Heart TransplantationPhase 2NCT03292861
The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients
A Phase 2 study testing Thymoglobulin, Mycophenolate Mofetil and Tacrolimus in people with Heart Transplantation, run by Cedars-Sinai Medical Center at 2 sites in United States.
Trial summary
This is a randomized, controlled, single center study to evaluate the efficacy of Thymoglobulin induction therapy in combination with Mycophenolate Mofetil, tacrolimus, and steroids in the prevention of CAV. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Heart Transplantation
- What is being tested?
- Thymoglobulin, Mycophenolate Mofetil and Tacrolimus
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Sep 2018to 31 Mar 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be undergoing their first allograft transplant
- Men and non-pregnant women must be 18 to 70 years old
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to transplantation. The sensitivity must be equal to at least 50 mIU/mL. (Urine test is allowed in addition to serum test in patients where serum results are delayed)
- Men with a female partner of child bearing age and women of childbearing potential must use two reliable forms of contraception simultaneously. Effective contraception must be used before beginning study drug therapy, and for 4 months following discontinuation of study drug therapy.
- Subjects must be willing and capable of understanding the purpose and risks of the study, and must sign a statement of informed consent
- Subjects with a Creatinine < 2.0 mg/dl at time of transplant
Who cannot join
- Allergy to Thymoglobulin-Thymoglobulin is contraindicated in patients with history of allergy or anaphylaxis to rabbit proteins or to any product excipients, or who have active acute or chronic infections which contraindicate any additional immunosuppression
- Previous organ transplants
- Patients receiving multiple organs
- Patients with a BMI higher than 35
- Patients with PRA ≥ 25%
- Patients requiring VAD upon completion of transplantation surgery.
Show all 12Show fewer
- HIV-1, HTLV-1, chronic Hepatitis B, or chronic Hepatitis C infection
- Documented or strong suspicion for pre-operative active infection that has not yet been adequately treated with the recommended course of antimicrobial therapy
- Presence of any chronic myelosuppressive disease or agent that has resulted in either chronic leucopenia or chronic thrombocytopenia
- Active peptic ulcer disease and active GI bleeding
- Patients who have received within the past 30 days or require concomitant treatment with other investigational drugs (except for those listed in section 8.6 "Concomitant treatment")
- Patients with a history of AL amyloidosis (TTR amyloids) are permitted
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: A Pilot Randomized Study to Assess the Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients: A 12-month, Single Center, Randomized, Open-label Study of Efficacy Comparing Immediate Treatment With and Without Thymoglobulin® 1.5 mg/kg/d for 5 Consecutive Days in Heart Transplant Recipients
This is a randomized, controlled, single center study to evaluate the efficacy of Thymoglobulin induction therapy in combination with Mycophenolate Mofetil, tacrolimus, and steroids in the prevention of CAV. Approximately half of the patients will be randomized to receive a total of 5 doses of Thymoglobulin during the study. The first dose of Thymoglobulin will be administered at 1.5 mg/kg via intravenous infusion over 6 hours immediately upon arrival to the ICU post-operation (day 1). Subsequent doses of 1.5 mg/kg will be administered on days 2, 3, 4, and 5 via IV infusion over 4 hours.
Mechanistic assays (T-reg cells, Lym subsets, B cell subsets, IL-1b, cytokines, TGFb, IL-21 to be drawn at Pre-transplant, 3, 6, 12 months post-transplant) will also be performed.
All patients will be followed and monitored according to standard of care protocols for heart transplant recipients at our center.
- Conditions
- Heart Transplantation
- Being tested
- Thymoglobulin, Mycophenolate Mofetil, Tacrolimus, Sirolimus, Corticosteroids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThymoglobulinDrug
Approximately half of the patients will be randomized to receive a total of 5 doses of Thymoglobulin during the study. The first dose of Thymoglobulin will be administered at 1.5 mg/kg via intravenous infusion over 8 hours immediately upon arrival to the ICU post-operation (day 1). Subsequent doses of 1.5 mg/kg will be administered on days 2, 3, 4, and 5 via IV infusion over 4-8 hours.
