Chronic Hepatitis BPhase 1NCT05017116
A Single and Repeated Dose Escalation of RBD1016 in Subjects with Chronic Hepatitis B Virus (HBV) Infection
A Phase 1 study testing RBD1016 and Entecavir in people with Chronic Hepatitis B, run by Suzhou Ribo Life Science Co. Ltd. at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-controlled, single (Part A) and repeated dose (Part B) escalation, phase I clinical study to evaluate the safety, pharmacokinetics (PK) and preliminary pharmacodynamics (PD) of RBD1016 in subjects with chronic HBV infection. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- RBD1016 and Entecavir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 9 Aug 2021to 25 Oct 2023
- Phase
- Phase 1
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects who voluntarily participate in this clinical trial, are able to correctly understand and have signed the informed consent in writing;
- Male or female volunteer aged 18-55 years (inclusive);
- Body Mass Index (BMI) of 18-30 kg/m2 (inclusive);
- Subjects with chronic HBV infection, including immunotolerant subjects, treatment naïve subjects and treated subjects.
- Ability to cooperate with study staff and comply with the study requirements and follow the protocol-specified procedures.
Who cannot join
- Subjects with liver diseases other than hepatitis B, including hepatitis C, hemochromatosis, primary sclerosing cholangitis; alcoholic, drug-related or autoimmune liver diseases; primary liver cancer and indeterminate nodules on liver imaging test;
- A history or manifestations of liver decompensation (e.g. Child-Pugh Class B or C, or ascites, gastrointestinal bleeding, hepatic encephalopathy or spontaneous bacterial peritonitis, etc.);
- Transient elastography at screening revealing FibroScan value ≥ 9 kPa or liver biopsy evidencing hepatic fibrosis within 24 months;
- The following laboratory findings: total serum bilirubin> 2×ULN; serum alpha-fetoprotein>50μg/L; serum albumin <3.5g/dL; international normalized ratio (INR)> 1.25; serum creatinine > 1.5×ULN; any laboratory outliers of clinical significance that in the investigator's opinion may interfere with the interpretation of efficacy or safety data;
- 12-lead ECG abnormalities with clinical significance;
- Pregnant or lactating women or women of child-bearing potential who are unwilling to take effective contraception throughout the course of the study (refer to Appendix 3 for details);
- Other factors that in the investigator's opinion would make it inappropriate for the subject to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single and Repeated Dose Escalation, Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics and Preliminary Pharmacodynamics of RBD1016 in Subjects with Chronic Hepatitis B Virus (HBV) Infection
This is a randomized, double-blind, placebo-controlled, single (Part A) and repeated dose (Part B) escalation, phase I clinical study to evaluate the safety, pharmacokinetics (PK) and preliminary pharmacodynamics (PD) of RBD1016 in subjects with chronic HBV infection.
Read the detailed description
The study consists of two parts. Part A is the single dose escalation study where subjects with chronic HBV infection will be assigned to receive single dose of RBD1016 or placebo . Part B is the multiple dose escalation study where subjects with chronic HBV infection will be assigned to receive two doses of RBD1016 or placebo.
- Conditions
- Chronic Hepatitis B
- Being tested
- RBD1016, Placebo, Entecavir
- Keywords
- CHB, chronic hepatitis B infection
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBD1016Drug
Also called RBD1016 injection
subcutaneous injection
PlaceboDrug
subcutaneous injection
EntecavirDrug
Take orally.
| Study group | Role | What they receive |
|---|---|---|
| Part A，single dose group | Experimental | Subjects will receive single dose RBD1016/placebo on D1 combined with antiviral drugs during the study period. Receives: Drug: RBD1016; Drug: Placebo; Drug: Entecavir |
| Part B, multiple dose group | Experimental | Subjects will receive two doses of RBD1016/placebo on D1 and D29 combined with antiviral drugs during the study period. Receives: Drug: RBD1016; Drug: Placebo; Drug: Entecavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs) and serious adverse events (SAEs) within 28 days after treatment (Part A)
All reported AE terms will be coded using Medical Dictionary for Drug Regulatory Affairs (MedDRA).AEs and SAEs occurred throughout the course of the study will be evaluated and graded based on NCI-CTCAE V5.0.
