Cytomegalovirus InfectionsPhase 4NCT01663740
A Study on Spermatogenesis in Male Renal Transplant Recipients Receiving Valganciclovir (Valcyte®) Versus Untreated Matched Controls
A Phase 4 study testing Valganciclovir in people with Cytomegalovirus Infections, run by Hoffmann-La Roche at 19 sites in 2 countries.
Trial summary
This observational study will compare spermatogenesis in male adult renal transplant recipients receiving valganciclovir versus untreated matched controls. Data will be collected from each participant for up to 52 weeks post transplant. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Cytomegalovirus Infections
- What is being tested?
- Valganciclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 30 Jan 2012to 30 Dec 2016
- Phase
- Phase 4
- 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 20 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- First renal transplant
- Participant eligible to receive valganciclovir prophylaxis as determined by the treating physician in accordance with the local approved product prescribing information (Cohort A only) or the participant is not expected to require any valganciclovir prophylaxis (Cohort B only) post-transplant
- Participant has no history of known infertility
- Participant is able and willing to provide semen samples
- Participant agrees to utilize a barrier contraceptive throughout the study or for at least 90 days after cessation of valganciclovir treatment
Who cannot join
- Prior ganciclovir or valganciclovir within 3 months of enrollment
- Organ transplant other than kidney
- Participant has received an investigational new drug in the 3 months prior to transplant
- Participant hs received an alkylating agent or other medications known to affect fertility/spermatogenesis
- Participant is unlikely to be available for follow-up for the entire duration of the study (up to 52 weeks)
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States16 sites
Albany Medical Cancer Center
Albany, New York, 12208
Medical College of Georgia
Augusta, Georgia, 30912
Tufts Medical Center
Boston, Massachusetts, 02111
University at Buffalo
Buffalo, New York, 14203
National Institute of Transplantation
Los Angeles, California, 90057
University of California Los Angeles (UCLA)
Los Angeles, California, 90095
University of Minnesota
Minneapolis, Minnesota, 55455
Drexel University Department of Nephrology
Philadelphia, Pennsylvania, 19102
Oregan Health & Science Univ
Portland, Oregon, 97237
Rhode Island Hospital
Providence, Rhode Island, 02903
Mayo Clinic Rochester
Rochester, Minnesota, 55902
Methodist Healthcare System of San Antonio
San Antonio, Texas, 78229
University of California at San Francisco
San Francisco, California, 94115
Western New England Renal & Transplant Associates, P.C.
Springfield, Massachusetts, 01107
Stony Brook University Hospital
Stony Brook, New York, 11794
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Mexico3 sites
Hospital Miguel Hidalgo
Aguascalientes, 20230
Instituto Mexicano de Trasplantes
Cuernavaca, 62448
Hospital Central Dr. Ignacio Morones Prieto
San Luis Potosí City, 78240
About this study
Official title: A Multicenter Prospective Cohort Study to Investigate if Ganciclovir Significantly Affects Spermatogenesis in Adult Male Renal Transplant Recipients Receiving up to 200 Days Valganciclovir Vs. Concurrent Untreated Matched Controls
This observational study will compare spermatogenesis in male adult renal transplant recipients receiving valganciclovir versus untreated matched controls. Data will be collected from each participant for up to 52 weeks post transplant.
- Conditions
- Cytomegalovirus Infections
- Being tested
- Valganciclovir
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValganciclovirDrug
Also called Valcyte®
Participants will receive valganciclovir 900 milligrams (mg) orally once daily for up to a maximum of 200 days post-transplant.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Partcipants who Received Valganciclovir | Experimental | Participants with donor positive (D+)/recipient negative (R-) cytomegalovirus (CMV) serology, who receive valganciclovir prophylaxis according to the local prescribing information, will be observed for spermatogenesis up to 52 weeks post-transplant. Receives: Drug: Valganciclovir |
| Cohort B: Untreated Participants | No intervention | Participants with donor negative (D-)/R- CMV serology, who do not receive prophylaxis, will be observed for spermatogenesis up to 52 weeks post-transplant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sperm Density From Baseline to the End of Treatment (EOT)
Sperm density was calculated based on the average of two semen samples. Change was calculated as the sperm density measured at post-baseline visit (EOT) minus (-) the sperm density measured at baseline for each participant. A negative change from baseline indicated a lower sperm density (worsening).