3.0 grams divided bid begun post-transplant, either IV or po as tolerated by patient. Initial dose must be given within 24 hours post-transplant. Dosing will be titrated based on recipient's body size and any adverse side effects
TacrolimusDrug
Doses of 1-4 mg bid either IV or po will be prescribed to achieve a target trough level of 10-15 ng/mL before post-operative day number 5. Target trough levels are 10-15 ng/mL for post-operative days #1-30, 8-12ng/mL days#31-60 and 5-10 ng/mL thereafter.
SirolimusDrug
Maintenance doses of sirolimus at 12 months post-transplantation
CorticosteroidsDrug
125 mg IV methylprednisolone immediately post-operatively x 3 doses q12hrs, then switching to oral prednisone at 1.0 mg/kg/day po divided into bid doses that are rounded off to the next higher 5 mg increment. For example, a 76 kg person would should be dosed at 38 mg po bid, which rounded off to the next 5 mg increment would be 40 mg po bid. (Equivalent dosing via an alternative route may be used if pos not tolerated or contraindicated). Prednisone will be tapered by 10 mg qd until the dose of 10 mg po bid is reached.
| Study group | Role | What they receive |
|---|---|---|
| Thymoglobulin® | Active comparator | Thymoglobulin® (Genzyme) [rabbit anti-thymocyte globulin (ATG)] is a purified pasteurized, gamma immune globulin, obtained by immunization of rabbits with human thymocytes. This immunosuppressive product contains polyclonal cytotoxic antibodies directed against antigens expressed on human T-lymphocytes. Approximately half of the patients will be randomized to receive a total of 5 doses of Thymoglobulin during the study. The first dose of Thymoglobulin will be administered at 1.5 mg/kg via intravenous infusion over 6 hours immediately upon arrival to the ICU post-operation (day 1). Subsequent doses of 1.5 mg/kg will be administered on days 2, 3, 4, and 5 via IV infusion over 4 hours.
In addition, there will be maintenance doses of mycophenolate mofetil, tacrolimus, sirolimus, and cumulative dose of corticosteroids at 12 months post-transplantation Receives: Drug: Thymoglobulin; Drug: Mycophenolate Mofetil; Drug: Tacrolimus; Drug: Sirolimus; Drug: Corticosteroids |
| No induction therapy | No intervention | Patients qualifying for the study will be randomized before the transplantation surgery in a 1:1 ratio to either Thymoglobulin® or no treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Composite Efficacy Failure at 12 Months
Composite efficacy failure is defined as development of de novo donor specific antibodies (measured by standardized alloantibody testing by Luminex and control sera, characterizing kinetics, specificities and relative binding strength) and ischemia on endomyocardial biopsy (characterized on biopsy by myocyte necrosis and/or regions of myocyte dropout) at 12 months post-transplant.
Measured: 12 Months
Secondary outcomes (29)
Changes in immune cell profiles
Correlations between significant changes in immune cell profiles and biomarkers, and their relation to any significant differences in clinical outcomes
Measured: 12 months
Changes in biomarkers
Correlations between significant changes in biomarkers and their relation to any significant differences in clinical outcomes
Measured: 12 months
Number of patients who experience rejection
Number of patients who experience acute cellular, antibody-mediated, hemodynamic compromise, and any-treated rejection within first 12 months after transplantation/
Measured: 12 months
Number of episodes per patient
Number of acute cellular, antibody-mediated, hemodynamic compromise and any-treated rejection episodes per patient within the first 12 months post-transplantation
Measured: 12 months
First rejection by ISHLT biopsy grading scale
First acute cellular, antibody-mediated, hemodynamic compromise, and any-treated rejection by the ISHLT biopsy grading scale in the first 12 months post-transplantation
Measured: 12 months
Time to first rejection
Time to first acute cellular, antibody-mediated, hemodynamic compromise, and any-treated rejection within the first 12 months
Measured: 12 months
Incidence of primary graft dysfunction (PGD)
The incidence of Primary Graft Dysfunction(PGD) in the first 24 hours post-transplant
Measured: first 24 hours post-transplant
Patient and graft survival
Patient and graft survival at 12 months post-transplantation
Measured: 12 months
Types of patients with fatal infectious complications
The types of patients with fatal infectious complications (especially CMV infection) within the first 12 months post-transplantation
Measured: 12 months
Number of patients with fatal infectious complications
The number of patients with fatal infectious complications (especially CMV infection) within the first 12 months post-transplantation
Measured: 12 months
Types of patients with non-fatal infectious complications
Types of patients with non-fatal infectious complications (especially CMV infection) within the first 12 months post-transplantation
