Hepatitis CNCT02904252
The Prevalence and Severity of HCV Infection in Thalassemia Major and Thalassemia Intermedia in Siriraj Hospital
An observational study of Hepatitis C and Fibrosis, run by Mahidol University at 1 site in Thailand.
Trial summary
The primary objective is to assess the prevalence and genotypes of HCV infection in thalassemia major and thalassemia intermediate patients who have received blood transfusion in the Department of Medicine, Faculty of Medicine Siriraj Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Fibrosis, Thalassemia
- What is being tested?
- Transient elastography
- How many people
- 158 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2016to 31 Oct 2016
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participants are thalassemia patients who regularly visit Hematology Clinic, Department of Medicine, Faculty of Medicine Siriraj Hospital
Who may be able to join
- Previously diagnosed thalassemia major, for example homozygous beta thalassemia or beta thalassemia/hemoglobin E disease or thalassemia intermedia such as hemoglobin H disease or homozygous Hb CS
- Age equal to or more than 18 years
- Previous history of blood transfusion
Who cannot join
- Patients who have hepatocellular carcinoma, ascites or pregnancy will be excluded from the study due to the limitation of result interpretation.
- Unwilling to participate
- Patient who receiving or completed treatment of hepatitis C
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective is to assess the prevalence and genotypes of HCV infection in thalassemia major and thalassemia intermediate patients who have received blood transfusion in the Department of Medicine, Faculty of Medicine Siriraj Hospital.
The secondary objective is to identify the effect of HCV infection as well as the risk factors of advanced liver disease and liver cirrhosis in these patients
The third objective is to identify the role of serum HA level and fibrotest in the prediction of cirrhosis in these patients.
Read the detailed description
Study protocol
Data collection:
The eligible patients will be asked to participate in the study. After signing informed consent, the patients will be asked to complete questionnaire, all clinical and laboratory data of the patients will be retrieved from out-patient electronic or paper medical records, electronic laboratory results. The data will include the followings:
- Clinical data
- Demographic information (age, gender, ethnicity, education, marital status)
- Family history of liver disease
- Current relevant medication
- Weight, height and body mass index (BMI) at the time of enrollment
- History of blood or blood product transfusion, last transfusion
- History of alcohol consumption
- History of active liver disease
- Laboratory data
- Complete blood count
- Iron study (serum ferritin, serum iron, total iron binding capacity and transferrin saturation)
- Hemoglobin typing
- HIV antibody status (only if available)
- liver biochemistry including AST, ALT, albumin, globulin
- Blood urea nitrogen, creatinine
- HBsAg, Anti-HBsAb
- Anti-HCV antibody
- HCV RNA, HCV genotyping (only in patients with positive Anti-HCV)
- Serum hyaluronic acid
- Fibrotest
After data collection, all patients will receive blood test for serum hyaluronic acid. If the patients have incomplete laboratory data (except HIV antibody status), they will receive additional blood tests for missing data. All patients will be appointed for transient elastography. All the cost for the extra-investigation will be supported by the study.
Transient elastography (TE or Fibroscan):
TE will be used to evaluate liver fibrosis. TE will be performed in all patients by examiners who were blind to clinical, laboratory data. The right lobe of the liver was targeted through an intercostal space access while the patient was lying in the dorsal decubitus position with the right arm in maximal abduction. With the assistance of TE, a liver portion of at least 6-cm thickness, free of large vessels, was identified for examination. The rate of successful measurements was interpreted by the ratio between the number of those validated and total number of measurements. The results were expressed as a median value of the total measurements in kPa. Patients with ascites were excluded from the study due to the limitation of result interpretation.
Data Handling :
Data of each patient will be collected at the OPD, Division of Hematology and Division of Gastroenterology, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
The study will be started after it is approved by the Ethics Committee ofSiriraj Hospital. Patients' identification number will be stored in a separate log book. Results will be reported at the aggregate level only, and individual-level data will never be released.
Sample Size and Statistical analysis Sample size The primary research question of this study is to assess the prevalence of HCV infection in thalassemia major and thalassemia intermediate patients who received prior blood transfusion. From the previous research conducted by Wanachiwanawin W, et al , we estimate that the prevalence of hepatitis C viral infection in thalassemia patient is 20 percent. The sample size is 246 samples according to the calculation with 95 % confident interval.
