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Myrcludex B vs Entecavir in Patients With HBeAg Negative Chronic Hepatitis B | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Myrcludex B vs Entecavir in Patients With HBeAg Negative Chronic Hepatitis B

A Phase 1b/2a Randomized, Open-label Clinical Trial of Daily Myrcludex B Versus Entecavir in Patients With HBeAg Negative Chronic Hepatitis B

NCT02881008•Hepatera Ltd.

View on ClinicalTrials.gov

Summary

A randomized, open-label multicentre clinical trial of daily Myrcludex B versus entecavir in patients with HBeAg negative chronic hepatitis B.

Detailed Description

This is a randomized, open-label multicentre clinical trial of daily Myrcludex B versus entecavir in patients with HBeAg negative chronic hepatitis B. Accounting for screen-outs about 76 patients will be screened and 48 of them will be randomized into 6 treatment groups: Arm A (8 patients): Myrcludex B 0.5 mg / day / sc / 12 weeks Arm B (8 patients): Myrcludex B 1 mg / day / sc / 12 weeks Arm C (8 patients): Myrcludex B 2 mg / day / sc / 12 weeks Arm D (8 patients): Entecavir 0.5 mg / day / orally / 24 weeks Arm E (8 patients): Myrcludex B 5 mg / day / sc / 12 weeks Arm F (8 patients): Myrcludex B 10 mg / day / sc / 24 weeks The study consists of screening period up to 28 days (Day -28 -1); baseline visit (Day 0), treatment period up to 12 weeks for groups A-C, E and 24 weeks for groups D, F; follow-up period up to 12 weeks for groups A-C, E, F.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 18-65 years inclusive at the time of giving of written informed consent for study participation.
•2. Chronic hepatitis B defined by the presence of HBsAg for at least 6 months prior to screening period.
•3. Liver biopsy performed within one year prior to screening or during screening period.
•4. Alanine aminotransferase (ALT) ≥1.5 x ULN and ≤ 6 x ULN. If ALT level during screening period is ≥1 ULN the patient can be included in the study after obtaining the sponsor's approval and if the following conditions are met :
•* evidence of inflammation such as lymphocyte infiltration confirmed by liver biopsy performed within the 6 months prior to the inclusion in the study,
•* and/or the patient has a history of elevated ALT levels of ≥1.5 ULN during the 12 months prior to screening period.
•5. HBeAg negative and anti-HBeAg positive.
•6. HBV DNA ≥ 104 copies/mL.
•7. All women of childbearing potential must have a negative urine pregnancy test prior to enrolment.
•8. Women must:
+7 more criteria

Exclusion Criteria

•1. Decompensated liver disease (Child-Pugh-Score \>6).
•2. Any sign of liver cirrhosis (histological, ultra sound, biochemical).
•3. Co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV.
•4. ALT \> 6 ULN.
•5. Creatinine clearance \< 60 mL/min.
•6. Total bilirubin \> 2 mg/dL.
•7. Pre-treatment with nucleoside-analogues (lamivudine, telbivudine, entecavir) less than 6 months prior to the first dosing of the investigational medicinal products. Pre-treatment with nucleotide-analogues and interferons is allowed.
•8. History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC, such as suspicious foci on imaging studies or elevated serum alpha-fetoprotein (AFP) levels. In patients with such findings, HCC will be ruled-out prior to screening for the present study.
•9. One or more additional known primary or secondary causes of liver disease, other than hepatitis B (e.g., alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson's Disease, other congenital or metabolic conditions affecting the liver, e.g. congestive heart failure or other severe cardiopulmonary disease). Patients with Gilbert's syndrome and Dubin-Johnson syndrome, two benign disorders associated with low-grade hyperbilirubinemia can be enrolled into the trial.
•10. History of clinically evident pancreatitis.
+8 more criteria

Locations (9)

SBEI of Higher Professional Education "South Ural State Medical university" of the MoH of the RF

Chelyabinsk, Russia

1-st MMU n.a. I.M. Sechenov based in Moscow State-Owned Health Care Institution "Infectious Clinical Hospital № 2 of Moscow Healthcare Department"

Moscow, Russia

FSBI of Higher Education "People's Friendship University"

Moscow, Russia

FSBHI "Central Clinical Hospital RAS"

Moscow, Russia

LLC "Clinical Hospital of Tsentrosoyuz"

Moscow, Russia

SPb SBHI "The Center for Prevention and Control of AIDS and Infectious Diseases"

Saint Petersburg, Russia

SPb SIH "Clinical Centre of Infectious Diseases Named After S.P. Botkin"

Saint Petersburg, Russia

Medical Company "Hepatolog" LLC

Samara, Russia

SBIH "Stavropol Regional Clinical Hospital"

Stavropol, Russia

Key Dates

Start Date

November 14, 2012

Primary Completion Date

October 4, 2014

Completion Date

October 4, 2014

Last Updated

September 19, 2018

Enrollment

ACTUAL participants

Conditions

Chronic Hepatitis B

Interventions

Entecavir

DRUG

Myrcludex B

DRUG

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

NCT06671093

Chronic Hep BChronic Hepatitis b+2 more

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Myrcludex B vs Entecavir in Patients With HBeAg Negative Chronic Hepatitis B

Inclusion Criteria

Exclusion Criteria

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

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