Hepatitis BPhase 3HBRNNCT01369199
Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults With Chronic Hepatitis B
A Phase 3 study testing Entecavir and peginterferon in people with Hepatitis B, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 21 sites in 2 countries.
Trial summary
The investigators evaluated the safety and efficacy of a short lead-in course (8 weeks) of entecavir followed by combination of entecavir plus peginterferon alfa-2a for 40 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Entecavir and peginterferon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 21 sitesin 2 countries
- Study dates
- May 2012to 14 Feb 2017
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled in \& completed the baseline evaluation for NCT01263587 or completed the necessary components of NCT01263587 by the end of baseline visit.
- >18 years of age at the baseline visit (day 0). Patients >50 years of age at baseline will need to have a liver biopsy as standard of care with hepatic activity index (HAI) ≤3 \& Ishak fibrosis score ≤1 within 96 weeks prior to baseline visit.
- Documented chronic HBV infection as evidenced by detection of HBsAg in serum for ≥24 weeks prior to baseline visit OR at least one positive HBsAg \& negative anti-hepatitis B core (HBc) immunoglobulin (IgM) within 24 weeks prior to baseline visit OR at least one positive HBsAg \& two positive HBV DNA over a period of ≥24 weeks prior to baseline visit.
- Presence of HBeAg in serum at last screening visit within 6 weeks of baseline visit.
- Serum HBV DNA level >10˄7 IU/mL on at least two occasions at least 12 weeks apart during the 52 weeks before baseline visit. One of the two HBV DNA levels must be within 6 weeks of baseline visit.
- ALT levels persistently ≤45 U/L in males, ≤30 U/L in females (approx. 1.5 times the upper limit of normal (ULN) range) as documented by at least three values: one taken 28-52 weeks before baseline visit, one taken 6 to 24 weeks before the baseline visit, \& the final value within 6 weeks prior to baseline visit.
- No evidence of hepatocellular carcinoma (HCC) based upon alpha-fetoprotein (AFP) ≤20 ng/mL at screening visit (up to 6 weeks prior to baseline visit). a. Participants who meet American Association for the Study of Liver Diseases (AASLD) criteria for HCC surveillance must have negative liver imaging as shown by ultrasound, computerized tomography (CT) or magnetic resonance imaging (MRI) within 28 weeks prior to baseline visit. b. Participants with AFP >20 ng/mL must be evaluated clinically with additional imaging \& shown not to have HCC on CT or MRI before they can be enrolled.
Who cannot join
- History of hepatic decompensation
- Evidence of decompensated liver disease prior to or during screening, including direct bilirubin >0.5 mg/dL, international normalization ratio (INR) >1.5, or serum albumin <3.5 g/dL.
- Platelet count <120,000/mm3, hemoglobin <13 g/dL (males) or <12 g/dL (females), absolute neutrophil count < 1500 /mm3 (<1000/mm3 for African-Americans) at last screening visit.
- Previous treatment with medications that have established activity against HBV including interferon \& nucleos(t)ide analogs ≥24 weeks. Patients with <24 weeks of prior HBV treatment \& a wash-out period >24 weeks are not excluded.
- Known allergy or intolerance to study medications.
- Females who are pregnant or breastfeeding. Females of childbearing potential unable or unwilling to use a reliable method of contraception during the treatment period.
Show all 19Show fewer
- Renal insufficiency with calculated creatinine clearance <50 mL/min at screening.
- History of alcohol or drug abuse within 48 weeks of baseline visit.
- Previous liver or other organ transplantation (including engrafted bone marrow).
- Any other concomitant liver disease, including hepatitis C or D. Non-alcoholic fatty liver disease (NAFLD) with steatosis \&/or mild to moderate steatohepatitis is acceptable but NAFLD with severe steatohepatitis is exclusionary.
- Presence of anti-hepatitis D virus (HDV) or anti-hepatitis C virus (HCV) (unless HCV RNA negative) in serum on any occasion in the 144 weeks prior to baseline visit. Presence of anti-HIV (test completed within 6 weeks prior to baseline visit).
- Pre-existing psychiatric condition(s), including, but not limited to: current moderate or severe depression, history of depression requiring hospitalization within the past 10 years, history of suicidal or homicidal attempt within the past 10 years, history of severe psychiatric disorders as determined by a study physician.
- History of immune-mediated or cerebrovascular disease, chronic pulmonary or cardiac disease associated with functional limitation, retinopathy, uncontrolled thyroid disease, poorly controlled diabetes or uncontrolled seizure disorder, as determined by a study physician.
- Any medical condition that would, in the opinion of a study physician, be predicted to be exacerbated by therapy or that would limit study participation.
