Clostridium InfectionsPhase 2NCT00350298
Study of the Clinical Effectiveness of a Human Monoclonal Antibody to C. Difficile Toxin A and Toxin B in Patients With Clostridium Difficile Associated Disease
A Phase 2 study testing GS-CDA1/MDX-1388 and normal saline in people with Clostridium Infections, run by MassBiologics at 29 sites in 2 countries.
Trial summary
Patients with Clostridium difficile associated disease who fulfill the eligibility criteria will be approached to participate. All study patients must receive standard of care treatment for Clostridium difficile associated disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Infections
- What is being tested?
- GS-CDA1/MDX-1388 and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 29 sitesin 2 countries
- Study dates
- 20 Jul 2006to 25 Jun 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient > 18 years of age with diarrhea associated with a positive stool test for C. difficile toxin(s). Patients may be diagnosed with C. difficile by hospital/clinic/reference microbiology laboratory test or by a rapid diagnostic test performed by the study staff and positive test result must be within 14 days of enrollment.
- Patient must receive standard of care treatment for C. difficile associated disease. Standard of care treatment should include either metronidazole by mouth or intravenously or vancomycin by mouth.
- Patient or legal representative must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained.
Who cannot join
- History of chronic diarrheal illness such as ulcerative colitis or Crohn's disease.
- Score of 4 on modified Horn's index
- Severe C. difficile colitis with planned surgery in less than 24 hours.
- Positive pregnancy test within 24 hours of study infusion or an unwillingness to undergo pregnancy testing in females of child-bearing potential. Females capable of child-bearing must agree not to become pregnant from the time of study enrollment until at least 3 months after completion of study infusion. If a woman is sexually active and has no history of hysterectomy or tubal ligation, she must agree to use hormonal or barrier birth control with spermicidal gel.
- Breastfeeding.
- Receipt of other investigational study agent within previous 30 days.
- Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the patient participating in the study or make it unlikely the patient could complete the study.
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
United States22 sites
Summa Health System
Akron, Ohio, 44304
Central Indiana Gastroenterology Group
Anderson, Indiana, 46016
Saint James Healthcare
Butte, Montana, 59701
Remington-Davis Clinical Research
Columbus, Ohio, 43214
Chest, Infectious Diseases and Critical Care Assoc., PC
Des Moines, Iowa, 50325
St. Lukes Episcopal Hospital
Houston, Texas, 77030
Idaho Falls Infectious Diseases, PLLC
Idaho Falls, Idaho, 83404
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
University of Kentucky Medical Center
Lexington, Kentucky, 40536
LAC/USC Medical Center
Los Angeles, California, 90033
UCLA CURE Digestive Diseases Center
Los Angeles, California, 90095
Jersey Shore University Medical Center
Neptune City, New Jersey, 07754
Mount Sinai Hospital
New York, New York, 10029
Christiana Care Health Systems
Newark, Delaware, 19718
Kaiser Permanente Vaccine Study Center
Oakland, California, 94612
Rapid City Regional Hospital
Rapid City, South Dakota, 57701
Mayo Clinic
Rochester, Minnesota, 55905
MultiCare Health System Research Services
Tacoma, Washington, 98405
Dr. Kiran C. Patel Research Institute
Tampa, Florida, 33613
Scott and White Memorial Hospital
Temple, Texas, 76508
Henry Ford Health System
West Bloomfield, Michigan, 48322
All-Trials Clinical Research, LLC
Winston-Salem, North Carolina, 27103
Canada7 sites
University of Calgary Foothills Medical Center
Calgary, Alberta, T2N 2T9
Centre de Sante et Services Sociaux de Chicoutimi
Chicoutimi, Quebec, G7H 5H6
Kingston General Hospital
Kingston, Ontario, K7L 2V7
Centre Hospitalier Regional de Trois-Rivieres
Trois-Rivières, Quebec, G8Z 3R9
Vancouver Island Health Research Centre
Victoria, British Columbia, V8R 1J8
Windsor Regional Hospital
Windsor, Ontario, N8W 1L9
Health Sciences Centre, University of Manitoba
Winnepeg, Manitoba, R3A 1R9
About this study
Official title: A Phase II Randomized, Double-Blind, Placebo-Controlled Study of the Clinical Effectiveness of a Human Monoclonal Antibody to Clostridium Difficile Toxin A (GS-CDA1) and a Human Monoclonal Antibody to Clostridium Difficile Toxin B (MDX-1388) in Patients Being Treated for Clostridium Difficile Associated Disease
Patients with Clostridium difficile associated disease who fulfill the eligibility criteria will be approached to participate. All study patients must receive standard of care treatment for Clostridium difficile associated disease. Enrolled patients will be randomized to receive a single intravenous solution of a human monoclonal antibody (huMab) to C. difficile toxin A (GS-CDA1) combined with a human monoclonal antibody to C. difficile toxin B (MDX-1388) or 0.9% sodium chloride as placebo in a 1:1 treatment allocation. Patients will be evaluated for safety and clinical outcomes through day 84 +/- 10 days. Occurrence of adverse events, use of concomitant medications, and stool output will be assessed at scheduled phone contacts and study visits. Some patients enrolled will have a subsequent visit on day 168 ± 14 days.
