Chronic Hepaititis BPhase 4NCT02068365
An Open-label Trial of 48-week Peginterferon Alfa-2a (PEGASYS) to Assess the Sustained Response of Chronic Hepatitis B Patients With HBeAg Seroconversion on Nucleot(s)Ide Analogue Therapy
A Phase 4 study testing Pegyinterferon-alfa-2a in people with Chronic Hepaititis B, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a multi-center, single-arm, open-label study on the virological response of chronic HBV infection to pegyinterferon-alfa-2a among patients who achieved HBeAg seroconversion on nucleos(t)ide analogue (NA) treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepaititis B
- What is being tested?
- Pegyinterferon-alfa-2a
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteHong Kong
- Study dates
- Jun 2013to Jun 2019
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male \& female patients >= 18 and < 70 years of age
- Positive HBeAg before starting NA treatment
- Treated by a single NA (lamivudine, adefovir, entecavir or tenofovir) for 6 months to 5 years
- Developed HBeAg seroconversion (HBeAg negative and ant-HBe negative) with undetectable HBV DNA by PCR based assay on NA treatment.
- Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug. Additionally, all females must be using reliable contraception during the study and for 3 months after treatment completion
Who cannot join
- Evidence of decompensated liver disease (Childs B-C), hepato-cellular carcinoma, pre-existing severe depression or other psychiatric disease, significant cardiac disease, significant renal disease, seizure disorders or severe retinopathy.
- received telbivudine as the antiviral therapy or have received more than one NA in the past.
- received interferon or peginterferon treatment in the past.
- received antiviral therapy for any systemic anti-viral, anti-neoplastic or immuno-modulatory treatment (including supraphysiologic doses of steroids and radiation) within the past 6 months.
- Positive test at screening for anti-HIV, anti-HCV.
- Patients who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded. Exception: patients who have had a limited (<=7 days) course of acyclovir for herpetic lesions more than 1 month prior to the first administration of test drug are not excluded.
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- Serum total bilirubin > 3 times the upper limit of normal at screening.
- History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease.
- History or other evidence of a medical condition associated with chronic liver disease other than HBV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver diseases including Wilson's and alpha1-antitrypsin deficiency, alcoholic liver disease, toxin exposures, thalassemia).
- Women with ongoing pregnancy or who are breast feeding.
- Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening.
- Hemoglobin < 11.5 g/dL for females and < 12.5 g/dL for men at screening.
- Serum creatinine level >120 umol/ml for men and >105 umol/ml for women at screening.
- History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as major depression or psychosis, a period of treatment with an antidepressant medication or major tranquilizer at therapeutic doses for depression or psychosis for at least 3 months, a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease.
- History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis).
- History or other evidence of chronic pulmonary disease associated with functional limitation. Severe cardiac disease (e.g., NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases).
- History of a severe seizure disorder or current anticonvulsant use.
- Evidence of an active or suspected cancer or a history of malignancy where the risk of recurrence is >=20% within 2 years. Patients with a lesion suspicious of hepatic malignancy on a screening imaging study will only be eligible if the likelihood of carcinoma is <=10% following an appropriate evaluation.
- History of having received any systemic anti-neoplastic (including radiation) or immunomodulatory treatment (including systemic corticosteroids) <=6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
- Major organ transplantation.
- Thyroid disease with thyroid function poorly controlled on prescribed medications. Patients with abnormal thyroid stimulating hormone or T4 concentrations, with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease are excluded.
- History or other evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension
- Inability or unwillingness to provide informed consent or abide by the requirements of the study.
- History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.
- Patients with a value of alpha-fetoprotein >100 ng/mL are excluded, unless stability (less than 10% increase) has been documented over at least the previous 3 months.
- Evidence of drug and/or alcohol abuse (20g/day for women \& 30g/day for men).
- Patients included in another trial or having been given investigational drugs within 12 weeks prior to screening
- Any known history of hypersensitivity to interferon.
Trial locations and contacts
1 site in 1 country.
About this study
This is a multi-center, single-arm, open-label study on the virological response of chronic HBV infection to pegyinterferon-alfa-2a among patients who achieved HBeAg seroconversion on nucleos(t)ide analogue (NA) treatment. The primary endpoint of this study is to investigate the sustained response (HBeAg seroconversion with HBV DNA <2000 IU/ml) to peginterferon at 24 weeks after the end of treatment.
Read the detailed description
Chronic hepatitis B is the commonest cause of liver cirrhosis and hepatocellular carcinoma in Hong Kong. Treatment with interferon and nucleos(t)ide analogues (NA) can reduce the risk of HCC. NA is the commonest used medication in Hong Kong. However, most patients require long-term treatment and premature drug cessation may lead to hepatitis relapse.