Measured: up to 28 days
Adverse events (AEs) and serious adverse events (SAEs) within 28 days after the last treatment(Part B)
All reported AE terms will be coded using Medical Dictionary for Drug Regulatory Affairs (MedDRA).AEs and SAEs occurred throughout the course of the study will be evaluated and graded based on NCI-CTCAE V5.0.
Measured: up to 28 days
Secondary outcomes (34)
To draw the figure of HBsAg dynamic changes from baseline to Week 24 (Part A).
Electro chmiluminescence method will be used to detect hepatitis B surface antigen (HBsAg).
Measured: up to 24 weeks
To draw the figure of HBsAb dynamic changes from baseline to Week 24 (Part A).
Electro chmiluminescence method will be used to detect hepatitis B surface antibody (HBsAb).
Measured: up to 24 weeks
To draw the figure of HBeAg dynamic changes from baseline to Week 24 (Part A).
Electro chmiluminescence method will be used to detect hepatitis B e antigen (HBeAg).
Measured: up to 24 weeks
To draw the figure of HBeAb dynamic changes from baseline to Week 24 (Part A).
Electro chmiluminescence method will be used to detect hepatitis B e antibody (HBeAb).
Measured: up to 24 weeks
To draw the figure of HBcAb dynamic changes from baseline to Week 24 (Part A).
Electro chmiluminescence method will be used to detect hepatitis B core antibody (HBcAb).
Measured: up to 24 weeks
To draw the figure of HBcrAg dynamic changes from baseline to Week 24 (Part A).
Electro chmiluminescence method will be used to detect hepatitis B core-related antigen (HBcrAg).
Measured: up to 24 weeks
To draw the figure of HBV DNA dynamic changes from baseline to Week 24 (Part A).
PCR will be used to detect HBV DNA.
Measured: up to 24 weeks
To draw the figure of HBV RNA dynamic changes from baseline to Week 24 (Part A).
PCR will be used to detect HBV RNA.
Measured: up to 24 weeks
To draw the figure of peripheral blood T lymphocyte subsets dynamic changes from baseline to Week 24 (Part A).
Flow Cytometry will be used to detect peripheral blood T lymphocyte subsets.
Measured: up to 24 weeks
To draw the figure of B cell dynamic changes from baseline to Week 24 (Part A).
Flow Cytometry will be used to detect B cell count.
Measured: up to 24 weeks
To characterize the pharmacokinetic parameter Cmax (Part A).
PCR will be ued to detect Maximum concentration (Cmax) and PhoenixWinNonlin software (V8.0 or higher) will be used to calculate the PK parameters.
Measured: up to 85 days
To characterize the pharmacokinetic parameter Tmax (Part A).
Time to maximum concentration (Tmax) will be calculated by PhoenixWinNonlin software (V8.0 or higher) will be used to calculate the PK parameter.
Measured: up to 85 days
To characterize the pharmacokinetic parameter AUC0-t (Part A).
Area under the concentration-time curve from 0 to the collection time t (AUC0-t) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
Measured: up to 85 days
To characterize the pharmacokinetic parameter AUC0-inf (Part A).
Area under the concentration-time curve from 0 to infinity (AUC0-inf) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
Measured: up to 85 days
To characterize the pharmacokinetic parameter t1/2 (Part A).
Half-Life (t1/2) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
Measured: up to 85 days
To characterize the pharmacokinetic parameter Vd (Part A).
Apparent volume of distribution (Vd) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
Measured: up to 85 days
To characterize the pharmacokinetic parameter CL/F (Part A)
Clearance (CL/F) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
Measured: up to 85 days
To draw the figure of HBsAg dynamic changes from baseline to Week 24 (Part B).
