Chronic Hepatitis c Genotype 1Phase 2NCT04246723

Efficacy and Safety of All-Oral Combination of Narlaprevir/Ritonavir and Sofosbuvir in Treatment-naïve Patients With Chronic Hepatitis C Genotype 1

A Phase 2 study testing Narlaprevir, Ritonavir and Sofosbuvir in people with Chronic Hepatitis c Genotype 1, run by R-Pharm at 5 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Multicenter, open-label, phase II safety and efficacy study of all-oral combination of narlaprevir/ritonavir and sofosbuvir in Treatment-naïve Patients with Chronic Hepatitis C Genotype 1. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Chronic Hepatitis c Genotype 1
What is being tested?: Narlaprevir, Ritonavir and Sofosbuvir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 85 participants
Where: 5 sitesRussia
Study dates: 6 May 2019to 12 Aug 2020
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Are willing and able to provide written informed consent.
Have confirmed chronic HCV infection as documented by:
positive anti-HCV antibody (Ab) test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline/Day 1 visit
Have HCV genotype 1 at screening as determined by the Central Laboratory. Any nondefinitive results must exclude the subject from study participation.
Minimum HCV-RNA level of ≥ 10,000 IU at baseline;
Treatment-naive patients to be enrolled into 8 week cohort must have HCV-RNA level <1,000,000 IU/L at baseline;

Show all 42Show fewer

No evidence of cirrhosis; availability at Baseline of at least one of the following tests negative results:
Liver biopsy within 2 years of screening showing absence of cirrhosis
Fibroscan® with a result of ≤ 12.5 kilopascal (kPa) within 6 months of baseline/Day1
FibroTest® score of ≤ 0.48 AND Aspartate aminotransferase (AST)-to-Platelet Ratio Index (APRI) of ≤ 1 performed during screening
In the absence of a definitive diagnosis of the presence or absence of cirrhosis by the above criteria, a liver biopsy was required. Liver biopsy results supersede the results obtained by Fibroscan® or FibroTest®
Have a screening electrocardiogram (ECG) without clinically significant abnormalities (P wave < 0.1 s; PQ interval 0,12-0,2 s; QRS complex 0,06-0,1 s; QT interval 0,35-0,49 s).
Must have the following laboratory parameters at screening:
alanine aminotransferase (ALT) ≤ 10 x the upper limit of normal (ULN)
AST ≤ 10 x ULN
Hemoglobin ≥ 12g/dL for male, ≥ 11g/dL for female subjects
Platelets ≥ 50,000cells/mm^3 (for patients in 8-week study treatment group - ≥ 150,000 cells/mm3)
International normalized ratio (INR) ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
Albumin ≥ 3 g/dL;
Direct bilirubin ≤ 1.5 x ULN;
Hemoglobin A1c (HbA1c) ≤10%;
Creatinine clearance (CLcr) ≥ 60 mL/min, as calculated by the Cockcroft-Gault equation.
Have not been treated with any investigational drug or device within 30 days of the screening visit.
A female subject is eligible to enter the study if it is confirmed that she is:
Not pregnant or nursing;
Of nonchildbearing potential (i.e., women who have had a hysterectomy, both ovaries removed, or medically documented ovarian failure, or are postmenopausal women >50 years of age with cessation [for ≥ 12 months ] of previously occurring menses), or
Of childbearing potential (i.e., women who had not had a hysterectomy, both ovaries removed, or medically documented ovarian failure). Women ≤ 50 years of age with amenorrhea are considered to be of childbearing potential. These women must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the baseline/Day 1 visit prior to enrollment. They must also agree to one of the following from the screening until 6 months after last dose of the investigational drugs:
Complete abstinence from intercourse. Periodic abstinence from intercourse (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not permitted.
Consistent and correct use of 1 of the following methods of birth control listed below in addition to a male partner who correctly uses a condom from the date of screening until 6 months after the last dose of the investigational drugs. Women of childbearing potential must not rely on hormone-containing contraceptives as a form of birth control during the study. Female subjects using a hormone-containing contraceptive prior to screening must stop their contraceptive regimen use from the date of screening until 6 months after their last dose of investigational drugs.
intrauterine device (IUD) with a failure rate of < 1 %;
female barrier method: cervical cap or diaphragm with spermicidal agent
tubal sterilization
vasectomy in male partner
All male study participants must agree to consistently and correctly use a condom, while their female partner agrees to use either 1 of the nonhormonal methods of birth control listed above or a hormone-containing contraceptive listed below, from the date of screening until 6 months after their last dose of investigational drugs:
implants of levonorgestrel
injectable progesterone
oral contraceptives (either combined or progesterone only)
contraceptive vaginal ring
transdermal contraceptive patch
Male subjects must agree to refrain from sperm donation for at least 6 months after the last dose of investigational drugs.
Are in generally good health as determined by the investigator.
Are able to comply with the dosing instructions for study drug administration and are able to complete the study schedule of assessments.