Statistical analysis
- The quantitative data, such as age, will be analyzed by mean and standard deviation or by mode and median (in the data that doesn't have normal distribution). The quantitative data, such as sex, will be analyzed by using percentage and 95% confident interval for the prevalence.
- In comparison between two groups, the quantitative data, such as liver fibrosis: positive or negative, will be compared by using t-test (normality) or Mann-Whitney U-test (non-normality) and the quantitative data will be analyzed by Chi-square test or Fisher's exact test. If the results show statistically significance (P-value <0.05) more than one value, the Logistic Regression Analysis will be performed and presented by odds ratio and 95% confidence interval.
- Conditions
- Hepatitis C, Fibrosis, Thalassemia
- Being tested
- Transient elastography
- Keywords
- Transient elastography, Fibrotest
- Medical subject headings
- Hepatitis C, Fibrosis, Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transient elastographyOther
Also called Fibroscan
Transient elastography (TE) is an ultrasound-based device used for measuring the degree of liver stiffness. A transducer probe is used to create mild amplitude and low frequency vibrations (50 Hz) that transmitted through the liver tissue. This results in an elastic shear wave that propagates through the underlying liver tissue. The probe then utilizes pulse-echo ultrasound to follow the propagation of the shear wave and to measure its velocity. The velocity of the wave is directly related to tissue stiffness which correlates with fibrosis. The sensitivity and the specificity of TE is between 68%-88% and between 66%-100%, respectively for the detection of significant liver fibrosis (METAVIR score F>2).
| Study group | Role | What they receive |
|---|---|---|
| Study group | Population : The participants are thalassemia patients who regularly visit Hematology Clinic, Department of Medicine, Faculty of Medicine Siriraj Hospital Clinical data, Laboratory data (Blood samples) and Transient elastography data will be collected from all participants, as previously described. Receives: Other: Transient elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and genotypes of HCV infection in thalassemia major and thalassemia intermediate patients who have received blood transfusion in the Department of Medicine, Faculty of Medicine Siriraj Hospital
Measured: 1 year
Secondary outcomes (2)
Effect of HCV infection and the risk factors of advanced liver disease and liver cirrhosis in thalassemia major and thalassemia intermediate patients who have received blood transfusion
Measured: 1 year
Role of serum HA level and fibrotest in the prediction of cirrhosis in thalassemia major and thalassemia intermediate patients who have received blood transfusion in the Department of Medicine, Faculty of Medicine Siriraj Hospital.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study start1 Jan 2016
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tawesak Tanwandee, Assoc.Prof., Principal investigator, Division of Gastroenterology, Faculty of Medicine, Siriraj hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904252
- Sponsor's protocol ID
- 481/2558
- Status last verified
- Mar 2017
- First submitted
- 13 Sep 2016
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Due to patients confidentiality in study protocol. The individual level data will not be released.
Publications
Borgna-Pignatti C, Garani MC, Forni GL, Cappellini MD, Cassinerio E, Fidone C, Spadola V, Maggio A, Restivo Pantalone G, Piga A, Longo F, Gamberini MR, Ricchi P, Costantini S, D'Ascola D, Cianciulli P, Lai ME, Carta MP, Ciancio A, Cavalli P, Putti MC, Barella S, Amendola G, Campisi S, Capra M, Caruso V, Colletta G, Volpato S. Hepatocellular carcinoma in thalassaemia: an update of the Italian Registry. Br J Haematol. 2014 Oct;167(1):121-6. doi: 10.1111/bjh.13009. Epub 2014 Jul 3.
PubMed 24992281Kountouras D, Tsagarakis NJ, Fatourou E, Dalagiorgos E, Chrysanthos N, Berdoussi H, Vgontza N, Karagiorga M, Lagiandreou A, Kaligeros K, Voskaridou E, Roussou P, Diamanti-Kandarakis E, Koskinas J. Liver disease in adult transfusion-dependent beta-thalassaemic patients: investigating the role of iron overload and chronic HCV infection. Liver Int. 2013 Mar;33(3):420-7. doi: 10.1111/liv.12095.