Electro chmiluminescence method will be used to detect hepatitis B surface antigen (HBsAg).
Measured: up to 24 weeks
To draw the figure of HBsAb dynamic changes from baseline to Week 24 (Part B).
Electro chmiluminescence method will be used to detect hepatitis B surface antibody (HBsAb).
Measured: up to 24 weeks
To draw the figure of HBeAg dynamic changes from baseline to Week 24 (Part B).
Electro chmiluminescence method will be used to detect hepatitis B e antigen (HBeAg).
Measured: up to 24 weeks
To draw the figure of HBeAb dynamic changes from baseline to Week 24 (Part B).
Electro chmiluminescence method will be used to detect hepatitis B e antibody (HBeAb).
Measured: up to 24 weeks
To draw the figure of HBcAb dynamic changes from baseline to Week 24 (Part B).
Electro chmiluminescence method will be used to detect hepatitis B core antibody (HBcAb).
Measured: up to 24 weeks
To draw the figure of HBcrAg dynamic changes from baseline to Week 24 (Part B).
Electro chmiluminescence method will be used to detect hepatitis B core-related antigen (HBcrAg).
Measured: up to 24 weeks
To draw the figure of HBV DNA dynamic changes from baseline to Week 24 (Part B).
PCR will be used to detect HBV DNA.
Measured: up to 24 weeks
To draw the figure of HBV RNA dynamic changes from baseline to Week 24 (Part B).
PCR will be used to detect HBV RNA.
Measured: up to 24 weeks
To draw the figure of peripheral blood T lymphocyte subsets dynamic changes from baseline to Week 24 (Part B).
Flow Cytometry will be used to detect peripheral blood T lymphocyte subsets.
Measured: up to 24 weeks
To draw the figure of B cell dynamic changes from baseline to Week 24 (Part B).
Flow Cytometry will be used to detect B cell count.
Measured: up to 24 weeks
To characterize the pharmacokinetic parameter Cmax (Part B).
PCR will be ued to detect Maximum concentration (Cmax) and PhoenixWinNonlin software (V8.0 or higher) will be used to calculate the PK parameters.
Measured: up to 113 days
To characterize the pharmacokinetic parameter Tmax (Part B).
Time to maximum concentration (Tmax) will be calculated by PhoenixWinNonlin software (V8.0 or higher) will be used to calculate the PK parameter.
Measured: up to 113 days
To characterize the pharmacokinetic parameter AUC0-t (Part B).
Area under the concentration-time curve from 0 to the collection time t (AUC0-t) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
Measured: up to 113 days
To characterize the pharmacokinetic parameter AUC0-inf (Part B).
Area under the concentration-time curve from 0 to infinity (AUC0-inf) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
Measured: up to 113 days
To characterize the pharmacokinetic parameter t1/2 (Part B).
Half-Life (t1/2) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
Measured: up to 113 days
To characterize the pharmacokinetic parameter Vd (Part B).
Apparent volume of distribution (Vd) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
Measured: up to 113 days
To characterize the pharmacokinetic parameter CL/F (Part B).
Clearance (CL/F) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
Measured: up to 113 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start9 Aug 2021
- Primary completion25 Oct 2023
- Study completion25 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Ribo Life Science Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Walter Seto, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017116
- Sponsor's protocol ID
- RBHB1103-HK
- Status last verified
- Oct 2023
- First submitted
- 10 Aug 2021
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single and Repeated Dose Escalation, Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics and Preliminary Pharmacodynamics of RBD1016 in Subjects with Chronic Hepatitis B Virus (HBV) Infection
- ClinicalTrials.gov ID
- NCT05017116
- Acronym / sponsor ID
- RBHB1103-HK
- Conditions
- Chronic Hepatitis B
- Keywords
- CHB, chronic hepatitis B infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Suzhou Ribo Life Science Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 25 Oct 2023 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 23 Aug 2021 (actual)
- 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 randomized, double-blind, placebo-controlled, single (Part A) and repeated dose (Part B) escalation, phase I clinical study to evaluate the safety, pharmacokinetics (PK) and preliminary pharmacodynamics (PD) of RBD1016 in subjects with chronic HBV infection.