Who cannot join

Had prior exposure to Interferon (IFN), ribavirin (RBV), or other approved or experimental Direct-acting Antivirals (DAA) targeting the HCV.
Had prior exposure to amiodarone within 24 months before the screening
Are pregnant or nursing female or male with pregnant female partner.
Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, α1-antitrypsin deficiency, cholangitis).
Are infected with hepatitis B virus (HBV) or human immunodeficiency virus(HIV).
Have history of malignancy diagnosed or treated within 5 years; subjects under evaluation for malignancy are not eligible.

Show all 15Show fewer

Have chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent > 10 mg/day).
Have clinically relevant drug or alcohol abuse within 12 months of screening. A positive drug screen must exclude subjects unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by the investigator.
Have excessive alcohol consumption, defined as more than 3 drinks on any single day and more than 7 drinks per week for females, and > than 4 drinks on any single day and more than 14 drinks per week for males.
Have history of solid organ transplantation.
Have history of clinically significant illness or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol by Investigators' opinion.
Have history of a gastrointestinal disorder (or postoperative condition) that can interfere with the absorption of the study drug.
Have history of difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
Usage of any prohibited concomitant medications as described in the protocol (Appendix 1 - list of drugs with expected drug-drug interactions due to concomitant ritonavir usage)
Have known hypersensitivity to the study investigational medicinal product, the metabolites, or formulation excipients.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Russia5 sites

FBIS CSRI of Epidemiology of Federal Service on Customers
Moscow, 111123
FSIS FRC of food and biotechnology
Moscow, 115446
SBEI HPE MSMDU n.a. A.I. Evdokimov of Ministry of Health of Russia
Moscow, 125367
FSBI HEI HPE Military Medical Academy n.a. S.M. Kirov
Saint Petersburg, 193163
SPb SBIH Center on preventiomn and treatment of AIDS and infectional deseases
Saint Petersburg

Other trials in Russia

About this study

Multicenter, open-label, phase II safety and efficacy study of all-oral combination of narlaprevir/ritonavir and sofosbuvir in Treatment-naïve Patients with Chronic Hepatitis C Genotype 1.

Read the detailed description

Two patient cohorts were anticipated in this study:

Cohort A: 60 treatment-naive patients were enrolled into narlaprevir/ritonavir/sofosbuvir treatment for 12 weeks.
Cohort B: (exploratory): 25 treatment-naive patients with low viral load (HCV RNA<1000000 IU/L) were enrolled into narlaprevir/ritonavir/sofosbuvir treatment for 8 weeks.

The enrollment of 25 treatment-naïve patients with low viral load into 8 week cohort started after completion of enrollment of 60 treatment-naive patients into 12 week cohort.

The study included 3 time periods:

Screening period with duration up to 2 weeks during which study eligibility was confirmed.
Active treatment period (for 12 or 8 weeks): patients in the Cohort A were receiving study therapy with narlaprevir/ritonavir/sofosbuvir for 12 weeks, in the Cohort B - during 8 weeks. If a patient had virologic breakthrough while receiving therapy, discontinuation of antiviral treatment was advised with appropriate clinical follow-up.
Follow-up period during which patients did not receive any study medication. The duration of the follow-up period after the end of study treatment was 24 weeks.

Overall, each patient had been participating in the study for approximately up to 38 weeks from the time the patient signed the Informed Consent Form through the final visit.