Under the current regional guidelines, patients who have positive hepatitis B e antigen (HBeAg) treated by NA can consider stopping treatment if HBeAg seroconversion has developed for at least 12 months. However, up to 30-50% of patients may develop virological relapse and/or HBeAg reversion after cessation of treatment. On the other hand, interferon-based treatment has a much more durable response. HBeAg seroconversion is maintained in 80% of patients after successful treatment with peginterferon. Upon long-term follow-up, peginterferon-treated patients are also more likely to achieve hepatitis B surface antigen (HBsAg) seroclearance, a condition closest to a cure of chronic hepatitis B.
- Conditions
- Chronic Hepaititis B
- Being tested
- Pegyinterferon-alfa-2a
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegyinterferon-alfa-2aDrug
Pegyinterferon-alfa-2a 180mcq weekly for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pegyinterferon-alfa-2a | Other | Pegyinterferon-alfa-2a 180mcq weekly for 48 weeks Receives: Drug: Pegyinterferon-alfa-2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained response (HBeAg seroconversion and HBV DNA <2000 IU/ml)
Measured: 24 weeks post-treatment
Secondary outcomes (5)
HBeAg loss and seroconversion
Measured: 24 weeks post-treatment and follow up for 5 years.
HBsAg loss and seroconversion
Measured: 24 weeks post-treatment and follow up for 5 years.
HBV DNA <2000IU/ml and undetectable
Measured: 24 weeks post-treatment and follow up for 5 years.
ALT normalization
Measured: 24 weeks post-treatment and long-term follow-up
Sustained response
Measured: 5 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startJun 2013
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepaititis BStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henry LY Chan, Chinese University of Hong Kong
- Investigators
- Henry LY Chan, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068365
- Sponsor's protocol ID
- ML28486
- Status last verified
- Jul 2019
- First submitted
- 28 Jan 2014
- Last updated
- 31 Jul 2019
- Results posted
- No
Publications
Sung JJ, Tsoi KK, Wong VW, Li KC, Chan HL. Meta-analysis: Treatment of hepatitis B infection reduces risk of hepatocellular carcinoma. Aliment Pharmacol Ther. 2008 Nov 1;28(9):1067-77. doi: 10.1111/j.1365-2036.2008.03816.x. Epub 2008 Jul 24.
PubMed 18657133European Association For The Study Of The Liver. EASL clinical practice guidelines: Management of chronic hepatitis B virus infection. J Hepatol. 2012 Jul;57(1):167-85. doi: 10.1016/j.jhep.2012.02.010. Epub 2012 Mar 20. No abstract available.
PubMed 22436845Fung J, Lai CL, Tanaka Y, Mizokami M, Yuen J, Wong DK, Yuen MF. The duration of lamivudine therapy for chronic hepatitis B: cessation vs. continuation of treatment after HBeAg seroconversion. Am J Gastroenterol. 2009 Aug;104(8):1940-6; quiz 1947. doi: 10.1038/ajg.2009.200. Epub 2009 May 19.
PubMed 19455108Liang Y, Jiang J, Su M, Liu Z, Guo W, Huang X, Xie R, Ge S, Hu J, Jiang Z, Zhu M, Wong VW, Chan HL. Predictors of relapse in chronic hepatitis B after discontinuation of anti-viral therapy. Aliment Pharmacol Ther. 2011 Aug;34(3):344-52. doi: 10.1111/j.1365-2036.2011.04738.x. Epub 2011 Jun 14.
PubMed 21671967Wong VW, Wong GL, Yan KK, Chim AM, Chan HY, Tse CH, Choi PC, Chan AW, Sung JJ, Chan HL. Durability of peginterferon alfa-2b treatment at 5 years in patients with hepatitis B e antigen-positive chronic hepatitis B. Hepatology. 2010 Jun;51(6):1945-53. doi: 10.1002/hep.23568.
PubMed 20209602Marcellin P, Bonino F, Lau GK, Farci P, Yurdaydin C, Piratvisuth T, Jin R, Gurel S, Lu ZM, Wu J, Popescu M, Hadziyannis S; Peginterferon alfa-2a in HBeAg-negative Chronic Hepatitis B Study Group. Sustained response of hepatitis B e antigen-negative patients 3 years after treatment with peginterferon alpha-2a. Gastroenterology. 2009 Jun;136(7):2169-2179.e1-4. doi: 10.1053/j.gastro.2009.03.006. Epub 2009 Mar 19.
PubMed 19303414Song BC, Suh DJ, Lee HC, Chung YH, Lee YS. Hepatitis B e antigen seroconversion after lamivudine therapy is not durable in patients with chronic hepatitis B in Korea. Hepatology. 2000 Oct;32(4 Pt 1):803-6. doi: 10.1053/jhep.2000.16665.