Read the detailed description
This study is a phase II, randomized, double-blind, placebo-controlled study in patients diagnosed with Clostridium difficile associated disease. Patients with Clostridium difficile associated disease will be identified either from stool test results or by physician referral, and those who fulfill the eligibility criteria will be approached to participate. All study patients must receive standard of care treatment for Clostridium difficile associated disease. Enrolled patients will be randomized to receive a single intravenous solution of a human monoclonal antibody to C. difficile toxin A (GS-CDA1) combined with a human monoclonal antibody to C. difficile toxin B (MDX-1388) or 0.9% sodium chloride as placebo in a 1:1 treatment allocation. One hundred patients will be enrolled in the combination monoclonal antibody treated arm and 100 patients will be enrolled in the placebo arm. Patients will be evaluated through day 84 ± 10 days after receipt of study infusion for safety and clinical outcomes. Blood samples for safety analyses, anti-toxin A and anti-toxin B antibody measurements and human anti-human antibody (HAHA) titers will be collected at scheduled times. Study visits will occur on days 3 ± 1, 10 ± 2, 28 ± 3, 56 ± 7 and on day 84 ± 10 days. Occurrence of adverse events, use of concomitant medications, and record of stool output will be assessed at scheduled phone contacts and study visits. The first 20 patients enrolled will have a subsequent visit on day 168 ± 14 days for an additional blood collection for HAHA analysis.
- Conditions
- Clostridium Infections
- Being tested
- GS-CDA1/MDX-1388, normal saline
- Keywords
- Monoclonal antibody,, Clostridium difficile Associated Diarrhea
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-CDA1/MDX-1388Biological
One Intravenous dose
normal salineBiological
One Intravenous dose
| Study group | Role | What they receive |
|---|---|---|
| GS-CDA1/MDX-1388 | Experimental | Biological: GS-CDA1/MDX-1388 One Intravenous dose Receives: Biological: GS-CDA1/MDX-1388 |
| Placebo | Placebo comparator | Biological: normal saline (0.9% sodium chloride) One Intravenous dose Receives: Biological: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Recurrence of Clostridium Difficile Associated Disease (CDAD)
Determine if the addition of C. difficile toxin A and toxin B human monoclonal anti-toxin antibodies to standard of care treatment reduces the number of subjects with recurrent CDAD compared to standard of care and placebo. Standard of care treatment is defined as receipt of either metronidazole by mouth or parenterally or receipt of vancomycin by mouth with a standard duration of treatment defined as 10 - 14 days (+ 2 days)). Recurrence of CDAD is defined as the development of a new episode of C. difficile disease associated with a positive C. difficile stool toxin(s) test after the resolution of prior episode and after discontinuation of SOC treatment.