If a patient had a screening failure, but was rescreened and subsequently enrolled, the reason for the original screening failure must have been documented in the source documents. A new subject Identification number (ID) was assigned to the patient.

The recruitment period in this study was planned to be up to 6 months. The total period of the study was anticipated to be approximately 1 year 3 months.

The patient was considered to be completed the study upon the completion of the last protocol specified visit. For those patients who did not complete the study, patient participation was considered terminated upon the completion of the last visit or contact (e.g., phone contact with the investigator).

It was estimated that 85 patients meeting inclusion/exclusion criteria would be recruited from approximately 6 clinical sites in Russia.

Conditions: Chronic Hepatitis c Genotype 1
Being tested: Narlaprevir, Ritonavir, Sofosbuvir
Keywords: hepatitis, HCV, antiviral
Medical subject headings: Hepatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NarlaprevirDrug
100 mg oval shaped, concave, yellow film-coated tablets taken as 200 mg per os once daily. 28 tabs/36 tabs/ 56 tabs in bottle.
RitonavirDrug
100 mg tablets taken as 100 mg per os once daily. 30 tablets in bottle
SofosbuvirDrug
400 mg yellow, capsule-shaped film-coated tablets debossed with "GSI" on one side and "7977" on the other side, taken as 400 mg per os once daily. 28 tablets in bottle.

Study groups in NCT04246723
Study group	Role	What they receive
Cohort A (Narlaprevir + Ritonavir + Sofosbuvir for 12 weeks)	Experimental	All of enrolled patients receive equal study therapy with Narlaprevir 200 mg Once a day (QD)/Ritonavir 100 mg QD/Sofosbuvir 400 mg QD orally for 12 weeks. Narlaprevir should be taken with ritonavir and food and should be taken at approximately the same morning time each day. Sofosbuvir can be taken with or without meals. Receives: Drug: Narlaprevir; Drug: Ritonavir; Drug: Sofosbuvir
Cohort B (Narlaprevir + Ritonavir + Sofosbuvir for 8 weeks)	Experimental	All of enrolled patients receive equal study therapy with Narlaprevir 200 mg QD (once daily)/Ritonavir 100 mg QD/Sofosbuvir 400 mg QD orally for 8 weeks. Narlaprevir should be taken with ritonavir and food and should be taken at approximately the same morning time each day. Sofosbuvir can be taken with or without meals. Receives: Drug: Narlaprevir; Drug: Ritonavir; Drug: Sofosbuvir

What is being measured

The primary outcome is the main question the study is designed to answer.

The proportion of patients achieved Sustained Virologic Response (SVR12) in treatment-naïve patients cohort, received study therapy during 12 weeks.
SVR12 - Undetectable HCV ( Hepatitis C Virus) RNA ( Ribonucleic Acid) by Lower limit Of Detection (LOD) 12 weeks following the end of treatment. LOD for HCV RNA <15 IU/mL
Measured: Week 12 of follow-up period (SVR12) - week 24 of the study

Secondary outcomes (5)

The proportion of patients who achieved the Sustained Virological Response 24 weeks after the end of treatment (SVR24) in 12-week cohort
HCV RNA undetectable by LOD; for 12-week cohort patients
Measured: 24 weeks after the end of the treatment or week 36 of the study
The proportion of patients achieved the End of treatment response (ETR) by LOD
HCV RNA <LOD at the treatment end;
Measured: Baseline and week 12 of the study (cohort A) or week 8 of the study (cohort B)
The proportion of patients who achieved the Sustained Virological Response 4 weeks after the end of treatment (SVR4) by LOD
HCV RNA <LOD 4 weeks after the end of treatment
Measured: 4 weeks after the end of treatment - week 16 of the study for cohort A and week 12 of the study for cohort B
The proportion of patients received 12 weeks of study treatment who developed viral breakthrough
applicable for cohort A patients only; viral breakthrough defined as greater than or equal to 1 log10 increase in HCV-RNA above nadir, or detectable HCV-RNA, while on treatment after an initial drop below detection in 12-week cohort. Viral breakthrough is an unsatisfactory therapeutic effect. in this case discontinuation of antiviral treatment is advised with appropriate clinical follow-up. Viral breakthrough will be summarized by patient cohort and treatment regimen. The number and proportion of patients achieving undetectable HCV RNA at each time point will be summarized. Time to breakthrough will be estimated using the Kaplan - Meier method if applicable
Measured: week 12 of the study
The proportion of patients received 12 weeks of study treatment who developed relapse
applicable for cohort A patients only; relapse presence is defined as HCV RNA undetectable by LOD at the end of treatment with subsequent detectable HCV RNA at the end of the follow-up period (week 12) in 12-week cohort;
Measured: week 12 of the study and week 24 of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 May 201912 Aug 2020