Measured: 12 months
Number of patients with non-fatal infectious complications
Number of patients with non-fatal infectious complications (especially CMV infection) within the first 12 months post-transplantation
Measured: 12 months
Freedom from development of circulating antibodies
Freedom from the development of circulating antibodies within the first 12 months post transplantation, where circulating antibodies include donor specific antibodies (DSA), non-specific antibodies, and non-human leukocyte antigen antibodies
Measured: 12 months
Change in coronary maximal intimal thickness
Change in coronary maximal intimal thickness at matched sites by intravascular ultrasound at 12 months
Measured: 12 months
Change in coronary intimal area
Change in coronary intimal area at matched sites by intravascular ultrasound at 12 months
Measured: 12 months
Change in coronary intimal volume
Change in coronary intimal volume at matched sites by intravascular ultrasound at 12 months
Measured: 12 months
Change in coronary vessel area
Change in coronary vessel area at matched sites by intravascular ultrasound at 12 months
Measured: 12 months
Change in coronary intimal index
Change in coronary intimal index at matched sites by intravascular ultrasound at 12 months
Measured: 12 months
Change in coronary percent atheroma volume
Change in coronary percent atheroma volume at matched sites by intravascular ultrasound at 12 months
Measured: 12 months
Maintenance doses of mycophenolate mofetil, tacrolimus, sirolimus, and dose of corticosteroids
Maintenance doses of mycophenolate mofetil, tacrolimus, sirolimus, and cumulative dose of corticosteroids at 12 months post-transplantation
Measured: 12 months
Number of hospital days per patient
Number of hospital days per patient, both during the transplant period and during the post-transplant period at 3 months, 6 months, and 1 year
Measured: 3 months, 6 months, 12 months
Number of patients requiring hospitalization
Number of patients requiring hospitalization by 3 months, by 6 months, or by 1 year post-transplantation
Measured: 3 months, 6 months, 12 months
Death/Re-transplant
To describe between treatment groups the incidence of the composite primary endpoint of death/re-transplant at 12 months post-transplantation
Measured: 12 months
Hemodynamic compromise rejection
To describe between treatment groups the incidence of the composite primary endpoint of hemodynamic compromise rejection at 12 months post-transplantation. This is an ejection fraction of ≤ 30% or a 0.20 absolute decrease from baseline, and the need for inotropic agents OR a fractional shortening ≤ 20% or a 25% decrease from baseline, and the need for inotropic agents PLUS need for inotropic agents due to a Cardiac Index (CI) < 2.0 L/min/m2 or a 25% decrease from baseline
Measured: 12 months
Graft dysfunction
To describe between treatment groups the incidence of the composite primary endpoint of graft dysfunction (ejection fraction less than or equal to 40% by echocardiography)at 12 months post-transplantation
Measured: 12 months
Cellular rejection
To describe between treatment groups the incidence of the composite primary endpoint of biopsy proven cellular rejection ≥2R at 12 months post-transplantation
Measured: 12 months
Antibody mediated rejected
To describe between treatment groups the incidence of the composite primary endpoint of biopsy proven antibody mediated rejection ≥AMR1 at 12 months post-transplantation
Measured: 12 months
Cardiac Allograft Vasculopathy (CAV)
To describe between treatment groups the incidence of cardiac allograft vasculopathy (CAV) (defined as a change ≥0.5mm in maximal intimal thickness (MIT) of the coronary arteries by intravascular ultrasound at 12 months as compared to baseline)
Measured: 12 months
Any treated rejection
To describe between treatment groups any treated rejection at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start13 Sep 2018
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantationStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Principal investigator, Jon Kobashigawa, Cedars-Sinai Medical Center
- Investigators
- Jon Kobashigawa, MD, Principal investigator, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292861
- Sponsor's protocol ID
- ATG Pilot Study
- Status last verified
- Jan 2026
- First submitted
- 12 Sep 2017
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Study to Assess the Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients: A 12-month, Single Center, Randomized, Open-label Study of Efficacy Comparing Immediate Treatment With and Without Thymoglobulin® 1.5 mg/kg/d for 5 Consecutive Days in Heart Transplant Recipients
- ClinicalTrials.gov ID
- NCT03292861
- Acronym / sponsor ID
- ATG Pilot Study
- Conditions
- Heart Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 26 Sep 2017 (actual)
- 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.