Measured: Day 0 to Day 84
Secondary outcomes (5)
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported
Safety and tolerability of a C. difficile toxin A human monoclonal antibody combined with a human monoclonal antibody to C. difficile toxin B in patients receiving standard of care treatment for C. difficile associated disease (CDAD) compared to those patients receiving standard of care and placebo reporting system organ class (SOC) MedDRA V.9.0
Measured: Day 0 to Day 84
Time to Resolution of Initial CDAD Episode
Determine if the addition of a C. difficile toxin A human monoclonal antibody combined with C. difficile toxin B human monoclonal antibody to standard of care treatment reduces the time to resolution of diarrhea in patients with CDAD compared to those patients receiving standard of care and placebo. Resolution of CDAD is defined as the cessation of diarrhea for at least two consecutive days.
Measured: Day 0 to Day 84
Number of Patients With Standard of Care Treatment Failure
Determine if the addition of a C. difficile toxin A human monoclonal antibody combined with C. difficile toxin B human monoclonal antibody to standard of care treatment reduces the number of patients who experience standard of care treatment failure compared to those patients receiving standard of care and placebo. Standard of care treatment failure is defined as (i) recurrence of diarrhea (after it had initially resolved) while on SOC treatment during the first 14 days, or (ii) change in SOC treatment (i.e., antibiotics given), or (iii) diarrhea episode lasting ≥14 days while on SOC treatment.
Measured: Day 0 to Day 84
Number of Patients With Severe Initial C. Difficile Disease
Determine if the addition of a C. difficile toxin A human monoclonal antibody combined with C. difficile toxin B human monoclonal antibody to standard of care treatment reduces the number of patients with severe C. difficile disease compared to those patients receiving standard of care and placebo. Severe initial disease is defined as ≥ 5 unformed stools/day for 2 consecutive days from day 1 to the end of the initial episode of diarrhea and discontinuation of SOC.
Measured: Day 0 to Day 84
Antibody Concentrations to Toxin A and to Toxin B Between Treatment Groups
Antibody concentrations to Toxin A and to Toxin B in those patients receiving C. difficile toxin A human monoclonal antibody combined with C. difficile toxin B human monoclonal antibody and standard of care treatment to those patients receiving standard of care and placebo
Measured: Day 0 to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study start20 Jul 2006
- Primary completion25 Jun 2008
- Study completion25 Jun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Clostridium InfectionsStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- MassBiologics
- Sponsor type
- University, hospital or other
- Collaborators
- Medarex
- Responsible party
- Sponsor
- Investigators
- Roger Baxter, MD, Principal investigator, Kaiser PermanenteHerbert DuPont, MD, Principal investigator, St. Lukes Episcopal Hospital, Houston, TXJoseph White, MD, Principal investigator, Scott and White Memorial Hospital, Temple, TXDavid Chen, MD, Principal investigator, MultiCare Health System Research Services, Tacoma, WAJorge Reyno, MD, Principal investigator, Rapid City Regional Hospital, Rapid City, SDHenry S. Sacks, MD, PhD, Principal investigator, Mount Sinai Hospital, New York, NYCharles N. Bernstein, MD, Principal investigator, University of Manitoba, Health Sciences Centre, Winnepeg, Manitoba, CanadaMichael J. Tan, MD, Principal investigator, Summa Health Systems, Akron, Ohio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350298
- Sponsor's protocol ID
- CA-GCDX-06-02
- Status last verified
- Jan 2021
- First submitted
- 7 Jul 2006
- Last updated
- 9 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Montgomery DL, Matthews RP, Yee KL, Tobias LM, Dorr MB, Wrishko RE. Assessment of Bezlotoxumab Immunogenicity. Clin Pharmacol Drug Dev. 2020 Apr;9(3):330-340. doi: 10.1002/cpdd.729. Epub 2019 Aug 14.
PubMed 31411386Gupta SB, Mehta V, Dubberke ER, Zhao X, Dorr MB, Guris D, Molrine D, Leney M, Miller M, Dupin M, Mast TC. Antibodies to Toxin B Are Protective Against Clostridium difficile Infection Recurrence. Clin Infect Dis. 2016 Sep 15;63(6):730-734. doi: 10.1093/cid/ciw364. Epub 2016 Jun 30.