- Any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids or other immunosuppressive medications during the course of this study.
- Evidence of active or suspected malignancy, or a history of malignancy within the 144 weeks prior to baseline visit (except adequately treated carcinoma in situ or basal cell carcinoma of the skin).
- Expected need for ongoing use of any antivirals with activity against HBV during the course of the study.
- Concomitant use of complementary or alternative medications purported to have antiviral activity.
- Participation in any other clinical trial involving investigational drugs within 30 days of the baseline visit or intention to participate in another clinical trial involving investigational drugs during participation in this study.
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States20 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
NIH Clinical Center
Bethesda, Maryland, 20892
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of North Carolina
Chapel Hill, North Carolina, 27599
Baylor University Medical Center
Dallas, Texas, 75246
University of Texas Southwestern
Dallas, Texas, 75390
Duke University Medical Center
Durham, North Carolina, 27710
Queen's Medical Center
Honolulu, Hawaii, 96813
Cedars Sinai Medical Center
Los Angeles, California, 90048
University of California Los Angeles
Los Angeles, California, 90095
University of Minnesota
Minneapolis, Minnesota, 55446
Virginia Commonwealth University
Richmond, Virginia, 23498
Mayo Clinic
Rochester, Minnesota, 55905
California Pacific Medical Center
San Francisco, California, 94115
University of California San Francisco
San Francisco, California, 94143
Virginia Mason Medical Center
Seattle, Washington, 98101
University of Washington Medical Center
Seattle, Washington, 98105
Saint Louis University
St Louis, Missouri, 63104
Washington University
St Louis, Missouri, 63110
About this study
The investigators evaluated the safety and efficacy of a short lead-in course (8 weeks) of entecavir followed by combination of entecavir plus peginterferon alfa-2a for 40 weeks.
Read the detailed description
To determine the efficacy of treatment with 8 weeks of entecavir followed by 40 weeks of both entecavir and peginterferon in the treatment of chronic hepatitis B in hepatitis B "e" antigen (HBeAg) positive adults who are in the immune tolerant phase.
To evaluate safety and sustained responses after treatment with entecavir and peginterferon alfa-2a in the treatment of chronic hepatitis B in HBeAg positive adults who are in the immune tolerant phase.
A single arm treatment study of 8 weeks of entecavir followed by 40 weeks of both entecavir and peginterferon alfa-2a in adults with HBeAg-positive chronic hepatitis B with normal or near normal alanine aminotransferase (ALT) levels and high serum levels of hepatitis B virus (HBV) DNA ("immune tolerant" HBeAg-positive chronic hepatitis B). All participants followed for 48 weeks after treatment discontinuation (week 96 for those who completed treatment).
- Conditions
- Hepatitis B
- Being tested
- Entecavir and peginterferon
- Keywords
- Hepatitis B, Immune-tolerant hepatitis B, HBV
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entecavir and peginterferonDrug
Also called PEGASYS, peginterferon alfa 2a, Baraclude
Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon 180 µg sq weekly during weeks 9-48 of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Peginterferon and entecavir | Experimental | A combination of 8 weeks of entecavir followed by 40 weeks of both entecavir and peginterferon. Receives: Drug: Entecavir and peginterferon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With HBeAg Loss (Lack of Detectable HBeAg) AND HBV DNA ≤1,000 IU/mL
Lack of data was considered to be treatment failure.
Measured: End of follow-up (up to 96 weeks)
Incidence of Adverse Events (AEs) Per Person-Year of Observation
The number of AEs includes both AEs and Serious Adverse Events (SAEs). The incidence is calculated as the number of AEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.
Measured: From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)
Incidence of Serious Adverse Events (SAEs) Per Person-Year
The incidence is calculated as the number of SAEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.