Measured: Baseline, EOT (Week 28)
Secondary outcomes (26)
Change in Terminal Uridine Nick-End Labeling (TUNEL) Score From Baseline to EOT and End of Follow-up (FU)
Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Change was calculated as the TUNEL score measured at post-baseline visit (EOT and FU) minus the TUNEL score measured at baseline for each participant. A negative change from baseline indicated a lower TUNEL score. TUNEL score represents percentage of sperm with fragmented DNA; total score ranged from 0 percent (%) to 100%, higher score represents more fragmentation.
Measured: Baseline, EOT (Week 28), end of FU (Week 52)
Change in TUNEL Score From EOT to End of FU
Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Change was calculated as the TUNEL score measured at FU minus the TUNEL score measured at EOT for each participant. A negative change from EOT indicated a lower TUNEL score. TUNEL score represents percentage of sperm with fragmented DNA; total score ranged from 0% to 100%, higher score represents more fragmentation.
Measured: EOT (Week 28), end of FU (Week 52)
Change in Seminal Volume From Baseline to EOT and End of FU
Seminal volume was calculated based on the average of two semen samples. Change was calculated as the seminal volume measured at post-baseline visit (EOT and FU) - the seminal volume measured at baseline for each participant. A negative change from baseline indicated a lower seminal volume (worsening).
Measured: Baseline, EOT (Week 28), end of FU (Week 52)
Change in Seminal Volume From EOT to End FU
Seminal volume was calculated based on the average of two semen samples. Change was calculated as the seminal volume measured at FU - the seminal volume measured at EOT for each participant. A negative change from EOT indicated a lower seminal volume (worsening).
Measured: EOT (Week 28), end of FU (Week 52)
Change in Sperm Density From EOT to End of FU
Sperm density was calculated based on the average of two semen samples. Change was calculated as the sperm density measured at FU - the sperm density measured at EOT for each participant. A negative change from EOT indicated a lower sperm density (worsening).
Measured: EOT (Week 28), end of FU (Week 52)
Change in Sperm Density From Baseline to End of FU
Sperm density was calculated based on the average of two semen samples. Change was calculated as the sperm density measured at post-baseline visit (FU) - the sperm density measured at baseline for each participant. A negative change from baseline indicated a lower sperm density (worsening).
Measured: Baseline, end of FU (Week 52)
Change in Total Motility of Sperm From Baseline to EOT and End of FU
Sperm motility was calculated based on the average of two semen samples. Percent was determined by the calculation of motile sperm/total sperm count. Change was calculated as the sperm motility measured at post-baseline visit (EOT and FU) - the sperm motility measured at baseline for each participant. A negative change from baseline indicated a lower sperm motility (worsening).
Measured: Baseline, EOT (Week 28), end of FU (Week 52)
Change in Total Motility of Sperm From EOT to End of FU
Sperm motility was calculated based on the average of two semen samples. Percent was determined by the calculation of motile sperm/total sperm count. Change was calculated as the sperm motility measured at FU - the sperm motility measured at EOT for each participant. A negative change from EOT indicated a lower sperm motility (worsening).
Measured: EOT (Week 28), end of FU (Week 52)
Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From Baseline to EOT and End of FU
Sperm morphology was evaluated based on the average of two semen samples. Change was calculated as the sperm morphology measured at post-baseline visit (EOT and FU) - the sperm morphology measured at baseline for each participant. A positive change from baseline indicated an improved sperm morphology.