This is a randomized, controlled, single center study to evaluate the efficacy of Thymoglobulin induction therapy in combination with Mycophenolate Mofetil, tacrolimus, and steroids in the prevention of CAV. Approximately half of the patients will be randomized to receive a total of 5 doses of Thymoglobulin during the study. The first dose of Thymoglobulin will be administered at 1.5 mg/kg via intravenous infusion over 6 hours immediately upon arrival to the ICU post-operation (day 1). Subsequent doses of 1.5 mg/kg will be administered on days 2, 3, 4, and 5 via IV infusion over 4 hours.
Mechanistic assays (T-reg cells, Lym subsets, B cell subsets, IL-1b, cytokines, TGFb, IL-21 to be drawn at Pre-transplant, 3, 6, 12 months post-transplant) will also be performed.
All patients will be followed and monitored according to standard of care protocols for heart transplant recipients at our center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thymoglobulin® | Active comparator | Drug: Thymoglobulin, Drug: Mycophenolate Mofetil, Drug: Tacrolimus, Drug: Sirolimus, Drug: CorticosteroidsThymoglobulin® (Genzyme) [rabbit anti-thymocyte globulin (ATG)] is a purified pasteurized, gamma immune globulin, obtained by immunization of rabbits with human thymocytes. This immunosuppressive product contains polyclonal cytotoxic antibodies directed against antigens expressed on human T-lymphocytes. Approximately half of the patients will be randomized to receive a total of 5 doses of Thymoglobulin during the study. The first dose of Thymoglobulin will be administered at 1.5 mg/kg via intravenous infusion over 6 hours immediately upon arrival to the ICU post-operation (day 1). Subsequent doses of 1.5 mg/kg will be administered on days 2, 3, 4, and 5 via IV infusion over 4 hours. In addition, there will be maintenance doses of mycophenolate mofetil, tacrolimus, sirolimus, and cumulative dose of corticosteroids at 12 months post-transplantation |
| No induction therapy | No intervention | –Patients qualifying for the study will be randomized before the transplantation surgery in a 1:1 ratio to either Thymoglobulin® or no treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must be undergoing their first allograft transplant
- Men and non-pregnant women must be 18 to 70 years old
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to transplantation. The sensitivity must be equal to at least 50 mIU/mL. (Urine test is allowed in addition to serum test in patients where serum results are delayed)
- Men with a female partner of child bearing age and women of childbearing potential must use two reliable forms of contraception simultaneously. Effective contraception must be used before beginning study drug therapy, and for 4 months following discontinuation of study drug therapy.
