Human PapillomavirusPhase 2NCT02576561
Safety and Efficacy Study of TVGV-1 Vaccine to Treat HPV Induced Cervical HSIL
A Phase 2 study testing TVGV-1 and GPI-0100 in people with Human Papillomavirus and High-Grade Squamous Intraepithelial Lesions, run by THEVAX Genetics Vaccine at 11 sites in United States.
Trial summary
The purpose of this research study is to test the safety and effectiveness of the investigational study vaccine, called TVGV-1. The study will test the vaccine in women with high grade HPV cervical infection. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Human Papillomavirus, High-Grade Squamous Intraepithelial Lesions
- What is being tested?
- TVGV-1 and GPI-0100
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 11 sitesUnited States
- Study dates
- Nov 2015to Sep 2018
- Phase
- Phase 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female age 18 to 55 years
- Written informed consent in accordance with institutional guidelines
- Negative pregnancy test (urine and blood tests)
- Women of child bearing potential must agree to use contraception through one menstrual cycle post end of study or if early withdrawal, through what would have been visit 11. Methods include intrauterine device or double barrier method, hormonal contraceptive in combination with a double barrier method.
- Patients who have ONLY HPV 16 OR HPV 16 AND 18 and no other High-Risk HPV by Cobas test will be included.
- Histologically confirmed, positive HSIL of CIN2+ or higher (only CIN2+/3 subjects will be selected) cervical biopsy, confirmed by external (independent) pathologist panel within the 12 weeks prior to enrollment. If the standard care biopsy is not available for evaluation by the independent pathologist, a fresh biopsy and endocervical curettage will be required. The extent of colposcopic HSIL disease should not involve more than two quadrants of the cervix. Biopsies should be taken from each affected quadrant
Show all 9Show fewer
- Adequate visualization of entire cervix, cervical lesion(s) and squamous-columnar junction
- Normal electrocardiogram (ECG), laboratory values (chemistry, complete blood count) and urinalysis, as judged Grade 0-1 by per National Cancer Institute Common Toxicity Criteria (NCI-CTC)
- Agrees to Loop Electrosurgical Excision Procedure (LEEP), Cold Knife Conization (CKC) or Hysterectomy being performed at the end of study according to the standard-of-care
Who cannot join
- History of cancer (excluding basal cell carcinoma of the skin) including cervical cancer
- Eastern Cooperative Oncology Group (ECOG) performance status >2 (See Appendix G)
- Administration of any blood product within 3 months of enrollment
- Active infection requiring antimicrobial treatment that would interfere with interpretation of adverse events, cutaneous reactions or efficacy. Treatment of minor concurrent infections should be limited to less than 10 days.
- Administration of any vaccine within 8 weeks of enrollment and within 4 weeks for flu vaccine.
- Participation in any study with an investigational compound or device within 30 days prior to signing informed consent
Show all 19Show fewer
- Any hematologic disorder involving platelets or clotting abnormalities or any condition requiring treatment with transfusions, anticoagulants except platelet inhibitors (NSAIDs as needed for pain are permitted)
- Active drug or alcohol use or dependence that, in the opinion of the Site Investigator, would interfere with adherence to study protocol
- Skin conditions that require consistent use of topical corticosteroids or other local or systemic therapy that may interfere with interpretation or description of skin-related adverse events linked to vaccination
- The standard criteria for prospective clinical trials of medications developed by Drug-Induced Liver Injury Network (established by The National Institute of Diabetes and Digestive and Kidney Diseases) will be used to assess the laboratory test abnormalities. Normal range for these labs will typically be 5 - 40 IU/L for AST; 7 - 56 IU/L for ALT; 0.2 - 1.2 mg/dL for bilirubin. Subjects will be excluded if values are x 2-x 2.5 the upper limit
- Evidence of hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, dermatologic, immune disorder, or other disease that may interfere with assessment of safety or efficacy of vaccine activity as indicated in study objectives
- Any known allergic reaction to vaccine components
- Any other medical condition(s) that, in the judgment of the Site Investigator, might interfere with the study or require treatment that might interfere with the study
- Family member of the investigation study staff
- Pregnant or breast-feeding
- Inability to provide informed consent
- A subject with a history or expectation of noncompliance with medications or treatment protocol
- Receipt of (e.g. Gardasil® or Cervarix®) HPV preventative vaccines within 8 years of study enrollment
- Excessive use of acetaminophen or other potentially hepatotoxic drugs
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Complete Healthcare for Women
Columbus, Ohio, 43231
Red Rocks OBGYN
Lakewood, Colorado, 80228
Insearch-Tidewater Clinical Research
Norfolk, Virginia, 23502
Penn Fertility Care/Reproductive Research Unit Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104
ProHEALTH Care Associates LLP
Port Jefferson, New York, 11777
Progressive Medical Research
Port Orange, Florida, 32127
Unified Women's Clinical Research
Raleigh, North Carolina, 27607
Visions Clinical Research - Tucson
Tucson, Arizona, 85712
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409
Unified Women's Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: Phase 2a Double-Blind, Randomized, Parallel Group, Dose-Ranging Study to Assess the Safety and Efficacy of Three Doses of TVGV-1 Vaccine Compared to Its Adjuvant, GPI-0100, in Subjects With Histologically Confirmed HPV Induced Cervical HSIL
The purpose of this research study is to test the safety and effectiveness of the investigational study vaccine, called TVGV-1. The study will test the vaccine in women with high grade HPV cervical infection.