Measured: Baseline, EOT (Week 28), end of FU (Week 52)
Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From EOT to End of FU
Sperm morphology was evaluated based on the average of two semen samples. Change was calculated as the sperm morphology measured at FU - the sperm morphology measured at EOT for each participant. A positive change from EOT indicated an improved sperm morphology.
Measured: EOT (Week 28), end of FU (Week 52)
Change in Total Testosterone Level From Baseline to EOT and End of FU
Testosterone level was calculated based on the average of two samples. Change was calculated as the testosterone level measured at post-baseline visit (EOT and FU) - the testosterone level measured at baseline for each participant. A negative change from baseline indicated a lower testosterone level.
Measured: Baseline, EOT (Week 28), end of FU (Week 52)
Change in Total Testosterone Level From EOT to End of FU
Testosterone level was calculated based on the average of two samples. Change was calculated as the testosterone level measured at FU - the testosterone level measured at EOT for each participant. A negative change from EOT indicated a lower testosterone level.
Measured: EOT (Week 28), end of FU (Week 52)
Change in LH Level From Baseline to EOT and End of FU
LH level was calculated based on the average of two samples. Change was calculated as the LH level measured at post-baseline visit (EOT and FU) - the LH level measured at baseline for each participant. A negative change from baseline indicated a lower LH level.
Measured: Baseline, EOT (Week 28), end of FU (Week 52)
Change in LH Level From EOT to End of FU
LH level was calculated based on the average of two samples. Change was calculated as the LH level measured at FU - the LH level measured at EOT for each participant. A negative change from EOT indicated a lower LH level.
Measured: EOT (Week 28), end of FU (Week 52)
Change in FSH Level From Baseline to EOT and End of FU
FSH level was calculated based on the average of two samples. Change was calculated as the FSH level measured at post-baseline visit (EOT and FU) - the FSH level measured at baseline for each participant. A negative change from baseline indicated a lower FSH level.
Measured: Baseline, EOT (Week 28), end of FU (Week 52)
Change in FSH Level From EOT to End of FU
FSH level was calculated based on the average of two samples. Change was calculated as the FSH level measured at FU - the FSH level measured at EOT for each participant. A negative change from EOT indicated a lower FSH level.
Measured: EOT (Week 28), end of FU (Week 52)
Change in Prolactin Level From Baseline to EOT and End of FU
Prolactin level was calculated based on the average of two samples. Change was calculated as the prolactin level measured at post-baseline visit (EOT and FU) - the prolactin level measured at baseline for each participant. A negative change from baseline indicated a lower prolactin level.
Measured: Baseline, EOT (Week 28), end of FU (Week 52)
Change in Prolactin Level From EOT to End of FU
Prolactin level was calculated based on the average of two samples. Change was calculated as the prolactin level measured at FU - the prolactin level measured at EOT for each participant. A negative change from EOT indicated a lower prolactin level.
Measured: EOT (Week 28), end of FU (Week 52)
Change in Inhibin B Level From Baseline to EOT and End of FU
Inhibin B level was calculated based on the average of two samples. Change was calculated as the inhibin B level measured at post-baseline visit (EOT and FU) - the inhibin B level measured at baseline for each participant. A negative change from baseline indicated a lower inhibin B level.
Measured: Baseline, EOT (Week 28), end of FU (Week 52)
Change in Inhibin B Level From EOT to End of FU
Inhibin B level was calculated based on the average of two samples. Change was calculated as the inhibin B level measured at FU - the inhibin B level measured at EOT for each participant. A negative change from EOT indicated a lower inhibin B level.
Measured: EOT (Week 28), end of FU (Week 52)
Percentage of Participants With Abnormal Sperm Density (<20 Mil/mL) From Baseline to EOT and End of FU
Abnormal sperm density was considered as sperm density less than (<) 20 mil/mL. Change in abnormal to abnormal sperm density and normal to abnormal sperm density from baseline to EOT and end of FU was reported.