PubMed 11003626Dienstag JL, Cianciara J, Karayalcin S, Kowdley KV, Willems B, Plisek S, Woessner M, Gardner S, Schiff E. Durability of serologic response after lamivudine treatment of chronic hepatitis B. Hepatology. 2003 Apr;37(4):748-55. doi: 10.1053/jhep.2003.50117.
PubMed 12668966Ryu SH, Chung YH, Choi MH, Kim JA, Shin JW, Jang MK, Park NH, Lee HC, Lee YS, Suh DJ. Long-term additional lamivudine therapy enhances durability of lamivudine-induced HBeAg loss: a prospective study. J Hepatol. 2003 Oct;39(4):614-9. doi: 10.1016/s0168-8278(03)00394-5.
PubMed 12971973van Nunen AB, Hansen BE, Suh DJ, Lohr HF, Chemello L, Fontaine H, Heathcote J, Song BC, Janssen HL, de Man RA, Schalm SW. Durability of HBeAg seroconversion following antiviral therapy for chronic hepatitis B: relation to type of therapy and pretreatment serum hepatitis B virus DNA and alanine aminotransferase. Gut. 2003 Mar;52(3):420-4. doi: 10.1136/gut.52.3.420.
PubMed 12584227
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Trial of 48-week Peginterferon Alfa-2a (PEGASYS) to Assess the Sustained Response of Chronic Hepatitis B Patients With HBeAg Seroconversion on Nucleot(s)Ide Analogue Therapy
- ClinicalTrials.gov ID
- NCT02068365
- Acronym / sponsor ID
- ML28486
- Conditions
- Chronic Hepaititis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 21 Feb 2014 (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.
This is a multi-center, single-arm, open-label study on the virological response of chronic HBV infection to pegyinterferon-alfa-2a among patients who achieved HBeAg seroconversion on nucleos(t)ide analogue (NA) treatment. The primary endpoint of this study is to investigate the sustained response (HBeAg seroconversion with HBV DNA <2000 IU/ml) to peginterferon at 24 weeks after the end of treatment.
Detailed description
Chronic hepatitis B is the commonest cause of liver cirrhosis and hepatocellular carcinoma in Hong Kong. Treatment with interferon and nucleos(t)ide analogues (NA) can reduce the risk of HCC. NA is the commonest used medication in Hong Kong. However, most patients require long-term treatment and premature drug cessation may lead to hepatitis relapse.
Under the current regional guidelines, patients who have positive hepatitis B e antigen (HBeAg) treated by NA can consider stopping treatment if HBeAg seroconversion has developed for at least 12 months. However, up to 30-50% of patients may develop virological relapse and/or HBeAg reversion after cessation of treatment. On the other hand, interferon-based treatment has a much more durable response. HBeAg seroconversion is maintained in 80% of patients after successful treatment with peginterferon. Upon long-term follow-up, peginterferon-treated patients are also more likely to achieve hepatitis B surface antigen (HBsAg) seroclearance, a condition closest to a cure of chronic hepatitis B.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pegyinterferon-alfa-2a | Other | Drug: Pegyinterferon-alfa-2aPegyinterferon-alfa-2a 180mcq weekly for 48 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male \& female patients >= 18 and < 70 years of age
- Positive HBeAg before starting NA treatment
- Treated by a single NA (lamivudine, adefovir, entecavir or tenofovir) for 6 months to 5 years
- Developed HBeAg seroconversion (HBeAg negative and ant-HBe negative) with undetectable HBV DNA by PCR based assay on NA treatment.
- Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug. Additionally, all females must be using reliable contraception during the study and for 3 months after treatment completion
Key exclusion criteria (28 listed)
- Evidence of decompensated liver disease (Childs B-C), hepato-cellular carcinoma, pre-existing severe depression or other psychiatric disease, significant cardiac disease, significant renal disease, seizure disorders or severe retinopathy.
- received telbivudine as the antiviral therapy or have received more than one NA in the past.
- received interferon or peginterferon treatment in the past.
- received antiviral therapy for any systemic anti-viral, anti-neoplastic or immuno-modulatory treatment (including supraphysiologic doses of steroids and radiation) within the past 6 months.
- Positive test at screening for anti-HIV, anti-HCV.
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 |
|---|---|---|
| Pegyinterferon-alfa-2aPegyinterferon-alfa-2a 180mcq weekly for 48 weeks | Drug | Pegyinterferon-alfa-2a |
Primary outcome
Sustained response (HBeAg seroconversion and HBV DNA <2000 IU/ml)
Time frame: 24 weeks post-treatment
5 secondary outcomes
HBeAg loss and seroconversion
Time frame: 24 weeks post-treatment and follow up for 5 years.
HBsAg loss and seroconversion
Time frame: 24 weeks post-treatment and follow up for 5 years.
HBV DNA <2000IU/ml and undetectable
Time frame: 24 weeks post-treatment and follow up for 5 years.