Read the detailed description
The purpose of the Phase 2a Study VAX 02-01 is to assess the safety and activity of TVGV-1 vaccine construct in achieving the absence of histologic HSIL (CIN2/3) (regression to LSIL or less) as assessed by biopsy at last study Visit 11, Day 270.
The objective of the TVGV-1 program is to develop a non-surgical alternative that is reliable, safe, and would avoid potential surgical risks such as preterm birth, perinatal mortality, risk of infertility, incontinence and disfigurement, as well as reduced cost and inconvenience for an otherwise economically productive young subject population.
- Being tested
- TVGV-1, GPI-0100, Placebo
- Keywords
- human papillomavirus, Cervical Intraepithelial Neoplasia, Cold Knife Conization, hysterectomy, Loop Electrosurgical Excision Procedure, LEEP, HSIL, High-Grade Squamous Intraepithelial Lesion
- Medical subject headings
- Squamous Intraepithelial Lesions, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TVGV-1Biological
Also called lyophilized PEK fusion protein, GPI-0100, Antigen, Adjuvant
Antigen + Adjuvant
GPI-0100Biological
Also called Adjuvant
Adjuvant Alone
PlaceboBiological
Also called lyophilized placebo cak, placebo diluent, sterile water
Placebo
| Study group | Role | What they receive |
|---|---|---|
| TVGV-1 (cohort 1) | Experimental | Antigen + Adjuvant - 0.6 mg lyophilized PEK fusion protein + 0.6 ml* GPI- 0100 (1:1 ratio) Receives: Biological: TVGV-1 |
| GPI-0100 (cohort 1) | Active comparator | Adjuvant Alone - 0 mg lyophilized PEK fusion protein. 0.6 mg lyophilized placebo cake + 0.6 ml* GPI- 0100 (1:1 ratio) Receives: Biological: GPI-0100 |
| Placebo (cohort 1) | Placebo comparator | Placebo- 0 mg lyophilized PEK fusion protein. 0.6 mg lyophilized placebo cake + 0.6 ml placebo-diluent (1:1 ratio) Receives: Biological: Placebo |
| TVGV-1 (cohort 2) | Experimental | Antigen + Adjuvant - 0.9 mg lyophilized PEK fusion protein + 0.9 ml* GPI- 0100 (1:1 ratio) Receives: Biological: TVGV-1 |
| GPI-0100 (cohort 2) | Active comparator | Adjuvant Alone - 0 mg lyophilized PEK fusion protein. 0.9 mg lyophilized placebo cake + 0.9 ml* GPI- 0100 (1:1 ratio) Receives: Biological: GPI-0100 |
| Placebo (cohort 2) | Placebo comparator | Placebo - 0 mg lyophilized PEK fusion protein. 0.9 mg lyophilized placebo cake + 0.9 ml placebo diluent (1:1 ratio) Receives: Biological: Placebo |
| TVGV-1 (cohort 3) | Experimental | Antigen + Adjuvant - 1.2 mg lyophilized PEK fusion protein + 1.2 ml* GPI- 0100 (1:1 ratio) Receives: Biological: TVGV-1 |
| GPI-0100 (cohort 3) | Active comparator | Adjuvant Alone - 0 mg lyophilized PEK fusion protein + 1.2 mg lyophilized placebo cake 1.2 ml* GPI- 0100 (1:1 ratio) Receives: Biological: GPI-0100 |
| Placebo (cohort 3) | Placebo comparator | Placebo - 0 mg lyophilized PEK fusion protein. 1.2 mg lyophilized placebo cake + 1.2 ml placebo-diluent (1:1 ratio) Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of histologic HSIL (CIN2/3) as assessed by biopsy at last study Visit 11, Day 270.
The primary analysis for efficacy will be a comparison between subjects treated with and without the PEK fusion protein with respect to the percentage who present regression of HSIL at Day 270. Separate comparisons within each cohort will be performed using Fisher's exact test (or an appropriate analogue). No adjustment for multiple comparisons will be employed in these analyses. Additionally, a corresponding comparison across all study subjects combined will be performed, based on Cochran-Matel-Haenszel test stratified for cohort.