Measured: From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)
Secondary outcomes (17)
Proportion of Participants With HBeAg Loss
Measured: End of treatment (up to 48 weeks)
Proportion of Participants With HBeAg Loss
Measured: End of follow-up (up to 96 weeks)
Proportion of Participants With HBeAg Seroconversion
Measured: End of treatment (up to 48 weeks)
Proportion of Participants With HBeAg Seroconversion
Measured: End of follow-up (up to 96 weeks)
Proportion of Participants With HBsAg Loss
Measured: End of treatment (up to 48 weeks)
Proportion of Participants With HBsAg Loss
Measured: End of follow-up (up to 96 weeks)
Proportion of Participants With HBsAg Seroconversion
Measured: End of treatment (up to 48 weeks)
Proportion of Participants With HBsAg Seroconversion
Measured: End of follow-up (up to 96 weeks)
Proportion of Participants With Alanine Aminotransferase (ALT) <45 U/L for Men, <30 U/L for Women
Measured: End of treatment (up to 48 weeks)
Proportion of Participants With ALT <45 U/L for Men, <30 U/L for Women
Measured: End of follow-up (up to 96 weeks)
Proportion of Participants With ALT Normalization (Men <30 U/L, Women <20 U/L)
Measured: End of treatment (up to 48 weeks)
Proportion of Participants With ALT Normalization (Men <30 U/L, Women <20 U/L)
Measured: End of follow-up (up to 96 weeks)
Proportion of Participants With HBV DNA ≤1000 IU/mL
Measured: End of treatment (up to 48 weeks)
Proportion of Participants With HBV DNA ≤1000 IU/mL
Measured: End of follow-up (up to 96 weeks)
Proportion of Participants With HBV DNA <20 IU/mL
Measured: End of treatment (up to 48 weeks)
Proportion of Participants With HBV DNA <20 IU/mL
Measured: End of follow-up (up to 96 weeks)
Absence of Detectable Antiviral Drug-resistance HBV Mutations
HBV drug resistance variant testing was performed at the CDC laboratory. The sequences of the HBV polymerase spanning nucleotide positions 311-1021 were determined by Sanger sequencing. Drug resistance mutations that were tested in this study included L80VI, L82M, T128N, W153Q, F166L, I169T, V173L, L180M, A181TV, T184ACFGILMS, V191T, A194T, A200V, S202ETV, M204IV, V207I, N236T, M250ILV, and G145R.
Measured: End of treatment (up to 48 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startMay 2012
- Primary completion14 Feb 2017
- Study completion14 Feb 2017
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 Hepatitis BStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Pittsburgh, National Center for Research Resources (NCRR)
- Responsible party
- Sponsor
- Investigators
- Averell Sherker, MD, Study chair, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Anna Lok, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369199
- Sponsor's protocol ID
- DK082864 HBRN IT Adult Trial
- Other IDs
- U01DK082916, U01DK082843, U01DK082863, U01DK082864, U01DK082866, U01DK082867, U01DK082871, U01DK082872
- Acronym
- HBRN
- Status last verified
- May 2022
- First submitted
- 6 Jun 2011
- Last updated
- 26 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data collected will be sent to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)-supported data repository.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT01369199
- Acronym / sponsor ID
- HBRN / DK082864 HBRN IT Adult Trial
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B, Immune-tolerant hepatitis B, HBV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- University of Pittsburgh, National Center for Research Resources (NCRR)
- Study start
- May 2012
- Primary completion
- 14 Feb 2017 (actual)
- Study completion
- 14 Feb 2017 (actual)
- First posted
- 8 Jun 2011 (estimated)
- Results
- Posted 3 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators evaluated the safety and efficacy of a short lead-in course (8 weeks) of entecavir followed by combination of entecavir plus peginterferon alfa-2a for 40 weeks.
Detailed description
To determine the efficacy of treatment with 8 weeks of entecavir followed by 40 weeks of both entecavir and peginterferon in the treatment of chronic hepatitis B in hepatitis B "e" antigen (HBeAg) positive adults who are in the immune tolerant phase.
To evaluate safety and sustained responses after treatment with entecavir and peginterferon alfa-2a in the treatment of chronic hepatitis B in HBeAg positive adults who are in the immune tolerant phase.
A single arm treatment study of 8 weeks of entecavir followed by 40 weeks of both entecavir and peginterferon alfa-2a in adults with HBeAg-positive chronic hepatitis B with normal or near normal alanine aminotransferase (ALT) levels and high serum levels of hepatitis B virus (HBV) DNA ("immune tolerant" HBeAg-positive chronic hepatitis B). All participants followed for 48 weeks after treatment discontinuation (week 96 for those who completed treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peginterferon and entecavir | Experimental | Drug: Entecavir and peginterferonA combination of 8 weeks of entecavir followed by 40 weeks of both entecavir and peginterferon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Enrolled in \& completed the baseline evaluation for NCT01263587 or completed the necessary components of NCT01263587 by the end of baseline visit.
- >18 years of age at the baseline visit (day 0). Patients >50 years of age at baseline will need to have a liver biopsy as standard of care with hepatic activity index (HAI) ≤3 \& Ishak fibrosis score ≤1 within 96 weeks prior to baseline visit.
- Documented chronic HBV infection as evidenced by detection of HBsAg in serum for ≥24 weeks prior to baseline visit OR at least one positive HBsAg \& negative anti-hepatitis B core (HBc) immunoglobulin (IgM) within 24 weeks prior to baseline visit OR at least one positive HBsAg \& two positive HBV DNA over a period of ≥24 weeks prior to baseline visit.