Detailed description
The study consists of two parts. Part A is the single dose escalation study where subjects with chronic HBV infection will be assigned to receive single dose of RBD1016 or placebo . Part B is the multiple dose escalation study where subjects with chronic HBV infection will be assigned to receive two doses of RBD1016 or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A，single dose group | Experimental | Drug: RBD1016, Drug: Placebo, Drug: EntecavirSubjects will receive single dose RBD1016/placebo on D1 combined with antiviral drugs during the study period. |
| Part B, multiple dose group | Experimental | Drug: RBD1016, Drug: Placebo, Drug: EntecavirSubjects will receive two doses of RBD1016/placebo on D1 and D29 combined with antiviral drugs during the study period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects who voluntarily participate in this clinical trial, are able to correctly understand and have signed the informed consent in writing;
- Male or female volunteer aged 18-55 years (inclusive);
- Body Mass Index (BMI) of 18-30 kg/m2 (inclusive);
- Subjects with chronic HBV infection, including immunotolerant subjects, treatment naïve subjects and treated subjects.
- Ability to cooperate with study staff and comply with the study requirements and follow the protocol-specified procedures.
Key exclusion criteria (7 listed)
- Subjects with liver diseases other than hepatitis B, including hepatitis C, hemochromatosis, primary sclerosing cholangitis; alcoholic, drug-related or autoimmune liver diseases; primary liver cancer and indeterminate nodules on liver imaging test;
- A history or manifestations of liver decompensation (e.g. Child-Pugh Class B or C, or ascites, gastrointestinal bleeding, hepatic encephalopathy or spontaneous bacterial peritonitis, etc.);
- Transient elastography at screening revealing FibroScan value ≥ 9 kPa or liver biopsy evidencing hepatic fibrosis within 24 months;
- The following laboratory findings: total serum bilirubin> 2×ULN; serum alpha-fetoprotein>50μg/L; serum albumin <3.5g/dL; international normalized ratio (INR)> 1.25; serum creatinine > 1.5×ULN; any laboratory outliers of clinical significance that in the investigator's opinion may interfere with the interpretation of efficacy or safety data;
- 12-lead ECG abnormalities with clinical significance;
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 |
|---|---|---|
| RBD1016Also: RBD1016 injectionsubcutaneous injection | Drug | Part A，single dose group, Part B, multiple dose group |
| Placebosubcutaneous injection | Drug | Part A，single dose group, Part B, multiple dose group |
| EntecavirTake orally. | Drug | Part A，single dose group, Part B, multiple dose group |
Primary outcome
Adverse events (AEs) and serious adverse events (SAEs) within 28 days after treatment (Part A)
Time frame: up to 28 days
All reported AE terms will be coded using Medical Dictionary for Drug Regulatory Affairs (MedDRA).AEs and SAEs occurred throughout the course of the study will be evaluated and graded based on NCI-CTCAE V5.0.
Adverse events (AEs) and serious adverse events (SAEs) within 28 days after the last treatment(Part B)
Time frame: up to 28 days
All reported AE terms will be coded using Medical Dictionary for Drug Regulatory Affairs (MedDRA).AEs and SAEs occurred throughout the course of the study will be evaluated and graded based on NCI-CTCAE V5.0.
34 secondary outcomes
To draw the figure of HBsAg dynamic changes from baseline to Week 24 (Part A).
Time frame: up to 24 weeks
To draw the figure of HBsAb dynamic changes from baseline to Week 24 (Part A).
Time frame: up to 24 weeks
To draw the figure of HBeAg dynamic changes from baseline to Week 24 (Part A).
Time frame: up to 24 weeks
To draw the figure of HBeAb dynamic changes from baseline to Week 24 (Part A).
