Trial · NCT02888106
Myrcludex B in Combination With Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients With Chronic Viral Hepatitis B With Delta-agent
NCT02888106, Phase 2, Completed, Hepatera Ltd.; results first posted 2021-02-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Myrcludex B in Combination With Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients With Chronic Viral Hepatitis B With Delta-agent. Trials, record NCT02888106. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02888106
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Myrcludex B in Combination With Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients With Chronic Viral Hepatitis B With Delta-agent
- NCT number
- NCT02888106
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 90 participants, actual
- Lead sponsor
- Hepatera Ltd.
- Conditions
- Chronic Viral Hepatitis B With Delta-agent
- Interventions
- Myrcludex B, PEG IFN alfa-2a, Tenofovir
- First posted
- 2016-09-02
- Last updated
- 2021-04-30
- Results first posted
- 2021-02-25
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients With Negative HDV RNA by PCR | 72 weeks | Negativation of HDV RNA by PCR (undetectable HDV RNA) at Week 72 (end of follow-up period) |
| Secondary | Percentage of Patients With Negative HDV RNA by PCR | 24 and 48 weeks | Percentage of patients with negative HDV RNA by PCR (undetectable HDV RNA) at Weeks 24 and 48 |
| Secondary | Percentage of Patients With Normalized ALT | 24, 48 and 72 weeks | Percentage of patients with normalized ALT at Weeks 24, 48 and 72. ALT normalisation was defined as having an ALT value within the normal range (≤31 U/L for females and ≤41 U/L for males) |
| Secondary | Percentage of Patients With Combined Response | 24, 48 and 72 weeks | Combined response is defined as negative HDV RNA and ALT normalization at Weeks 24, 48, and 72. The criteria for combined response were HDV RNA value below LLoD (where LLoD=10 IU/ml) and ALT within normal range (≤31 U/L for females and ≤41 U/L for males) |
| Secondary | Percentage of Patients With HВsAg Response | 24, 48 and 72 weeks | HВsAg response was defined as HBsAg negativation or \> 1 log10 IU/mL decline from baseline. |
| Secondary | Percentage of Patients With HBsAg Negativation | 48 and 72 weeks | Undetectable HВsAg with appearance of HbsAg antibodies or without it. |
| Secondary | Percentage of Patients With Negative HBV DNA by PCR | 24, 48 and 72 weeks | Percentage of patients with undetectable HBV DNA by PCR at Weeks 24, 48 and 72 |
| Secondary | The Intensity of Liver Fibrosis Based on Results of Transient Elastometry of Liver at Weeks 48 and 72. | 48 and 72 weeks | Change in liver stiffness and intensity of liver fibrosis based on results of transient elastometry of liver at weeks 48 and 72. |
| Secondary | Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment | 72 weeks | Change (improvement/ worsening) in fibrosis and histological activity stage according to the liver biopsy study results from baseline to post-treatment 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. |
| Secondary | Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region). | 48 and 72 weeks | Molecular analyses of relative HDV RNA expression, relative HBV pregenomic expression, relative total HBV RNA expression (X region), relative HBV RNA expression (S region) from baseline to post-treatment. \*Biopsy post treatment performed at Week 48 for arm D:MXB 2mg and arm F:MXB 5mg bid + Tenofovir, and performed at Week 72 for arms A:PEG-IFN, B:MXB 2mg + PEG-IFN, C:MXB 5mg + PEG-IFN and arm E:MXB 10mg + PEG-IFN. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients With Negative HDV RNA by PCR | 72 weeks | FAS | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With Negative HDV RNA by PCR | 24 and 48 weeks | FAS | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With Normalized ALT | 24, 48 and 72 weeks | FAS | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With Combined Response | 24, 48 and 72 weeks | FAS | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With HВsAg Response | 24, 48 and 72 weeks | FAS | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With HBsAg Negativation | 48 and 72 weeks | According to SAP Section 7.1.5 - Handling of missing data. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With Negative HBV DNA by PCR | 24, 48 and 72 weeks | Percentage of participants | NUMBER | |