Measured: Baseline, EOT (Week 28), end of FU (Week 52)
Percentage of Participants With Abnormal Sperm Density (<20 Mil/mL) From EOT to End of FU
Abnormal sperm density was considered as sperm density <20 mil/mL. Change in abnormal to abnormal sperm density and normal to abnormal sperm density from EOT to end of FU was reported.
Measured: EOT (Week 28), end of FU (Week 52)
Percentage of Participants With Improved TUNEL Score From Baseline to EOT and End of FU
Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Participants who had a lower TUNEL score compared to the previous time point were considered as improved.
Measured: Baseline, EOT (Week 28), end of FU (Week 52)
Percentage of Participants With Improved TUNEL Score From EOT to End of FU
Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Participants who had a lower TUNEL score compared to the previous time point were considered as improved.
Measured: EOT (Week 28), end of FU (Week 52)
Percentage of Participants With Improved Sperm Density From Baseline to EOT and End of FU
Participants who had higher sperm density compared with the previous visit were considered as improved.
Measured: Baseline, EOT (Week 28), end of FU (Week 52)
Percentage of Participants With Improved Sperm Density From EOT to End of FU
Participants who had higher sperm density compared with the previous visit were considered as improved.
Measured: EOT (Week 28), end of FU (Week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study start30 Jan 2012
- Primary completion29 Sep 2015
- Study completion30 Dec 2016
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.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663740
- Sponsor's protocol ID
- WV25651
- Status last verified
- Jul 2018
- First submitted
- 9 Aug 2012
- Last updated
- 31 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Cohort Study to Investigate if Ganciclovir Significantly Affects Spermatogenesis in Adult Male Renal Transplant Recipients Receiving up to 200 Days Valganciclovir Vs. Concurrent Untreated Matched Controls
- ClinicalTrials.gov ID
- NCT01663740
- Acronym / sponsor ID
- WV25651
- Conditions
- Cytomegalovirus Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2012 (actual)
- Primary completion
- 29 Sep 2015 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 13 Aug 2012 (estimated)
- Results
- Posted 31 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study will compare spermatogenesis in male adult renal transplant recipients receiving valganciclovir versus untreated matched controls. Data will be collected from each participant for up to 52 weeks post transplant.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Partcipants who Received Valganciclovir | Experimental | Drug: ValganciclovirParticipants with donor positive (D+)/recipient negative (R-) cytomegalovirus (CMV) serology, who receive valganciclovir prophylaxis according to the local prescribing information, will be observed for spermatogenesis up to 52 weeks post-transplant. |
| Cohort B: Untreated Participants | No intervention | –Participants with donor negative (D-)/R- CMV serology, who do not receive prophylaxis, will be observed for spermatogenesis up to 52 weeks post-transplant. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- First renal transplant
- Participant eligible to receive valganciclovir prophylaxis as determined by the treating physician in accordance with the local approved product prescribing information (Cohort A only) or the participant is not expected to require any valganciclovir prophylaxis (Cohort B only) post-transplant
- Participant has no history of known infertility
- Participant is able and willing to provide semen samples
- Participant agrees to utilize a barrier contraceptive throughout the study or for at least 90 days after cessation of valganciclovir treatment
Key exclusion criteria (5 listed)
- Prior ganciclovir or valganciclovir within 3 months of enrollment
- Organ transplant other than kidney
- Participant has received an investigational new drug in the 3 months prior to transplant
- Participant hs received an alkylating agent or other medications known to affect fertility/spermatogenesis
- Participant is unlikely to be available for follow-up for the entire duration of the study (up to 52 weeks)
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 |
|---|---|---|
| ValganciclovirAlso: Valcyte®Participants will receive valganciclovir 900 milligrams (mg) orally once daily for up to a maximum of 200 days post-transplant. | Drug | Cohort A: Partcipants who Received Valganciclovir |
Primary outcome
Change in Sperm Density From Baseline to the End of Treatment (EOT)
Time frame: Baseline, EOT (Week 28)
Sperm density was calculated based on the average of two semen samples. Change was calculated as the sperm density measured at post-baseline visit (EOT) minus (-) the sperm density measured at baseline for each participant. A negative change from baseline indicated a lower sperm density (worsening).