PubMed 23402611Wilder J, Patel K. The clinical utility of FibroScan((R)) as a noninvasive diagnostic test for liver disease. Med Devices (Auckl). 2014 May 3;7:107-14. doi: 10.2147/MDER.S46943. eCollection 2014.
PubMed 24833926Fraquelli M, Cassinerio E, Roghi A, Rigamonti C, Casazza G, Colombo M, Massironi S, Conte D, Cappellini MD. Transient elastography in the assessment of liver fibrosis in adult thalassemia patients. Am J Hematol. 2010 Aug;85(8):564-8. doi: 10.1002/ajh.21752.
PubMed 20658587Fucharoen S, Winichagoon P. Haemoglobinopathies in southeast Asia. Indian J Med Res. 2011 Oct;134(4):498-506.
PubMed 22089614Wanachiwanawin W, Luengrojanakul P, Sirangkapracha P, Leowattana W, Fucharoen S. Prevalence and clinical significance of hepatitis C virus infection in Thai patients with thalassemia. Int J Hematol. 2003 Nov;78(4):374-8. doi: 10.1007/BF02983565.
PubMed 14686498Papastamataki M, Delaporta P, Premetis E, Kattamis A, Ladis V, Papassotiriou I. Evaluation of liver fibrosis in patients with thalassemia: the important role of hyaluronic acid. Blood Cells Mol Dis. 2010 Oct 15;45(3):215-8. doi: 10.1016/j.bcmd.2010.06.002. Epub 2010 Jul 6.
PubMed 20605573El-Shabrawi MH, Zein El Abedin MY, Omar N, Kamal NM, Elmakarem SA, Khattab S, El-Sayed HM, El-Hennawy A, Ali AS. Predictive accuracy of serum hyaluronic acid as a non-invasive marker of fibrosis in a cohort of multi-transfused Egyptian children with beta-thalassaemia major. Arab J Gastroenterol. 2012 Jun;13(2):45-8. doi: 10.1016/j.ajg.2012.06.006. Epub 2012 Jul 11.
PubMed 22980590
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence and Severity of HCV Infection in Thalassemia Major and Thalassemia Intermedia in Siriraj Hospital
- ClinicalTrials.gov ID
- NCT02904252
- Acronym / sponsor ID
- 481/2558
- Conditions
- Hepatitis C, Fibrosis, Thalassemia
- Keywords
- Transient elastography, Fibrotest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 16 Sep 2016 (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 primary objective is to assess the prevalence and genotypes of HCV infection in thalassemia major and thalassemia intermediate patients who have received blood transfusion in the Department of Medicine, Faculty of Medicine Siriraj Hospital.
The secondary objective is to identify the effect of HCV infection as well as the risk factors of advanced liver disease and liver cirrhosis in these patients
The third objective is to identify the role of serum HA level and fibrotest in the prediction of cirrhosis in these patients.
Detailed description
Study protocol
Data collection:
The eligible patients will be asked to participate in the study. After signing informed consent, the patients will be asked to complete questionnaire, all clinical and laboratory data of the patients will be retrieved from out-patient electronic or paper medical records, electronic laboratory results. The data will include the followings:
- Clinical data
- Demographic information (age, gender, ethnicity, education, marital status)
- Family history of liver disease
- Current relevant medication
- Weight, height and body mass index (BMI) at the time of enrollment
- History of blood or blood product transfusion, last transfusion
- History of alcohol consumption
- History of active liver disease
- Laboratory data
- Complete blood count
- Iron study (serum ferritin, serum iron, total iron binding capacity and transferrin saturation)
- Hemoglobin typing
- HIV antibody status (only if available)
- liver biochemistry including AST, ALT, albumin, globulin
- Blood urea nitrogen, creatinine
- HBsAg, Anti-HBsAb
- Anti-HCV antibody
- HCV RNA, HCV genotyping (only in patients with positive Anti-HCV)
- Serum hyaluronic acid
- Fibrotest
After data collection, all patients will receive blood test for serum hyaluronic acid. If the patients have incomplete laboratory data (except HIV antibody status), they will receive additional blood tests for missing data. All patients will be appointed for transient elastography. All the cost for the extra-investigation will be supported by the study.