- Subjects must be willing and capable of understanding the purpose and risks of the study, and must sign a statement of informed consent
Key exclusion criteria (12 listed)
- Allergy to Thymoglobulin-Thymoglobulin is contraindicated in patients with history of allergy or anaphylaxis to rabbit proteins or to any product excipients, or who have active acute or chronic infections which contraindicate any additional immunosuppression
- Previous organ transplants
- Patients receiving multiple organs
- Patients with a BMI higher than 35
- Patients with PRA ≥ 25%
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 |
|---|---|---|
| ThymoglobulinApproximately half of the patients will be randomized to receive a total of 5 doses of Thymoglobulin during the study. The first dose of Thymoglobulin will be administered at 1.5 mg/kg via intravenous infusion over 8 hours immediately upon arrival to the ICU post-operation (day 1). Subsequent doses of 1.5 mg/kg will be administered on days 2, 3, 4, and 5 via IV infusion over 4-8 hours. | Drug | Thymoglobulin® |
| Mycophenolate Mofetil3.0 grams divided bid begun post-transplant, either IV or po as tolerated by patient. Initial dose must be given within 24 hours post-transplant. Dosing will be titrated based on recipient's body size and any adverse side effects | Drug | Thymoglobulin® |
| TacrolimusDoses of 1-4 mg bid either IV or po will be prescribed to achieve a target trough level of 10-15 ng/mL before post-operative day number 5. Target trough levels are 10-15 ng/mL for post-operative days #1-30, 8-12ng/mL days#31-60 and 5-10 ng/mL thereafter. | Drug | Thymoglobulin® |
| SirolimusMaintenance doses of sirolimus at 12 months post-transplantation | Drug | Thymoglobulin® |
| Corticosteroids125 mg IV methylprednisolone immediately post-operatively x 3 doses q12hrs, then switching to oral prednisone at 1.0 mg/kg/day po divided into bid doses that are rounded off to the next higher 5 mg increment. For example, a 76 kg person would should be dosed at 38 mg po bid, which rounded off to the next 5 mg increment would be 40 mg po bid. (Equivalent dosing via an alternative route may be used if pos not tolerated or contraindicated). Prednisone will be tapered by 10 mg qd until the dose of 10 mg po bid is reached. | Drug | Thymoglobulin® |
Primary outcome
Percentage of Participants With Composite Efficacy Failure at 12 Months
Time frame: 12 Months
Composite efficacy failure is defined as development of de novo donor specific antibodies (measured by standardized alloantibody testing by Luminex and control sera, characterizing kinetics, specificities and relative binding strength) and ischemia on endomyocardial biopsy (characterized on biopsy by myocyte necrosis and/or regions of myocyte dropout) at 12 months post-transplant.
29 secondary outcomes
Changes in immune cell profiles
Time frame: 12 months
Changes in biomarkers
Time frame: 12 months
Number of patients who experience rejection
Time frame: 12 months
Number of episodes per patient
Time frame: 12 months
First rejection by ISHLT biopsy grading scale
Time frame: 12 months
Time to first rejection
Time frame: 12 months
Incidence of primary graft dysfunction (PGD)
Time frame: first 24 hours post-transplant
Patient and graft survival
Time frame: 12 months
Types of patients with fatal infectious complications
Time frame: 12 months
Number of patients with fatal infectious complications
Time frame: 12 months
Types of patients with non-fatal infectious complications
Time frame: 12 months
Number of patients with non-fatal infectious complications
Time frame: 12 months
Freedom from development of circulating antibodies
Time frame: 12 months
Change in coronary maximal intimal thickness
Time frame: 12 months
Change in coronary intimal area
Time frame: 12 months
Change in coronary intimal volume
Time frame: 12 months
Change in coronary vessel area
Time frame: 12 months
Change in coronary intimal index
Time frame: 12 months
Change in coronary percent atheroma volume
Time frame: 12 months
Maintenance doses of mycophenolate mofetil, tacrolimus, sirolimus, and dose of corticosteroids
Time frame: 12 months
Number of hospital days per patient
Time frame: 3 months, 6 months, 12 months
Number of patients requiring hospitalization
Time frame: 3 months, 6 months, 12 months
Death/Re-transplant
Time frame: 12 months
Hemodynamic compromise rejection
Time frame: 12 months
Graft dysfunction
Time frame: 12 months
Cellular rejection
Time frame: 12 months
Antibody mediated rejected
Time frame: 12 months
Cardiac Allograft Vasculopathy (CAV)
Time frame: 12 months
Any treated rejection
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
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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.
Jon Kobashigawa, MD principal investigator
Director
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thymoglobulin, Mycophenolate Mofetil and Tacrolimus in people with Heart Transplantation, run by Cedars-Sinai Medical Center at 2 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 6 inclusion and 12 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: enrolling by invitation, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of Participants With Composite Efficacy Failure at 12 Months (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2026.