Measured: DAY 270
Assessment of cutaneous toxicities (i.e., size, induration and time to resolution of skin reactions to vaccine).
Summaries of the data pertaining to the primary safety outcome of skin toxicity will be provided. Summaries will be provided for the within-cohort subsets of subjects treated with the active, and with the adjuvant alone; and the combined subsets across all three cohorts of subject treated with the active, with the adjuvant alone, and with the placebo. Serious adverse events will be described in narrative with the participant's demographics, treatment date, event, onset date, relationship to the study treatment and the descriptions of the actions and outcomes during this event. Any deaths occurring in the study will be summarized in narrative with the demographics, treatment duration, cause of death, date of death and additional information surrounding that serious adverse event.
Measured: DAY 270
Secondary outcomes (2)
Absence of HPV16 in cervical cytological specimen. Absence of cervical dysplasia 6 months and 8 months after last dose of TVGV-1.
The primary analysis for efficacy will be a comparison between subjects treated with and without the PEK fusion protein with respect to the percentage who present regression of HSIL at Day 270. Separate comparisons within each cohort will be performed using Fisher's exact test (or an appropriate analogue). No adjustment for multiple comparisons will be employed in these analyses. Additionally, a corresponding comparison across all study subjects combined will be performed, based on Cochran-Matel-Haenszel test stratified for cohort.
Measured: DAY 270
Assessment of clinical or laboratory findings and other safety variables.
Appropriate laboratory data will be transformed prior to analysis as defined in the Statistical Analysis Plan (SAP). Summaries will be presented for each evaluation time point, as well as for changes from baseline. Changes from baseline will also be presented using shift tables for selected laboratory parameters.
Measured: DAy 270
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human PapillomavirusStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- THEVAX Genetics Vaccine
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Research Management, Inc.
- Responsible party
- Sponsor
- Investigators
- Frank L Douglas, PhD, MD, Study director, THEVAX Genetics Vaccine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576561
- Sponsor's protocol ID
- VAX 02-01
- Status last verified
- Oct 2017
- First submitted
- 9 Oct 2015
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a Double-Blind, Randomized, Parallel Group, Dose-Ranging Study to Assess the Safety and Efficacy of Three Doses of TVGV-1 Vaccine Compared to Its Adjuvant, GPI-0100, in Subjects With Histologically Confirmed HPV Induced Cervical HSIL
- ClinicalTrials.gov ID
- NCT02576561
- Acronym / sponsor ID
- VAX 02-01
- Keywords
- human papillomavirus, Cervical Intraepithelial Neoplasia, Cold Knife Conization, hysterectomy, Loop Electrosurgical Excision Procedure, LEEP, HSIL, High-Grade Squamous Intraepithelial Lesion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- THEVAX Genetics VaccineIndustry (pharma, biotech, devices)
- Collaborators
- Clinical Research Management, Inc.
- Study start
- Nov 2015
- Primary completion
- May 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 15 Oct 2015 (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 purpose of this research study is to test the safety and effectiveness of the investigational study vaccine, called TVGV-1. The study will test the vaccine in women with high grade HPV cervical infection.
Detailed description
The purpose of the Phase 2a Study VAX 02-01 is to assess the safety and activity of TVGV-1 vaccine construct in achieving the absence of histologic HSIL (CIN2/3) (regression to LSIL or less) as assessed by biopsy at last study Visit 11, Day 270.
The objective of the TVGV-1 program is to develop a non-surgical alternative that is reliable, safe, and would avoid potential surgical risks such as preterm birth, perinatal mortality, risk of infertility, incontinence and disfigurement, as well as reduced cost and inconvenience for an otherwise economically productive young subject population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| TVGV-1 (cohort 1) | Experimental | Biological: TVGV-1Antigen + Adjuvant - 0.6 mg lyophilized PEK fusion protein + 0.6 ml* GPI- 0100 (1:1 ratio) |
| GPI-0100 (cohort 1) | Active comparator | Biological: GPI-0100Adjuvant Alone - 0 mg lyophilized PEK fusion protein. 0.6 mg lyophilized placebo cake + 0.6 ml* GPI- 0100 (1:1 ratio) |
| Placebo (cohort 1) | Placebo comparator | Biological: PlaceboPlacebo- 0 mg lyophilized PEK fusion protein. 0.6 mg lyophilized placebo cake + 0.6 ml placebo-diluent (1:1 ratio) |
| TVGV-1 (cohort 2) | Experimental | Biological: TVGV-1Antigen + Adjuvant - 0.9 mg lyophilized PEK fusion protein + 0.9 ml* GPI- 0100 (1:1 ratio) |
| GPI-0100 (cohort 2) | Active comparator | Biological: GPI-0100Adjuvant Alone - 0 mg lyophilized PEK fusion protein. 0.9 mg lyophilized placebo cake + 0.9 ml* GPI- 0100 (1:1 ratio) |
| Placebo (cohort 2) | Placebo comparator | Biological: PlaceboPlacebo - 0 mg lyophilized PEK fusion protein. 0.9 mg lyophilized placebo cake + 0.9 ml placebo diluent (1:1 ratio) |
| TVGV-1 (cohort 3) | Experimental | Biological: TVGV-1Antigen + Adjuvant - 1.2 mg lyophilized PEK fusion protein + 1.2 ml* GPI- 0100 (1:1 ratio) |
| GPI-0100 (cohort 3) | Active comparator | Biological: GPI-0100Adjuvant Alone - 0 mg lyophilized PEK fusion protein + 1.2 mg lyophilized placebo cake 1.2 ml* GPI- 0100 (1:1 ratio) |
| Placebo (cohort 3) | Placebo comparator | Biological: PlaceboPlacebo - 0 mg lyophilized PEK fusion protein. 1.2 mg lyophilized placebo cake + 1.2 ml placebo-diluent (1:1 ratio) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Female age 18 to 55 years
- Written informed consent in accordance with institutional guidelines
- Negative pregnancy test (urine and blood tests)
- Women of child bearing potential must agree to use contraception through one menstrual cycle post end of study or if early withdrawal, through what would have been visit 11. Methods include intrauterine device or double barrier method, hormonal contraceptive in combination with a double barrier method.