ALT normalization
Time frame: 24 weeks post-treatment and long-term follow-up
Sustained response
Time frame: 5 years post treatment
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 31 Jul 2019.
- Background: PubMed 18657133Sung JJ, Tsoi KK, Wong VW, Li KC, Chan HL. Meta-analysis: Treatment of hepatitis B infection reduces risk of hepatocellular carcinoma. Aliment Pharmacol Ther. 2008 Nov 1;28(9):1067-77. doi: 10.1111/j.1365-2036.2008.03816.x. Epub 2008 Jul 24.
- Background: PubMed 22436845European Association For The Study Of The Liver. EASL clinical practice guidelines: Management of chronic hepatitis B virus infection. J Hepatol. 2012 Jul;57(1):167-85. doi: 10.1016/j.jhep.2012.02.010. Epub 2012 Mar 20. No abstract available.
- Background: PubMed 19455108Fung J, Lai CL, Tanaka Y, Mizokami M, Yuen J, Wong DK, Yuen MF. The duration of lamivudine therapy for chronic hepatitis B: cessation vs. continuation of treatment after HBeAg seroconversion. Am J Gastroenterol. 2009 Aug;104(8):1940-6; quiz 1947. doi: 10.1038/ajg.2009.200. Epub 2009 May 19.
- Background: PubMed 21671967Liang Y, Jiang J, Su M, Liu Z, Guo W, Huang X, Xie R, Ge S, Hu J, Jiang Z, Zhu M, Wong VW, Chan HL. Predictors of relapse in chronic hepatitis B after discontinuation of anti-viral therapy. Aliment Pharmacol Ther. 2011 Aug;34(3):344-52. doi: 10.1111/j.1365-2036.2011.04738.x. Epub 2011 Jun 14.
- Background: PubMed 20209602Wong VW, Wong GL, Yan KK, Chim AM, Chan HY, Tse CH, Choi PC, Chan AW, Sung JJ, Chan HL. Durability of peginterferon alfa-2b treatment at 5 years in patients with hepatitis B e antigen-positive chronic hepatitis B. Hepatology. 2010 Jun;51(6):1945-53. doi: 10.1002/hep.23568.
- Background: PubMed 19303414Marcellin P, Bonino F, Lau GK, Farci P, Yurdaydin C, Piratvisuth T, Jin R, Gurel S, Lu ZM, Wu J, Popescu M, Hadziyannis S; Peginterferon alfa-2a in HBeAg-negative Chronic Hepatitis B Study Group. Sustained response of hepatitis B e antigen-negative patients 3 years after treatment with peginterferon alpha-2a. Gastroenterology. 2009 Jun;136(7):2169-2179.e1-4. doi: 10.1053/j.gastro.2009.03.006. Epub 2009 Mar 19.
- Background: PubMed 11003626Song BC, Suh DJ, Lee HC, Chung YH, Lee YS. Hepatitis B e antigen seroconversion after lamivudine therapy is not durable in patients with chronic hepatitis B in Korea. Hepatology. 2000 Oct;32(4 Pt 1):803-6. doi: 10.1053/jhep.2000.16665.
- Background: PubMed 12668966Dienstag JL, Cianciara J, Karayalcin S, Kowdley KV, Willems B, Plisek S, Woessner M, Gardner S, Schiff E. Durability of serologic response after lamivudine treatment of chronic hepatitis B. Hepatology. 2003 Apr;37(4):748-55. doi: 10.1053/jhep.2003.50117.
- Background: PubMed 12971973Ryu SH, Chung YH, Choi MH, Kim JA, Shin JW, Jang MK, Park NH, Lee HC, Lee YS, Suh DJ. Long-term additional lamivudine therapy enhances durability of lamivudine-induced HBeAg loss: a prospective study. J Hepatol. 2003 Oct;39(4):614-9. doi: 10.1016/s0168-8278(03)00394-5.
- Background: PubMed 12584227van Nunen AB, Hansen BE, Suh DJ, Lohr HF, Chemello L, Fontaine H, Heathcote J, Song BC, Janssen HL, de Man RA, Schalm SW. Durability of HBeAg seroconversion following antiviral therapy for chronic hepatitis B: relation to type of therapy and pretreatment serum hepatitis B virus DNA and alanine aminotransferase. Gut. 2003 Mar;52(3):420-4. doi: 10.1136/gut.52.3.420.
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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.
Henry LY Chan, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pegyinterferon-alfa-2a in people with Chronic Hepaititis B, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 28 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 Jul 2019. 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 Hong Kong. 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?
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?
Sustained response (HBeAg seroconversion and HBV DNA <2000 IU/ml) (time frame: 24 weeks post-treatment). 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 NCT02068365, which also lists 10 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 31 Jul 2019.