Arthritis, RheumatoidPhase 1/2NCT00126724
Study of Intra-articular Delivery of tgAAC94 in Inflammatory Arthritis Subjects
A Phase 1/2 study testing tgAAC94 gene therapy vector in people with Arthritis, Rheumatoid and Arthritis, Psoriatic, run by Targeted Genetics Corporation at 22 sites in United States.
Trial summary
The 13G01 clinical trial is a Phase I/II dose escalation study designed to be conducted in adults with inflammatory arthritis who have persistent moderate or severe swelling in one or more joints, without a disease severe enough to warrant a change in regimen for the next three months. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Ankylosing Spondylitis
- What is being tested?
- tgAAC94 gene therapy vector
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 22 sitesUnited States
- Study dates
- Aug 2005to May 2009
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) diagnosed according to established criteria.
- Persistent moderate (grade 2) or severe (grade 3) swelling due to inflammatory arthritis in at least one peripheral joint eligible for injection.
- For subjects with RA, an adequate trial of at least one disease-modifying drug (DMARD) prior to screening.
- For subjects currently on DMARD(s), a stable regimen of inflammatory arthritis for the previous three months, with no changes in doses four weeks prior to screening.
- Age greater than 18 years and less than 75 years at the time of screening.
- Willingness to practice effective birth control measures during the study (through week 36), if male or female of reproductive ability.
- Able to give written informed consent.
Who cannot join
- Disease severe enough to warrant a change in regimen for inflammatory arthritis in the next three months.
- Discontinuation of etanercept in the past because of safety concerns.
- Current use of anakinra (Kineret®)or abatacept (Orencia®).
- Corticosteroid therapy at doses higher than the equivalent of 10 mg prednisone per day.
- Steroid or hyaluronate injection in the target joint or receipt of an investigational agent less than four weeks prior to screening.
- Class IV ACR functional status (Hochberg et al., 1992).
Show all 13Show fewer
- Any of the following laboratory values: Hemoglobin <8.5 gm/dL, white blood cell count <3500 per mm cube, platelet <100 K/uL, creatinine >2 mg/dL, bilirubin >2 mg/dL, AST or ALT >2 times the upper limit of normal, or abnormal coagulation profiles (>2 seconds beyond upper range of normal PT or PTT).
- Known HIV infection, known hepatitis C infection, or known positive serologic test for hepatitis B surface antigen.
- Positive PPD, unless previously treated with appropriate prophylaxis.
- Pregnancy or lactation, either at the time of screening or planned in the next 18 months.
- Inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.
- Serious medical disease, such as severe liver or kidney disease, uncompensated congestive heart failure, myocardial infarction within six months, unstable angina, uncontrolled hypertension, severe pulmonary disease or uncontrolled asthma, demyelinating neurological disease, history of cancer (other than cutaneous basal and squamous cell carcinoma) with less than five years documentation of a disease-free state, insulin-dependent diabetes, recurrent opportunistic infections or other concurrent medical condition that, in the opinion of the investigator, would make the subject unsuitable for the study.
- Unlikely to comply with protocol.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Austin Rheumatology Research
Austin, Texas, 78705
RASF-Clinical Research Center
Boca Raton, Florida, 33486
Northwestern Center for Clinical Research
Chicago, Illinois, 60611
Coeur d'Alene Arthritis Clinic
Coeur d'Alene, Idaho, 83814
Arthritis Consultation Center
Dallas, Texas, 75231
Metroplex Clinical Research Center
Dallas, Texas, 75235
Denver Arthritis Research Center
Denver, Colorado, 80230
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Arthritis and Osteoporosis Center of Maryland
Frederick, Maryland, 21702
Sun Valley Arthritis Center
Glendale, Arizona, 85308
United Medical Associates
Johnson City, New York, 13790
Ocala Rheumatology Research Center
Ocala, Florida, 34474
Bone and Joint Hospital Research Dept.