- Patients who have ONLY HPV 16 OR HPV 16 AND 18 and no other High-Risk HPV by Cobas test will be included.
Key exclusion criteria (19 listed)
- History of cancer (excluding basal cell carcinoma of the skin) including cervical cancer
- Eastern Cooperative Oncology Group (ECOG) performance status >2 (See Appendix G)
- Administration of any blood product within 3 months of enrollment
- Active infection requiring antimicrobial treatment that would interfere with interpretation of adverse events, cutaneous reactions or efficacy. Treatment of minor concurrent infections should be limited to less than 10 days.
- Administration of any vaccine within 8 weeks of enrollment and within 4 weeks for flu vaccine.
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 |
|---|---|---|
| TVGV-1Also: lyophilized PEK fusion protein, GPI-0100, Antigen, AdjuvantAntigen + Adjuvant | Biological | TVGV-1 (cohort 1), TVGV-1 (cohort 2), TVGV-1 (cohort 3) |
| GPI-0100Also: AdjuvantAdjuvant Alone | Biological | GPI-0100 (cohort 1), GPI-0100 (cohort 2), GPI-0100 (cohort 3) |
| PlaceboAlso: lyophilized placebo cak, placebo diluent, sterile waterPlacebo | Biological | Placebo (cohort 1), Placebo (cohort 2), Placebo (cohort 3) |
Primary outcome
Absence of histologic HSIL (CIN2/3) as assessed by biopsy at last study Visit 11, Day 270.
Time frame: DAY 270
The primary analysis for efficacy will be a comparison between subjects treated with and without the PEK fusion protein with respect to the percentage who present regression of HSIL at Day 270. Separate comparisons within each cohort will be performed using Fisher's exact test (or an appropriate analogue). No adjustment for multiple comparisons will be employed in these analyses. Additionally, a corresponding comparison across all study subjects combined will be performed, based on Cochran-Matel-Haenszel test stratified for cohort.
Assessment of cutaneous toxicities (i.e., size, induration and time to resolution of skin reactions to vaccine).
Time frame: DAY 270
Summaries of the data pertaining to the primary safety outcome of skin toxicity will be provided. Summaries will be provided for the within-cohort subsets of subjects treated with the active, and with the adjuvant alone; and the combined subsets across all three cohorts of subject treated with the active, with the adjuvant alone, and with the placebo. Serious adverse events will be described in narrative with the participant's demographics, treatment date, event, onset date, relationship to the study treatment and the descriptions of the actions and outcomes during this event. Any deaths occurring in the study will be summarized in narrative with the demographics, treatment duration, cause of death, date of death and additional information surrounding that serious adverse event.
2 secondary outcomes
Absence of HPV16 in cervical cytological specimen. Absence of cervical dysplasia 6 months and 8 months after last dose of TVGV-1.
Time frame: DAY 270
Assessment of clinical or laboratory findings and other safety variables.
Time frame: DAy 270
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
Related trials for Human Papillomavirus
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
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.
Frank L Douglas, PhD, MD study director
THEVAX Genetics Vaccine
11 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 TVGV-1 and GPI-0100 in people with Human Papillomavirus and High-Grade Squamous Intraepithelial Lesions, run by THEVAX Genetics Vaccine at 11 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 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 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?
Results are not available in the source record.
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?
Absence of histologic HSIL (CIN2/3) as assessed by biopsy at last study Visit 11, Day 270. (time frame: DAY 270). The study lists 2 primary outcomes in all. 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 25 Oct 2017.