Transient elastography (TE or Fibroscan):
TE will be used to evaluate liver fibrosis. TE will be performed in all patients by examiners who were blind to clinical, laboratory data. The right lobe of the liver was targeted through an intercostal space access while the patient was lying in the dorsal decubitus position with the right arm in maximal abduction. With the assistance of TE, a liver portion of at least 6-cm thickness, free of large vessels, was identified for examination. The rate of successful measurements was interpreted by the ratio between the number of those validated and total number of measurements. The results were expressed as a median value of the total measurements in kPa. Patients with ascites were excluded from the study due to the limitation of result interpretation.
Data Handling :
Data of each patient will be collected at the OPD, Division of Hematology and Division of Gastroenterology, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
The study will be started after it is approved by the Ethics Committee ofSiriraj Hospital. Patients' identification number will be stored in a separate log book. Results will be reported at the aggregate level only, and individual-level data will never be released.
Sample Size and Statistical analysis Sample size The primary research question of this study is to assess the prevalence of HCV infection in thalassemia major and thalassemia intermediate patients who received prior blood transfusion. From the previous research conducted by Wanachiwanawin W, et al , we estimate that the prevalence of hepatitis C viral infection in thalassemia patient is 20 percent. The sample size is 246 samples according to the calculation with 95 % confident interval.
Statistical analysis
- The quantitative data, such as age, will be analyzed by mean and standard deviation or by mode and median (in the data that doesn't have normal distribution). The quantitative data, such as sex, will be analyzed by using percentage and 95% confident interval for the prevalence.
- In comparison between two groups, the quantitative data, such as liver fibrosis: positive or negative, will be compared by using t-test (normality) or Mann-Whitney U-test (non-normality) and the quantitative data will be analyzed by Chi-square test or Fisher's exact test. If the results show statistically significance (P-value <0.05) more than one value, the Logistic Regression Analysis will be performed and presented by odds ratio and 95% confidence interval.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Transient elastographyPopulation : The participants are thalassemia patients who regularly visit Hematology Clinic, Department of Medicine, Faculty of Medicine Siriraj Hospital Clinical data, Laboratory data (Blood samples) and Transient elastography data will be collected from all participants, as previously described. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants are thalassemia patients who regularly visit Hematology Clinic, Department of Medicine, Faculty of Medicine Siriraj Hospital
Key inclusion criteria (3 listed)
- Previously diagnosed thalassemia major, for example homozygous beta thalassemia or beta thalassemia/hemoglobin E disease or thalassemia intermedia such as hemoglobin H disease or homozygous Hb CS
- Age equal to or more than 18 years
- Previous history of blood transfusion
Key exclusion criteria (3 listed)
- Patients who have hepatocellular carcinoma, ascites or pregnancy will be excluded from the study due to the limitation of result interpretation.
- Unwilling to participate
- Patient who receiving or completed treatment of hepatitis C
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 |
|---|---|---|
| Transient elastographyAlso: FibroscanTransient elastography (TE) is an ultrasound-based device used for measuring the degree of liver stiffness. A transducer probe is used to create mild amplitude and low frequency vibrations (50 Hz) that transmitted through the liver tissue. This results in an elastic shear wave that propagates through the underlying liver tissue. The probe then utilizes pulse-echo ultrasound to follow the propagation of the shear wave and to measure its velocity. The velocity of the wave is directly related to tissue stiffness which correlates with fibrosis. The sensitivity and the specificity of TE is between 68%-88% and between 66%-100%, respectively for the detection of significant liver fibrosis (METAVIR score F>2). | Other | Study group |
Primary outcome
Prevalence and genotypes of HCV infection in thalassemia major and thalassemia intermediate patients who have received blood transfusion in the Department of Medicine, Faculty of Medicine Siriraj Hospital
Time frame: 1 year
2 secondary outcomes
Effect of HCV infection and the risk factors of advanced liver disease and liver cirrhosis in thalassemia major and thalassemia intermediate patients who have received blood transfusion
Time frame: 1 year
Role of serum HA level and fibrotest in the prediction of cirrhosis in thalassemia major and thalassemia intermediate patients who have received blood transfusion in the Department of Medicine, Faculty of Medicine Siriraj Hospital.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Background: PubMed 24992281Borgna-Pignatti C, Garani MC, Forni GL, Cappellini MD, Cassinerio E, Fidone C, Spadola V, Maggio A, Restivo Pantalone G, Piga A, Longo F, Gamberini MR, Ricchi P, Costantini S, D'Ascola D, Cianciulli P, Lai ME, Carta MP, Ciancio A, Cavalli P, Putti MC, Barella S, Amendola G, Campisi S, Capra M, Caruso V, Colletta G, Volpato S. Hepatocellular carcinoma in thalassaemia: an update of the Italian Registry. Br J Haematol. 2014 Oct;167(1):121-6. doi: 10.1111/bjh.13009. Epub 2014 Jul 3.