Oklahoma City, Oklahoma, 73103
Desert Medical Advances
Palm Desert, California, 92260
Arthritis Center of Reno
Reno, Nevada, 89502
Radiant Research San Antonio Northeast
San Antonio, Texas, 78217
Seattle Rheumatology Associates, PLLC
Seattle, Washington, 98104
The Arthritis Center
Springfield, Illinois, 62704
Radiant Research Stuart
Stuart, Florida, 34996
Catalina Pointe Clinical Research, Inc
Tuscon, Arizona, 85704
Boling Clinical Trials
Upland, California, 91786
Rheumatic Disease Associates
Willow Grove, Pennsylvania, 19090
About this study
Official title: A Phase I/II Study of Repeat Intra-articular Administration of tgAAC94, a Recombinant Adeno-Associated Vector Containing the TNFR:Fc Fusion Gene, in Inflammatory Arthritis Subjects With and Without Concurrent TNF-alpha Antagonists
The 13G01 clinical trial is a Phase I/II dose escalation study designed to be conducted in adults with inflammatory arthritis who have persistent moderate or severe swelling in one or more joints, without a disease severe enough to warrant a change in regimen for the next three months.
The study will permit subjects who are concurrently on anti-tumor necrosis factor (TNF)-alpha antagonists. For subjects on disease modifying antirheumatic drugs (DMARDs), a stable regimen for inflammatory arthritis for the previous three months, with no changes in doses in the four weeks prior to screening will be required.
Read more
The primary objectives are:
- to evaluate the safety of intra-articular administration of tgAAC94 in subjects currently taking TNF-alpha antagonists, and
- to evaluate the safety of repeat intra-articular administration of tgAAC94 (gene therapy vector).
Read the detailed description
tgAAC94 is a recombinant adeno-associated virus serotype 2 (AAV2) vector genetically engineered to contain the cDNA for a human tumor necrosis factor receptor (TNFR)-immunoglobulin (IgG1) Fc fusion (TNFR:Fc) gene. The DNA sequence of TNFR:Fc in tgAAC94 codes for a protein sequence identical to etanercept (Enbrel®). TNF-alpha has been strongly implicated as a major participant in the inflammatory cascade that leads to joint damage and destruction in diseases such as rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS).
Intra-articular delivery of the TNFR:Fc gene (tgAAC94) should result in expression of the secreted protein in the joint space and provide local high concentrations of soluble TNFR:Fc for an extended period of time without requiring frequent administration. Thus, this proposed therapy would be useful in those inflammatory arthritis patients who have a persistently problematic joint despite the use of systemic TNF-alpha blockade or who have a limited number of arthritic joints.
Extensive preclinical studies using rAAV2 containing several different transgenes in a variety of animal models have shown efficient and persistent gene transfer and expression with minimal toxicity. The parent virus (wild-type AAV2) is a naturally occurring, non-replicating virus that depends on a helper virus, such as adenovirus, for replication. The recombinant AAV2 vector is unable to replicate in target host cells because it lacks the AAV genes, whose protein products are also required in trans, for replication and packaging of progeny virus. Extensive epidemiological studies have found AAV2 to be non-pathogenic.
Although there is no cure for arthritis, treatment has been revolutionized by the advent of anti-TNF-alpha therapies. These include etanercept (Enbrel®), infliximab (Remicade®) and adalimumab (Humira®), which consist of soluble TNF receptors, chimeric human-mouse anti-TNF-alpha monoclonal antibodies and fully human anti-TNF-alpha monoclonal antibodies, respectively. Clinical studies have shown these products to improve the signs and symptoms, inhibit the structural damage, and impact functional outcomes in patients with these inflammatory arthritides.
