Trial · NCT03546621

A Multicenter, Open-label, Randomized Clinical Study to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination With Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients With Chronic Hepatitis D

NCT03546621, Phase 2, Completed, Hepatera Ltd.; results first posted 2019-12-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Multicenter, Open-label, Randomized Clinical Study to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination With Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients With Chronic Hepatitis D. Trials, record NCT03546621. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03546621

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Multicenter, Open-label, Randomized Clinical Study to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination With Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients With Chronic Hepatitis D
NCT number: NCT03546621
Status: Completed
Phases: Phase 2
Enrollment: 120 participants, actual
Lead sponsor: Hepatera Ltd.
Conditions: Chronic Hepatitis D Infection With Hepatitis B
Interventions: Myrcludex B, Myrcludex-B, Myrcludex-B, Tenofovir
First posted: 2018-06-06
Last updated: 2021-05-10
Results first posted: 2019-12-30

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	HDV RNA Response at Week 24	24 weeks	HDV RNA negativation or decrease by ≥2 log10 from baseline to Week 24
Secondary	Durability of HDV RNA Response	48 weeks	Durability of HDV RNA response to 24 weeks post treatment
Secondary	Combined Response: HDV RNA Response and Normal ALT at Treatment Week 24	24 weeks	Combined response: HDV RNA negativation or ≥2 log decline and normal ALT at treatment week 24
Secondary	Changes in ALT Values	24 and 48 weeks	Changes in ALT values at Week 24 and Week 48 compared to baseline.
Secondary	Change (Absence of Increase) in Fibrosis Marker	24 and 48 weeks	Change (absence of increase) in fibrosis marker: serum alpha-2-macroglobulin at Week 24 and Week 48 compared to baseline
Secondary	Change in Hepatitis B Surface Antigen	24 and 48 weeks	Changes in hepatitis B surface antigen (HBsAg) (defined as decline in HBsAg levels, disappearance of HBsAg and HBsAg seroconversion to anti-HBsAg) at week 24 and week 48 compared to baseline
Secondary	Change in HBV DNA Levels at Week 24 and Week 48 Compared to Baseline	24 and 48 weeks	Change in hepatitis B virus (HBV) DNA levels at Week 24 and Week 48 compared to baseline.
Secondary	Absence of a Fibrosis Progression According to the Findings of Transient Elastometry	24 weeks	Decrease in liver stiffness and absence of a fibrosis progression according to the findings of transient elastometry (fibroscan) at week 24 compared to baseline
Secondary	Number of Participants With Improvement of Histological Findings According to the Liver Biopsy Results	24 weeks	Change (improvement/ worsening) in fibrosis and histological activity stage according to the liver biopsy study results at week 24 compared to baseline. Liver fibrosis was evaluated by histological staging systems with stage 0 corresponding to absence of fibrosis and with the highest score (the last stage in all systems) corresponding to cirrhosis. Improvement is defined as a decrease of at least 1 point in histological staging systems; worsening is defined as an increase of at least 1 point. Data should be interpreted with caution due to low number of paired biopsies available.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	HDV RNA Response at Week 24	24 weeks	mITT	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Durability of HDV RNA Response	48 weeks	mITT	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Combined Response: HDV RNA Response and Normal ALT at Treatment Week 24	24 weeks	mITT	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Changes in ALT Values	24 and 48 weeks	mITT	U/L	MEAN
SECONDARY	Change (Absence of Increase) in Fibrosis Marker	24 and 48 weeks	mITT	g/L	MEAN
SECONDARY	Change in Hepatitis B Surface Antigen	24 and 48 weeks	mITT	IU/mL	MEAN
SECONDARY	Change in HBV DNA Levels at Week 24 and Week 48 Compared to Baseline	24 and 48 weeks	mITT	IU/mL	MEAN
SECONDARY	Absence of a Fibrosis Progression According to the Findings of Transient Elastometry	24 weeks	mITT	kPa	MEAN
SECONDARY	Number of Participants With Improvement of Histological Findings According to the Liver Biopsy Results	24 weeks	mITT	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group132

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
HDV RNA Response at Week 24	Arm A	Responder	15	Participants
HDV RNA Response at Week 24	Arm B	Responder	16	Participants
HDV RNA Response at Week 24	Arm C	Responder	23	Participants
HDV RNA Response at Week 24	Arm D	Responder	1	Participants
HDV RNA Response at Week 24	Arm A	Non-Responder	13	Participants
HDV RNA Response at Week 24	Arm B	Non-Responder	16	Participants
HDV RNA Response at Week 24	Arm C	Non-Responder	7	Participants
HDV RNA Response at Week 24	Arm D	Non-Responder	27	Participants
Durability of HDV RNA Response	Arm A	Response at Week 24 only	15	Participants
Durability of HDV RNA Response	Arm B	Response at Week 24 only	16	Participants

1 to 10 of 132Source ClinicalTrials.gov

See all 132 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A	28
Overall Study	STARTED	Arm B	32
Overall Study	STARTED	Arm C	30
Overall Study	STARTED	Arm D	28
Overall Study	COMPLETED	Arm A	28
Overall Study	COMPLETED	Arm B	29
Overall Study	COMPLETED	Arm C	28
Overall Study	COMPLETED	Arm D	25
Overall Study	NOT COMPLETED	Arm A	0
Overall Study	NOT COMPLETED	Arm B	3

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events464

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Total bile acids increased	Investigations	Arm A	8	28	12
other	Total bile acids increased	Investigations	Arm B	12	32	20
other	Total bile acids increased	Investigations	Arm C	15	30	24
other	Total bile acids increased	Investigations	Arm D	6	28	8
other	ALT increased	Investigations	Arm A	4	28	4
other	ALT increased	Investigations	Arm B	5	32	9
other	ALT increased	Investigations	Arm C	9	30	12
other	ALT increased	Investigations	Arm D	4	28	10
other	AST increased	Investigations	Arm A	3	28	3
other	AST increased	Investigations	Arm B	7	32	10

1 to 10 of 464Source ClinicalTrials.gov

See all 464 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A	0	28
Total, all-cause mortality	Arm B	0	32
Total, all-cause mortality	Arm C	0	30
Total, all-cause mortality	Arm D	0	28
Total, other adverse events	Arm A	18	28
Total, other adverse events	Arm B	19	32
Total, other adverse events	Arm C	21	30
Total, other adverse events	Arm D	13	28
Total, serious adverse events	Arm A	0	28
Total, serious adverse events	Arm B	3	32

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
36113537	DERIVED	PubMed
37120031	DERIVED	PubMed
38340811	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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GET https://conductscience.org/api/trials/v1/NCT03546621/results?page=2

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