- Background: PubMed 23402611Kountouras D, Tsagarakis NJ, Fatourou E, Dalagiorgos E, Chrysanthos N, Berdoussi H, Vgontza N, Karagiorga M, Lagiandreou A, Kaligeros K, Voskaridou E, Roussou P, Diamanti-Kandarakis E, Koskinas J. Liver disease in adult transfusion-dependent beta-thalassaemic patients: investigating the role of iron overload and chronic HCV infection. Liver Int. 2013 Mar;33(3):420-7. doi: 10.1111/liv.12095.
- Background: PubMed 24833926Wilder J, Patel K. The clinical utility of FibroScan((R)) as a noninvasive diagnostic test for liver disease. Med Devices (Auckl). 2014 May 3;7:107-14. doi: 10.2147/MDER.S46943. eCollection 2014.
- Background: PubMed 20658587Fraquelli M, Cassinerio E, Roghi A, Rigamonti C, Casazza G, Colombo M, Massironi S, Conte D, Cappellini MD. Transient elastography in the assessment of liver fibrosis in adult thalassemia patients. Am J Hematol. 2010 Aug;85(8):564-8. doi: 10.1002/ajh.21752.
- Background: PubMed 22089614Fucharoen S, Winichagoon P. Haemoglobinopathies in southeast Asia. Indian J Med Res. 2011 Oct;134(4):498-506.
- Results publication: PubMed 14686498Wanachiwanawin W, Luengrojanakul P, Sirangkapracha P, Leowattana W, Fucharoen S. Prevalence and clinical significance of hepatitis C virus infection in Thai patients with thalassemia. Int J Hematol. 2003 Nov;78(4):374-8. doi: 10.1007/BF02983565.
- Results publication: PubMed 20605573Papastamataki M, Delaporta P, Premetis E, Kattamis A, Ladis V, Papassotiriou I. Evaluation of liver fibrosis in patients with thalassemia: the important role of hyaluronic acid. Blood Cells Mol Dis. 2010 Oct 15;45(3):215-8. doi: 10.1016/j.bcmd.2010.06.002. Epub 2010 Jul 6.
- Results publication: PubMed 22980590El-Shabrawi MH, Zein El Abedin MY, Omar N, Kamal NM, Elmakarem SA, Khattab S, El-Sayed HM, El-Hennawy A, Ali AS. Predictive accuracy of serum hyaluronic acid as a non-invasive marker of fibrosis in a cohort of multi-transfused Egyptian children with beta-thalassaemia major. Arab J Gastroenterol. 2012 Jun;13(2):45-8. doi: 10.1016/j.ajg.2012.06.006. Epub 2012 Jul 11.
- Individual participant dataSharing planned: No. Due to patients confidentiality in study protocol. The individual level data will not be released.
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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.
Tawesak Tanwandee, Assoc.Prof. principal investigator
Division of Gastroenterology, Faculty of Medicine, Siriraj hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C and Fibrosis, run by Mahidol University at 1 site in Thailand.
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 3 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 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and genotypes of HCV infection in thalassemia major and thalassemia intermediate patients who have received blood transfusion in the Department of Medicine, Faculty of Medicine Siriraj Hospital (time frame: 1 year). 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 NCT02904252, which also lists 8 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 23 Mar 2017.