- Being tested
- tgAAC94 gene therapy vector, tgAAC94 placebo
- Keywords
- tgAAC94, Rheumatoid arthritis, Inflammatory arthritis, Arthritis, Gene therapy, AAV
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Spondylitis, Ankylosing, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tgAAC94 gene therapy vectorGenetic
Single Dose 1x10^11 DRP/mL
tgAAC94 gene therapy vectorGenetic
Second dose of 1x10^11 DRP/mL tgAAC94 administered once target joint reaches predetermined criteria for re-injection (on or after Week 12) at the same concentration as initial dose.
tgAAC94 placeboGenetic
placebo
tgAAC94 gene therapy vectorGenetic
Single Dose 1x10^12 DRP/mL tgAAC94
tgAAC94 gene therapy vectorGenetic
Second dose of 1x10^12 DRP/mL tgAAC94 administered once target joint reaches predetermined criteria for re-injection (on or after Week 12) at the same concentration as initial dose.
tgAAC94 gene therapy vectorGenetic
Single Dose 1x10^13 DRP/mL tgAAC94
tgAAC94 gene therapy vectorGenetic
Second dose of 1x10^13 DRP/mL tgAAC94 administered once target joint reaches predetermined criteria for re-injection (on or after Week 12) at the same concentration as initial dose.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 1x10^11 DRP/mL tgAAC94 Receives: Genetic: tgAAC94 gene therapy vector |
| 2 | Active comparator | 1x10^12 DRP/mL tgAAC94 Receives: Genetic: tgAAC94 gene therapy vector |
| 3 | Active comparator | 1x10^13 DRP/mL tgAAC94 Receives: Genetic: tgAAC94 gene therapy vector |
| 4 | Placebo comparator | Not described Receives: Genetic: tgAAC94 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious adverse events
Measured: From time of study drug administration through final study visit
Severe or very severe adverse events
Measured: From time of study drug administration through final study visit
Study-drug related adverse events
Measured: From time of study drug administration through final study visit
Secondary outcomes (6)
Change in tenderness and swelling of target joint
Measured: All scheduled study visits
Time to qualifying for second injection of study drug
Measured: Week A12 or 18 or 24
Reduction in disease activity, as measured by American College of Rheumatology (ACR) criteria, Disease Activity Score (DAS) or Assessments in Ankylosing Spondylitis (ASAS) criteria, as applicable
Measured: Day A0, Weeks A4, 8, 12, 18, 24, Day B0, Weeks B4, B8, B12, B18, B24, B30, withdrawal
Human tumor necrosis factor receptor (TNFR)-immunoglobulin (IgG1) Fc fusion (TNFR:Fc) protein levels in synovial fluid and serum
Measured: Serum: Days A0,7,Weeks A4,12,24, Days B0,7,Weeks 8,12,18,24,30, withdrawal. Synovium: Days A0,4,Weeks A12,24, Day B0,Weeks 4,12,24, withdrawal
Serum anti-adeno-associated virus serotype 2 (AAV2) capsid neutralizing antibodies
Measured: Day A0, Weeks A4, 12, 24, Day B0, Weeks B4, 12,24, 30, withdrawal
Joint inflammation and damage on MRI scan
Measured: Day A0, Weeks A4, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionOct 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Targeted Genetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alison Heald, MD, Study director, Targeted Genetics Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126724
- Sponsor's protocol ID
- 13G01
- Other IDs
- NIH Protocol Number: 0504-705
- Status last verified
- Jul 2009
- First submitted
- 2 Aug 2005
- Last updated
- 29 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Heald AE, Fudman EJ, Anklesaria P, Mease PJ; 13G01 Study Team. Single-joint outcome measures: preliminary validation of patient-reported outcomes and physical examination. J Rheumatol. 2010 May;37(5):1042-8. doi: 10.3899/jrheum.090827. Epub 2010 Mar 15.
PubMed 20231202Frank KM, Hogarth DK, Miller JL, Mandal S, Mease PJ, Samulski RJ, Weisgerber GA, Hart J. Investigation of the cause of death in a gene-therapy trial. N Engl J Med. 2009 Jul 9;361(2):161-9. doi: 10.1056/NEJMoa0801066.
PubMed 19587341
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Repeat Intra-articular Administration of tgAAC94, a Recombinant Adeno-Associated Vector Containing the TNFR:Fc Fusion Gene, in Inflammatory Arthritis Subjects With and Without Concurrent TNF-alpha Antagonists
- ClinicalTrials.gov ID
- NCT00126724
- Acronym / sponsor ID
- 13G01
- Keywords
- tgAAC94, Rheumatoid arthritis, Inflammatory arthritis, Arthritis, Gene therapy, AAV
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Targeted Genetics CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 4 Aug 2005 (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 13G01 clinical trial is a Phase I/II dose escalation study designed to be conducted in adults with inflammatory arthritis who have persistent moderate or severe swelling in one or more joints, without a disease severe enough to warrant a change in regimen for the next three months.