PubMed 27365387Lowy I, Molrine DC, Leav BA, Blair BM, Baxter R, Gerding DN, Nichol G, Thomas WD Jr, Leney M, Sloan S, Hay CA, Ambrosino DM. Treatment with monoclonal antibodies against Clostridium difficile toxins. N Engl J Med. 2010 Jan 21;362(3):197-205. doi: 10.1056/NEJMoa0907635.
PubMed 20089970
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double-Blind, Placebo-Controlled Study of the Clinical Effectiveness of a Human Monoclonal Antibody to Clostridium Difficile Toxin A (GS-CDA1) and a Human Monoclonal Antibody to Clostridium Difficile Toxin B (MDX-1388) in Patients Being Treated for Clostridium Difficile Associated Disease
- ClinicalTrials.gov ID
- NCT00350298
- Acronym / sponsor ID
- CA-GCDX-06-02
- Conditions
- Clostridium Infections
- Keywords
- Monoclonal antibody,, Clostridium difficile Associated Diarrhea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- MassBiologicsUniversity, hospital or other
- Collaborators
- Medarex
- Study start
- 20 Jul 2006 (actual)
- Primary completion
- 25 Jun 2008 (actual)
- Study completion
- 25 Jun 2008 (actual)
- First posted
- 10 Jul 2006 (estimated)
- Results
- Posted 9 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with Clostridium difficile associated disease who fulfill the eligibility criteria will be approached to participate. All study patients must receive standard of care treatment for Clostridium difficile associated disease. Enrolled patients will be randomized to receive a single intravenous solution of a human monoclonal antibody (huMab) to C. difficile toxin A (GS-CDA1) combined with a human monoclonal antibody to C. difficile toxin B (MDX-1388) or 0.9% sodium chloride as placebo in a 1:1 treatment allocation. Patients will be evaluated for safety and clinical outcomes through day 84 +/- 10 days. Occurrence of adverse events, use of concomitant medications, and stool output will be assessed at scheduled phone contacts and study visits. Some patients enrolled will have a subsequent visit on day 168 ± 14 days.
Detailed description
This study is a phase II, randomized, double-blind, placebo-controlled study in patients diagnosed with Clostridium difficile associated disease. Patients with Clostridium difficile associated disease will be identified either from stool test results or by physician referral, and those who fulfill the eligibility criteria will be approached to participate. All study patients must receive standard of care treatment for Clostridium difficile associated disease. Enrolled patients will be randomized to receive a single intravenous solution of a human monoclonal antibody to C. difficile toxin A (GS-CDA1) combined with a human monoclonal antibody to C. difficile toxin B (MDX-1388) or 0.9% sodium chloride as placebo in a 1:1 treatment allocation. One hundred patients will be enrolled in the combination monoclonal antibody treated arm and 100 patients will be enrolled in the placebo arm. Patients will be evaluated through day 84 ± 10 days after receipt of study infusion for safety and clinical outcomes. Blood samples for safety analyses, anti-toxin A and anti-toxin B antibody measurements and human anti-human antibody (HAHA) titers will be collected at scheduled times. Study visits will occur on days 3 ± 1, 10 ± 2, 28 ± 3, 56 ± 7 and on day 84 ± 10 days. Occurrence of adverse events, use of concomitant medications, and record of stool output will be assessed at scheduled phone contacts and study visits. The first 20 patients enrolled will have a subsequent visit on day 168 ± 14 days for an additional blood collection for HAHA analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GS-CDA1/MDX-1388 | Experimental | Biological: GS-CDA1/MDX-1388Biological: GS-CDA1/MDX-1388 One Intravenous dose |
| Placebo | Placebo comparator | Biological: normal salineBiological: normal saline (0.9% sodium chloride) One Intravenous dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient > 18 years of age with diarrhea associated with a positive stool test for C. difficile toxin(s). Patients may be diagnosed with C. difficile by hospital/clinic/reference microbiology laboratory test or by a rapid diagnostic test performed by the study staff and positive test result must be within 14 days of enrollment.