Time frame: up to 24 weeks
To draw the figure of HBcAb dynamic changes from baseline to Week 24 (Part A).
Time frame: up to 24 weeks
To draw the figure of HBcrAg dynamic changes from baseline to Week 24 (Part A).
Time frame: up to 24 weeks
To draw the figure of HBV DNA dynamic changes from baseline to Week 24 (Part A).
Time frame: up to 24 weeks
To draw the figure of HBV RNA dynamic changes from baseline to Week 24 (Part A).
Time frame: up to 24 weeks
To draw the figure of peripheral blood T lymphocyte subsets dynamic changes from baseline to Week 24 (Part A).
Time frame: up to 24 weeks
To draw the figure of B cell dynamic changes from baseline to Week 24 (Part A).
Time frame: up to 24 weeks
To characterize the pharmacokinetic parameter Cmax (Part A).
Time frame: up to 85 days
To characterize the pharmacokinetic parameter Tmax (Part A).
Time frame: up to 85 days
To characterize the pharmacokinetic parameter AUC0-t (Part A).
Time frame: up to 85 days
To characterize the pharmacokinetic parameter AUC0-inf (Part A).
Time frame: up to 85 days
To characterize the pharmacokinetic parameter t1/2 (Part A).
Time frame: up to 85 days
To characterize the pharmacokinetic parameter Vd (Part A).
Time frame: up to 85 days
To characterize the pharmacokinetic parameter CL/F (Part A)
Time frame: up to 85 days
To draw the figure of HBsAg dynamic changes from baseline to Week 24 (Part B).
Time frame: up to 24 weeks
To draw the figure of HBsAb dynamic changes from baseline to Week 24 (Part B).
Time frame: up to 24 weeks
To draw the figure of HBeAg dynamic changes from baseline to Week 24 (Part B).
Time frame: up to 24 weeks
To draw the figure of HBeAb dynamic changes from baseline to Week 24 (Part B).
Time frame: up to 24 weeks
To draw the figure of HBcAb dynamic changes from baseline to Week 24 (Part B).
Time frame: up to 24 weeks
To draw the figure of HBcrAg dynamic changes from baseline to Week 24 (Part B).
Time frame: up to 24 weeks
To draw the figure of HBV DNA dynamic changes from baseline to Week 24 (Part B).
Time frame: up to 24 weeks
To draw the figure of HBV RNA dynamic changes from baseline to Week 24 (Part B).
Time frame: up to 24 weeks
To draw the figure of peripheral blood T lymphocyte subsets dynamic changes from baseline to Week 24 (Part B).
Time frame: up to 24 weeks
To draw the figure of B cell dynamic changes from baseline to Week 24 (Part B).
Time frame: up to 24 weeks
To characterize the pharmacokinetic parameter Cmax (Part B).
Time frame: up to 113 days
To characterize the pharmacokinetic parameter Tmax (Part B).
Time frame: up to 113 days
To characterize the pharmacokinetic parameter AUC0-t (Part B).
Time frame: up to 113 days
To characterize the pharmacokinetic parameter AUC0-inf (Part B).
Time frame: up to 113 days
To characterize the pharmacokinetic parameter t1/2 (Part B).
Time frame: up to 113 days
To characterize the pharmacokinetic parameter Vd (Part B).
Time frame: up to 113 days
To characterize the pharmacokinetic parameter CL/F (Part B).
Time frame: up to 113 days
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 6 Dec 2024.
- Individual participant dataSharing planned: No
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Chronic Hepatitis B
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.
Walter Seto principal investigator
The 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 1 study testing RBD1016 and Entecavir in people with Chronic Hepatitis B, run by Suzhou Ribo Life Science Co. Ltd. at 1 site in China.
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 7 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 6 Dec 2024. 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 China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Adverse events (AEs) and serious adverse events (SAEs) within 28 days after treatment (Part A) (time frame: up to 28 days). 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 6 Dec 2024.