The study will permit subjects who are concurrently on anti-tumor necrosis factor (TNF)-alpha antagonists. For subjects on disease modifying antirheumatic drugs (DMARDs), a stable regimen for inflammatory arthritis for the previous three months, with no changes in doses in the four weeks prior to screening will be required.
The primary objectives are:
- to evaluate the safety of intra-articular administration of tgAAC94 in subjects currently taking TNF-alpha antagonists, and
- to evaluate the safety of repeat intra-articular administration of tgAAC94 (gene therapy vector).
Detailed description
tgAAC94 is a recombinant adeno-associated virus serotype 2 (AAV2) vector genetically engineered to contain the cDNA for a human tumor necrosis factor receptor (TNFR)-immunoglobulin (IgG1) Fc fusion (TNFR:Fc) gene. The DNA sequence of TNFR:Fc in tgAAC94 codes for a protein sequence identical to etanercept (Enbrel®). TNF-alpha has been strongly implicated as a major participant in the inflammatory cascade that leads to joint damage and destruction in diseases such as rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS).
Intra-articular delivery of the TNFR:Fc gene (tgAAC94) should result in expression of the secreted protein in the joint space and provide local high concentrations of soluble TNFR:Fc for an extended period of time without requiring frequent administration. Thus, this proposed therapy would be useful in those inflammatory arthritis patients who have a persistently problematic joint despite the use of systemic TNF-alpha blockade or who have a limited number of arthritic joints.
Extensive preclinical studies using rAAV2 containing several different transgenes in a variety of animal models have shown efficient and persistent gene transfer and expression with minimal toxicity. The parent virus (wild-type AAV2) is a naturally occurring, non-replicating virus that depends on a helper virus, such as adenovirus, for replication. The recombinant AAV2 vector is unable to replicate in target host cells because it lacks the AAV genes, whose protein products are also required in trans, for replication and packaging of progeny virus. Extensive epidemiological studies have found AAV2 to be non-pathogenic.
Although there is no cure for arthritis, treatment has been revolutionized by the advent of anti-TNF-alpha therapies. These include etanercept (Enbrel®), infliximab (Remicade®) and adalimumab (Humira®), which consist of soluble TNF receptors, chimeric human-mouse anti-TNF-alpha monoclonal antibodies and fully human anti-TNF-alpha monoclonal antibodies, respectively. Clinical studies have shown these products to improve the signs and symptoms, inhibit the structural damage, and impact functional outcomes in patients with these inflammatory arthritides.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Genetic: tgAAC94 gene therapy vector1x10^11 DRP/mL tgAAC94 |
| 2 | Active comparator | Genetic: tgAAC94 gene therapy vector1x10^12 DRP/mL tgAAC94 |
| 3 | Active comparator | Genetic: tgAAC94 gene therapy vector1x10^13 DRP/mL tgAAC94 |
| 4 | Placebo comparator | Genetic: tgAAC94 placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) diagnosed according to established criteria.
- Persistent moderate (grade 2) or severe (grade 3) swelling due to inflammatory arthritis in at least one peripheral joint eligible for injection.
- For subjects with RA, an adequate trial of at least one disease-modifying drug (DMARD) prior to screening.
- For subjects currently on DMARD(s), a stable regimen of inflammatory arthritis for the previous three months, with no changes in doses four weeks prior to screening.
- Age greater than 18 years and less than 75 years at the time of screening.
Key exclusion criteria (13 listed)
- Disease severe enough to warrant a change in regimen for inflammatory arthritis in the next three months.
- Discontinuation of etanercept in the past because of safety concerns.
- Current use of anakinra (Kineret®)or abatacept (Orencia®).
- Corticosteroid therapy at doses higher than the equivalent of 10 mg prednisone per day.