- Patient must receive standard of care treatment for C. difficile associated disease. Standard of care treatment should include either metronidazole by mouth or intravenously or vancomycin by mouth.
- Patient or legal representative must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained.
Key exclusion criteria (7 listed)
- History of chronic diarrheal illness such as ulcerative colitis or Crohn's disease.
- Score of 4 on modified Horn's index
- Severe C. difficile colitis with planned surgery in less than 24 hours.
- Positive pregnancy test within 24 hours of study infusion or an unwillingness to undergo pregnancy testing in females of child-bearing potential. Females capable of child-bearing must agree not to become pregnant from the time of study enrollment until at least 3 months after completion of study infusion. If a woman is sexually active and has no history of hysterectomy or tubal ligation, she must agree to use hormonal or barrier birth control with spermicidal gel.
- Breastfeeding.
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 |
|---|---|---|
| GS-CDA1/MDX-1388One Intravenous dose | Biological | GS-CDA1/MDX-1388 |
| normal salineOne Intravenous dose | Biological | Placebo |
Primary outcome
Number of Participants With Recurrence of Clostridium Difficile Associated Disease (CDAD)
Time frame: Day 0 to Day 84
Determine if the addition of C. difficile toxin A and toxin B human monoclonal anti-toxin antibodies to standard of care treatment reduces the number of subjects with recurrent CDAD compared to standard of care and placebo. Standard of care treatment is defined as receipt of either metronidazole by mouth or parenterally or receipt of vancomycin by mouth with a standard duration of treatment defined as 10 - 14 days (+ 2 days)). Recurrence of CDAD is defined as the development of a new episode of C. difficile disease associated with a positive C. difficile stool toxin(s) test after the resolution of prior episode and after discontinuation of SOC treatment.
5 secondary outcomes
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported
Time frame: Day 0 to Day 84
Time to Resolution of Initial CDAD Episode
Time frame: Day 0 to Day 84
Number of Patients With Standard of Care Treatment Failure
Time frame: Day 0 to Day 84
Number of Patients With Severe Initial C. Difficile Disease
Time frame: Day 0 to Day 84
Antibody Concentrations to Toxin A and to Toxin B Between Treatment Groups
Time frame: Day 0 to Day 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31411386Montgomery DL, Matthews RP, Yee KL, Tobias LM, Dorr MB, Wrishko RE. Assessment of Bezlotoxumab Immunogenicity. Clin Pharmacol Drug Dev. 2020 Apr;9(3):330-340. doi: 10.1002/cpdd.729. Epub 2019 Aug 14.
- Derived from this study: PubMed 27365387Gupta SB, Mehta V, Dubberke ER, Zhao X, Dorr MB, Guris D, Molrine D, Leney M, Miller M, Dupin M, Mast TC. Antibodies to Toxin B Are Protective Against Clostridium difficile Infection Recurrence. Clin Infect Dis. 2016 Sep 15;63(6):730-734. doi: 10.1093/cid/ciw364. Epub 2016 Jun 30.
- Derived from this study: PubMed 20089970Lowy I, Molrine DC, Leav BA, Blair BM, Baxter R, Gerding DN, Nichol G, Thomas WD Jr, Leney M, Sloan S, Hay CA, Ambrosino DM. Treatment with monoclonal antibodies against Clostridium difficile toxins. N Engl J Med. 2010 Jan 21;362(3):197-205. doi: 10.1056/NEJMoa0907635.
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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.
Roger Baxter, MD principal investigator
Kaiser Permanente
Herbert DuPont, MD principal investigator
St. Lukes Episcopal Hospital, Houston, TX
Joseph White, MD principal investigator
Scott and White Memorial Hospital, Temple, TX
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GS-CDA1/MDX-1388 and normal saline in people with Clostridium Infections, run by MassBiologics at 29 sites in 2 countries.
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 3 inclusion and 7 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 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Canada. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Recurrence of Clostridium Difficile Associated Disease (CDAD) (time frame: Day 0 to Day 84). 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 NCT00350298, which also lists 3 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 9 Feb 2021.