First posted29 Jan 2020
Study start6 May 2019
Primary completion8 Apr 2020
Study completion12 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Hepatitis c Genotype 1Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04246723
Sponsor's protocol ID: CJ05013053
Status last verified: Oct 2022
First submitted: 27 Jan 2020
Last updated: 31 Oct 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of All-Oral Combination of Narlaprevir/Ritonavir and Sofosbuvir in Treatment-naïve Patients With Chronic Hepatitis C Genotype 1
ClinicalTrials.gov ID: NCT04246723
Acronym / sponsor ID: CJ05013053
Conditions: Chronic Hepatitis c Genotype 1
Keywords: hepatitis, HCV, antiviral
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 85 participants (actual)
Lead sponsor: R-PharmIndustry (pharma, biotech, devices)
Collaborators: Almedis, Scientific Center EFiS, ChromSystemsLab
Study start: 6 May 2019 (actual)
Primary completion: 8 Apr 2020 (actual)
Study completion: 12 Aug 2020 (actual)
First posted: 29 Jan 2020 (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.

Multicenter, open-label, phase II safety and efficacy study of all-oral combination of narlaprevir/ritonavir and sofosbuvir in Treatment-naïve Patients with Chronic Hepatitis C Genotype 1.

Detailed description

Two patient cohorts were anticipated in this study:

Cohort A: 60 treatment-naive patients were enrolled into narlaprevir/ritonavir/sofosbuvir treatment for 12 weeks.
Cohort B: (exploratory): 25 treatment-naive patients with low viral load (HCV RNA<1000000 IU/L) were enrolled into narlaprevir/ritonavir/sofosbuvir treatment for 8 weeks.

The enrollment of 25 treatment-naïve patients with low viral load into 8 week cohort started after completion of enrollment of 60 treatment-naive patients into 12 week cohort.

The study included 3 time periods:

Screening period with duration up to 2 weeks during which study eligibility was confirmed.
Active treatment period (for 12 or 8 weeks): patients in the Cohort A were receiving study therapy with narlaprevir/ritonavir/sofosbuvir for 12 weeks, in the Cohort B - during 8 weeks. If a patient had virologic breakthrough while receiving therapy, discontinuation of antiviral treatment was advised with appropriate clinical follow-up.
Follow-up period during which patients did not receive any study medication. The duration of the follow-up period after the end of study treatment was 24 weeks.

Overall, each patient had been participating in the study for approximately up to 38 weeks from the time the patient signed the Informed Consent Form through the final visit.

The recruitment period in this study was planned to be up to 6 months. The total period of the study was anticipated to be approximately 1 year 3 months.

It was estimated that 85 patients meeting inclusion/exclusion criteria would be recruited from approximately 6 clinical sites in Russia.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort A (Narlaprevir + Ritonavir + Sofosbuvir for 12 weeks)	Experimental	Drug: Narlaprevir, Drug: Ritonavir, Drug: SofosbuvirAll of enrolled patients receive equal study therapy with Narlaprevir 200 mg Once a day (QD)/Ritonavir 100 mg QD/Sofosbuvir 400 mg QD orally for 12 weeks. Narlaprevir should be taken with ritonavir and food and should be taken at approximately the same morning time each day. Sofosbuvir can be taken with or without meals.
Cohort B (Narlaprevir + Ritonavir + Sofosbuvir for 8 weeks)	Experimental	Drug: Narlaprevir, Drug: Ritonavir, Drug: SofosbuvirAll of enrolled patients receive equal study therapy with Narlaprevir 200 mg QD (once daily)/Ritonavir 100 mg QD/Sofosbuvir 400 mg QD orally for 8 weeks. Narlaprevir should be taken with ritonavir and food and should be taken at approximately the same morning time each day. Sofosbuvir can be taken with or without meals.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (42 listed)