26 secondary outcomes
Change in Terminal Uridine Nick-End Labeling (TUNEL) Score From Baseline to EOT and End of Follow-up (FU)
Time frame: Baseline, EOT (Week 28), end of FU (Week 52)
Change in TUNEL Score From EOT to End of FU
Time frame: EOT (Week 28), end of FU (Week 52)
Change in Seminal Volume From Baseline to EOT and End of FU
Time frame: Baseline, EOT (Week 28), end of FU (Week 52)
Change in Seminal Volume From EOT to End FU
Time frame: EOT (Week 28), end of FU (Week 52)
Change in Sperm Density From EOT to End of FU
Time frame: EOT (Week 28), end of FU (Week 52)
Change in Sperm Density From Baseline to End of FU
Time frame: Baseline, end of FU (Week 52)
Change in Total Motility of Sperm From Baseline to EOT and End of FU
Time frame: Baseline, EOT (Week 28), end of FU (Week 52)
Change in Total Motility of Sperm From EOT to End of FU
Time frame: EOT (Week 28), end of FU (Week 52)
Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From Baseline to EOT and End of FU
Time frame: Baseline, EOT (Week 28), end of FU (Week 52)
Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From EOT to End of FU
Time frame: EOT (Week 28), end of FU (Week 52)
Change in Total Testosterone Level From Baseline to EOT and End of FU
Time frame: Baseline, EOT (Week 28), end of FU (Week 52)
Change in Total Testosterone Level From EOT to End of FU
Time frame: EOT (Week 28), end of FU (Week 52)
Change in LH Level From Baseline to EOT and End of FU
Time frame: Baseline, EOT (Week 28), end of FU (Week 52)
Change in LH Level From EOT to End of FU
Time frame: EOT (Week 28), end of FU (Week 52)
Change in FSH Level From Baseline to EOT and End of FU
Time frame: Baseline, EOT (Week 28), end of FU (Week 52)
Change in FSH Level From EOT to End of FU
Time frame: EOT (Week 28), end of FU (Week 52)
Change in Prolactin Level From Baseline to EOT and End of FU
Time frame: Baseline, EOT (Week 28), end of FU (Week 52)
Change in Prolactin Level From EOT to End of FU
Time frame: EOT (Week 28), end of FU (Week 52)
Change in Inhibin B Level From Baseline to EOT and End of FU
Time frame: Baseline, EOT (Week 28), end of FU (Week 52)
Change in Inhibin B Level From EOT to End of FU
Time frame: EOT (Week 28), end of FU (Week 52)
Percentage of Participants With Abnormal Sperm Density (<20 Mil/mL) From Baseline to EOT and End of FU
Time frame: Baseline, EOT (Week 28), end of FU (Week 52)
Percentage of Participants With Abnormal Sperm Density (<20 Mil/mL) From EOT to End of FU
Time frame: EOT (Week 28), end of FU (Week 52)
Percentage of Participants With Improved TUNEL Score From Baseline to EOT and End of FU
Time frame: Baseline, EOT (Week 28), end of FU (Week 52)
Percentage of Participants With Improved TUNEL Score From EOT to End of FU
Time frame: EOT (Week 28), end of FU (Week 52)
Percentage of Participants With Improved Sperm Density From Baseline to EOT and End of FU
Time frame: Baseline, EOT (Week 28), end of FU (Week 52)
Percentage of Participants With Improved Sperm Density From EOT to End of FU
Time frame: EOT (Week 28), end of FU (Week 52)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical Trials study director
Hoffmann-La Roche
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Valganciclovir in people with Cytomegalovirus Infections, run by Hoffmann-La Roche at 19 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 5 inclusion and 5 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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Mexico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 31 Aug 2018). 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?
Change in Sperm Density From Baseline to the End of Treatment (EOT) (time frame: Baseline, EOT (Week 28)). 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 31 Aug 2018.