- Presence of HBeAg in serum at last screening visit within 6 weeks of baseline visit.
- Serum HBV DNA level >10˄7 IU/mL on at least two occasions at least 12 weeks apart during the 52 weeks before baseline visit. One of the two HBV DNA levels must be within 6 weeks of baseline visit.
Key exclusion criteria (19 listed)
- History of hepatic decompensation
- Evidence of decompensated liver disease prior to or during screening, including direct bilirubin >0.5 mg/dL, international normalization ratio (INR) >1.5, or serum albumin <3.5 g/dL.
- Platelet count <120,000/mm3, hemoglobin <13 g/dL (males) or <12 g/dL (females), absolute neutrophil count < 1500 /mm3 (<1000/mm3 for African-Americans) at last screening visit.
- Previous treatment with medications that have established activity against HBV including interferon \& nucleos(t)ide analogs ≥24 weeks. Patients with <24 weeks of prior HBV treatment \& a wash-out period >24 weeks are not excluded.
- Known allergy or intolerance to study medications.
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 |
|---|---|---|
| Entecavir and peginterferonAlso: PEGASYS, peginterferon alfa 2a, BaracludeEntecavir 0.5 mg daily orally for 48 weeks plus peginterferon 180 µg sq weekly during weeks 9-48 of treatment. | Drug | Peginterferon and entecavir |
Primary outcome
Proportion of Participants With HBeAg Loss (Lack of Detectable HBeAg) AND HBV DNA ≤1,000 IU/mL
Time frame: End of follow-up (up to 96 weeks)
Lack of data was considered to be treatment failure.
Incidence of Adverse Events (AEs) Per Person-Year of Observation
Time frame: From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)
The number of AEs includes both AEs and Serious Adverse Events (SAEs). The incidence is calculated as the number of AEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.
Incidence of Serious Adverse Events (SAEs) Per Person-Year
Time frame: From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)
The incidence is calculated as the number of SAEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.
17 secondary outcomes
Proportion of Participants With HBeAg Loss
Time frame: End of treatment (up to 48 weeks)
Proportion of Participants With HBeAg Loss
Time frame: End of follow-up (up to 96 weeks)
Proportion of Participants With HBeAg Seroconversion
Time frame: End of treatment (up to 48 weeks)
Proportion of Participants With HBeAg Seroconversion
Time frame: End of follow-up (up to 96 weeks)
Proportion of Participants With HBsAg Loss
Time frame: End of treatment (up to 48 weeks)
Proportion of Participants With HBsAg Loss
Time frame: End of follow-up (up to 96 weeks)
Proportion of Participants With HBsAg Seroconversion
Time frame: End of treatment (up to 48 weeks)
Proportion of Participants With HBsAg Seroconversion
Time frame: End of follow-up (up to 96 weeks)
Proportion of Participants With Alanine Aminotransferase (ALT) <45 U/L for Men, <30 U/L for Women
Time frame: End of treatment (up to 48 weeks)
Proportion of Participants With ALT <45 U/L for Men, <30 U/L for Women
Time frame: End of follow-up (up to 96 weeks)
Proportion of Participants With ALT Normalization (Men <30 U/L, Women <20 U/L)
Time frame: End of treatment (up to 48 weeks)
Proportion of Participants With ALT Normalization (Men <30 U/L, Women <20 U/L)
Time frame: End of follow-up (up to 96 weeks)
Proportion of Participants With HBV DNA ≤1000 IU/mL
Time frame: End of treatment (up to 48 weeks)
Proportion of Participants With HBV DNA ≤1000 IU/mL
Time frame: End of follow-up (up to 96 weeks)
Proportion of Participants With HBV DNA <20 IU/mL
Time frame: End of treatment (up to 48 weeks)
Proportion of Participants With HBV DNA <20 IU/mL
Time frame: End of follow-up (up to 96 weeks)
Absence of Detectable Antiviral Drug-resistance HBV Mutations
Time frame: End of treatment (up to 48 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All data collected will be sent to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)-supported data repository.
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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.
Averell Sherker, MD study chair
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Anna Lok, MD principal investigator
University of Michigan
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Entecavir and peginterferon in people with Hepatitis B, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 21 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 7 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: stopped early, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 3 Jul 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?
Proportion of Participants With HBeAg Loss (Lack of Detectable HBeAg) AND HBV DNA ≤1,000 IU/mL (time frame: End of follow-up (up to 96 weeks)). The study lists 3 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 26 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.