Are willing and able to provide written informed consent.
Have confirmed chronic HCV infection as documented by:
positive anti-HCV antibody (Ab) test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline/Day 1 visit
Have HCV genotype 1 at screening as determined by the Central Laboratory. Any nondefinitive results must exclude the subject from study participation.
Minimum HCV-RNA level of ≥ 10,000 IU at baseline;

Key exclusion criteria (15 listed)

Had prior exposure to Interferon (IFN), ribavirin (RBV), or other approved or experimental Direct-acting Antivirals (DAA) targeting the HCV.
Had prior exposure to amiodarone within 24 months before the screening
Are pregnant or nursing female or male with pregnant female partner.
Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, α1-antitrypsin deficiency, cholangitis).
Are infected with hepatitis B virus (HBV) or human immunodeficiency virus(HIV).

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
Narlaprevir100 mg oval shaped, concave, yellow film-coated tablets taken as 200 mg per os once daily. 28 tabs/36 tabs/ 56 tabs in bottle.	Drug	Cohort A (Narlaprevir + Ritonavir + Sofosbuvir for 12 weeks), Cohort B (Narlaprevir + Ritonavir + Sofosbuvir for 8 weeks)
Ritonavir100 mg tablets taken as 100 mg per os once daily. 30 tablets in bottle	Drug	Cohort A (Narlaprevir + Ritonavir + Sofosbuvir for 12 weeks), Cohort B (Narlaprevir + Ritonavir + Sofosbuvir for 8 weeks)
Sofosbuvir400 mg yellow, capsule-shaped film-coated tablets debossed with "GSI" on one side and "7977" on the other side, taken as 400 mg per os once daily. 28 tablets in bottle.	Drug	Cohort A (Narlaprevir + Ritonavir + Sofosbuvir for 12 weeks), Cohort B (Narlaprevir + Ritonavir + Sofosbuvir for 8 weeks)

Primary outcome

The proportion of patients achieved Sustained Virologic Response (SVR12) in treatment-naïve patients cohort, received study therapy during 12 weeks.
Time frame: Week 12 of follow-up period (SVR12) - week 24 of the study
SVR12 - Undetectable HCV ( Hepatitis C Virus) RNA ( Ribonucleic Acid) by Lower limit Of Detection (LOD) 12 weeks following the end of treatment. LOD for HCV RNA <15 IU/mL

5 secondary outcomes

The proportion of patients who achieved the Sustained Virological Response 24 weeks after the end of treatment (SVR24) in 12-week cohort
Time frame: 24 weeks after the end of the treatment or week 36 of the study
The proportion of patients achieved the End of treatment response (ETR) by LOD
Time frame: Baseline and week 12 of the study (cohort A) or week 8 of the study (cohort B)
The proportion of patients who achieved the Sustained Virological Response 4 weeks after the end of treatment (SVR4) by LOD
Time frame: 4 weeks after the end of treatment - week 16 of the study for cohort A and week 12 of the study for cohort B
The proportion of patients received 12 weeks of study treatment who developed viral breakthrough
Time frame: week 12 of the study
The proportion of patients received 12 weeks of study treatment who developed relapse
Time frame: week 12 of the study and week 24 of the study

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 Oct 2022.

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.

Mikhail Samsonov study director

R-Pharm

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Narlaprevir, Ritonavir and Sofosbuvir in people with Chronic Hepatitis c Genotype 1, run by R-Pharm at 5 sites in Russia.

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 42 inclusion and 15 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 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Russia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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?

The proportion of patients achieved Sustained Virologic Response (SVR12) in treatment-naïve patients cohort, received study therapy during 12 weeks. (time frame: Week 12 of follow-up period (SVR12) - week 24 of the study). 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 NCT04246723.

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 Oct 2022.