- Steroid or hyaluronate injection in the target joint or receipt of an investigational agent less than four weeks prior to screening.
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 |
|---|---|---|
| tgAAC94 gene therapy vectorSingle Dose 1x10^11 DRP/mL | Genetic | 1 |
| tgAAC94 gene therapy vectorSecond dose of 1x10^11 DRP/mL tgAAC94 administered once target joint reaches predetermined criteria for re-injection (on or after Week 12) at the same concentration as initial dose. | Genetic | 1 |
| tgAAC94 placeboplacebo | Genetic | 4 |
| tgAAC94 gene therapy vectorSingle Dose 1x10^12 DRP/mL tgAAC94 | Genetic | 2 |
| tgAAC94 gene therapy vectorSecond dose of 1x10^12 DRP/mL tgAAC94 administered once target joint reaches predetermined criteria for re-injection (on or after Week 12) at the same concentration as initial dose. | Genetic | 2 |
| tgAAC94 gene therapy vectorSingle Dose 1x10^13 DRP/mL tgAAC94 | Genetic | 3 |
| tgAAC94 gene therapy vectorSecond dose of 1x10^13 DRP/mL tgAAC94 administered once target joint reaches predetermined criteria for re-injection (on or after Week 12) at the same concentration as initial dose. | Genetic | 3 |
Primary outcome
Serious adverse events
Time frame: From time of study drug administration through final study visit
Severe or very severe adverse events
Time frame: From time of study drug administration through final study visit
Study-drug related adverse events
Time frame: From time of study drug administration through final study visit
6 secondary outcomes
Change in tenderness and swelling of target joint
Time frame: All scheduled study visits
Time to qualifying for second injection of study drug
Time frame: Week A12 or 18 or 24
Reduction in disease activity, as measured by American College of Rheumatology (ACR) criteria, Disease Activity Score (DAS) or Assessments in Ankylosing Spondylitis (ASAS) criteria, as applicable
Time frame: Day A0, Weeks A4, 8, 12, 18, 24, Day B0, Weeks B4, B8, B12, B18, B24, B30, withdrawal
Human tumor necrosis factor receptor (TNFR)-immunoglobulin (IgG1) Fc fusion (TNFR:Fc) protein levels in synovial fluid and serum
Time frame: Serum: Days A0,7,Weeks A4,12,24, Days B0,7,Weeks 8,12,18,24,30, withdrawal. Synovium: Days A0,4,Weeks A12,24, Day B0,Weeks 4,12,24, withdrawal
Serum anti-adeno-associated virus serotype 2 (AAV2) capsid neutralizing antibodies
Time frame: Day A0, Weeks A4, 12, 24, Day B0, Weeks B4, 12,24, 30, withdrawal
Joint inflammation and damage on MRI scan
Time frame: Day A0, Weeks A4, 12, 24
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 29 Jul 2009.
- Derived from this study: PubMed 20231202Heald AE, Fudman EJ, Anklesaria P, Mease PJ; 13G01 Study Team. Single-joint outcome measures: preliminary validation of patient-reported outcomes and physical examination. J Rheumatol. 2010 May;37(5):1042-8. doi: 10.3899/jrheum.090827. Epub 2010 Mar 15.
- Derived from this study: PubMed 19587341Frank KM, Hogarth DK, Miller JL, Mandal S, Mease PJ, Samulski RJ, Weisgerber GA, Hart J. Investigation of the cause of death in a gene-therapy trial. N Engl J Med. 2009 Jul 9;361(2):161-9. doi: 10.1056/NEJMoa0801066.
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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.
Alison Heald, MD study director
Targeted Genetics Corporation
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing tgAAC94 gene therapy vector in people with Arthritis, Rheumatoid and Arthritis, Psoriatic, run by Targeted Genetics Corporation at 22 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 7 inclusion and 13 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 29 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Serious adverse events (time frame: From time of study drug administration through final study visit). The study lists 3 primary outcomes in all. 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 NCT00126724, which also lists 2 linked publications.
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 29 Jul 2009.