| SECONDARY | The Intensity of Liver Fibrosis Based on Results of Transient Elastometry of Liver at Weeks 48 and 72. | 48 and 72 weeks | FAS | kPa | MEAN |
| SECONDARY | Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment | 72 weeks | FAS | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region). | 48 and 72 weeks | FAS | Relative value | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group324
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients With Negative HDV RNA by PCR | Arm A | 0 | 95% Confidence Interval 0.0 to 21.8 | Percentage of participants | |
| Percentage of Patients With Negative HDV RNA by PCR | Arm B | 53.3 | 95% Confidence Interval 26.6 to 78.7 | Percentage of participants | |
| Percentage of Patients With Negative HDV RNA by PCR | Arm C | 26.7 | 95% Confidence Interval 7.8 to 55.1 | Percentage of participants | |
| Percentage of Patients With Negative HDV RNA by PCR | Arm D | 6.7 | 95% Confidence Interval 0.2 to 31.9 | Percentage of participants | |
| Percentage of Patients With Negative HDV RNA by PCR | Arm E | 6.7 | 95% Confidence Interval 0.2 to 31.9 | Percentage of participants | |
| Percentage of Patients With Negative HDV RNA by PCR | Arm F | 33.3 | 95% Confidence Interval 11.8 to 61.6 | Percentage of participants | |
| Percentage of Patients With Negative HDV RNA by PCR | Arm A | Week 24 | 6.7 | 95% Confidence Interval 0.2 to 31.9 | Percentage of participants |
| Percentage of Patients With Negative HDV RNA by PCR | Arm B | Week 24 | 60.0 | 95% Confidence Interval 32.3 to 83.7 | Percentage of participants |
| Percentage of Patients With Negative HDV RNA by PCR | Arm C | Week 24 | 60.0 | 95% Confidence Interval 32.3 to 83.7 | Percentage of participants |
| Percentage of Patients With Negative HDV RNA by PCR | Arm D | Week 24 | 13.3 | 95% Confidence Interval 1.7 to 40.5 | Percentage of participants |
1 to 10 of 324Source ClinicalTrials.gov
See all 324 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A | 15 | |
| Overall Study | STARTED | Arm B | 15 | |
| Overall Study | STARTED | Arm C | 15 | |
| Overall Study | STARTED | Arm D | 15 | |
| Overall Study | STARTED | Arm E | 15 | |
| Overall Study | STARTED | Arm F | 15 | |
| Overall Study | COMPLETED | Arm A | 10 | |
| Overall Study | COMPLETED | Arm B | 13 | |
| Overall Study | COMPLETED | Arm C | 15 | |
| Overall Study | COMPLETED | Arm D | 13 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events822
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 | 5 | 15 | 18 |
| other | Total bile acids increased | Investigations | Arm B | 10 | 15 | 21 |
| other | Total bile acids increased | Investigations | Arm C | 9 | 15 | 31 |
| other | Total bile acids increased | Investigations | Arm D | 12 | 15 | 22 |
| other | Total bile acids increased | Investigations | Arm E | 15 | 15 | 45 |
| other | Total bile acids increased | Investigations | Arm F | 15 | 15 | 53 |
| other | ALT increased | Investigations | Arm A | 5 | 15 | 11 |
| other | ALT increased | Investigations | Arm B | 5 | 15 | 9 |
| other | ALT increased | Investigations | Arm C | 6 | 15 | 11 |
| other | ALT increased | Investigations | Arm D | 8 | 15 | 8 |
1 to 10 of 822Source ClinicalTrials.gov
See all 822 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A | 0 | 15 |
| Total, all-cause mortality | Arm B | 0 | 15 |
| Total, all-cause mortality | Arm C | 0 | 15 |
| Total, all-cause mortality | Arm D | 0 | 15 |
| Total, all-cause mortality | Arm E | 0 | 15 |
| Total, all-cause mortality | Arm F | 0 | 15 |
| Total, other adverse events | Arm A | 13 | 15 |
| Total, other adverse events | Arm B | 14 | 15 |
| Total, other adverse events | Arm C | 14 | 15 |
| Total, other adverse events | Arm D | 15 | 15 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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.
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.
GET https://conductscience.org/api/trials/v1/NCT02888106
GET https://conductscience.org/api/trials/v1/NCT02888106/results?page=2