronym
- Kamada API
- Status last verified
- Oct 2007
- First submitted
- 12 Apr 2007
- Last updated
- 17 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sandhaus RA, Stocks J, Rouhani FN, Brantly M, Strauss P. Biochemical efficacy and safety of a new, ready-to-use, liquid alpha-1-proteinase inhibitor, GLASSIA (alpha1-proteinase inhibitor (human), intravenous). COPD. 2014 Feb;11(1):17-25. doi: 10.3109/15412555.2013.804500. Epub 2013 Jul 3.
PubMed 23822603
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Blind Comparison of an Alpha-1 Proteinase Inhibitor (Kamada API) With a Currently Marketed API Product in Individuals With Alpha-1 Antitrypsin Deficiency
- ClinicalTrials.gov ID
- NCT00460096
- Acronym / sponsor ID
- Kamada API / Kamada API-002
- Conditions
- Alpha 1-Antitrypsin Deficiency
- Keywords
- Pulmonary Emphysema
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kamada, Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2007
- Study completion
- Sep 2007 (actual)
- First posted
- 13 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this Phase II/III study is to demonstrate that Kamada-API, a new API concentrate manufactured by Kamada Ltd., is comparable to a currently marketed API product.
Detailed description
Alpha-1 Antitrypsin Deficiency, also called Alpha-1-Proteinase Inhibitor (API) deficiency, is a genetic disorder characterized by the production of an abnormal amount of AAT protein and reduced circulating levels of this protein. Subjects with AAT deficiency are at increased risk for developing chronic obstructive pulmonary disease (COPD). It is believed that this is the result of the chronic activity of elastase released by cells continually present in the lungs in low numbers.
This study is a randomized, double-blind comparison of Kamada API, an Alpha-1-Proteinase Inhibitor with a currently marketed API product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent.
- "At-risk" alleles associated with serum AAT < 11 μM including null alleles and deficiency alleles. This must be documented in the subject's history or laboratory tests performed at screening.
- At least 18 years of age.
- Evidence of lung disease related to AAT deficiency, identified by at least one of the following:
- For actively treated subjects, agreement to not receive any exogenous API product (i.e. washout) for five weeks prior to first study infusion.
Key exclusion criteria (19 listed)
- Laboratory evidence of severe IgA deficiency (from medical history or by IgA testing at screening of at least 20% of lower range).
- Current smoker or a history of smoking within the past 3 months.
- History of allergy to plasma proteins.
- Participation in another experimental drug or device trial within the past 30 days.
- Evidence of uncontrolled hypertension (systolic ≥180 mm Hg, and/or diastolic ≥ 110 mm Hg on 3 consecutive occasions in the supine position)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kamada-API | Drug | – |
Primary outcome
Efficacy
1 secondary outcome
Safety
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2007.
- Derived from this study: PubMed 23822603Sandhaus RA, Stocks J, Rouhani FN, Brantly M, Strauss P. Biochemical efficacy and safety of a new, ready-to-use, liquid alpha-1-proteinase inhibitor, GLASSIA (alpha1-proteinase inhibitor (human), intravenous). COPD. 2014 Feb;11(1):17-25. doi: 10.3109/15412555.2013.804500. Epub 2013 Jul 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert A Sandhaus, M.D. principal investigator
National Jewish Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Kamada-API in people with Alpha 1-Antitrypsin Deficiency, run by Kamada, Ltd. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00460096, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2007.