Trial · NCT02637999
Myrcludex B Plus Pegylated Interferon-alpha-2a in Patients With HBeAg Negative HBV/HDV Co-infection
NCT02637999, Phase 1, Phase 2, Completed, Hepatera Ltd.; results first posted 2018-04-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Myrcludex B Plus Pegylated Interferon-alpha-2a in Patients With HBeAg Negative HBV/HDV Co-infection. Trials, record NCT02637999. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02637999
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Myrcludex B Plus Pegylated Interferon-alpha-2a in Patients With HBeAg Negative HBV/HDV Co-infection
- NCT number
- NCT02637999
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- Hepatera Ltd.
- Conditions
- Chronic Hepatitis D Infection
- Interventions
- PEG IFN alfa-2a, Myrcludex B
- First posted
- 2015-12-22
- Last updated
- 2018-04-13
- Results first posted
- 2018-04-13
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Hepatitis B Surface Antigen (HBsAg) Response at Week 12 of Therapy | Baseline and 12 weeks | HBsAg response was defined as serum HBsAg decline of at least 0.5 log IU/mL (or HBsAg negativation) at week 12 compared to baseline (including the patient with negative baseline level) |
| Secondary | Number of Participants With Hepatitis B Surface Antigen (HBsAg) Response at Week 24 of Therapy | Baseline and 24 weeks | HBsAg response was defined as serum HBsAg decline of at least 0.5 log IU/mL (or HBsAg negativation) at week 24 compared to baseline (including the patient with negative baseline level) |
| Secondary | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Response at Week 24 of Therapy | Baseline and 24 weeks | HBV DNA response was defined as persistent reduction of HBV DNA by \> 1 log IU/mL or negativation (including the patient with negative baseline level) |
| Secondary | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Response at Week 12 of Therapy | Baseline and 12 weeks | HBV DNA response was defined as persistent reduction of HBV DNA by \> 1 log IU/mL or negativation (including the patient with negative baseline level) |
| Secondary | Number of Participants With Hepatitis D Virus Ribonucleic Acid (HDV RNA) Response at Week 12 of Therapy | Baseline and 12 weeks | HDV RNA response was defined as persistent reduction of HDV RNA by \> 1 log IU/mL or negativation (including the patient with negative baseline level) |
| Secondary | Number of Participants With Hepatitis D Virus Ribonucleic Acid (HDV RNA) Response at Week 24 of Therapy | Baseline and 24 weeks | HDV RNA response was defined as persistent reduction of HDV RNA by \> 1 log IU/mL or negativation (including the patient with negative baseline level) |
| Secondary | Number of Participants With Biochemical Response at Week 12 of Therapy | Baseline and 12 weeks | Biochemical response was defined as normalization of ALT level as compared to baseline. |
| Secondary | Number of Participants With Biochemical Response at Week 24 of Therapy | Baseline and 24 weeks | Biochemical response was defined as normalization of ALT level as compared to baseline. |
| Secondary | Number of Participants With Covalently Closed Circular Deoxyribonucleic Acid (cccDNA) Response at Week 72 of Therapy | Baseline and 72 weeks for arm A and 48 weeks for arms B and C | Virological cccDNA response was defined as reduction of intrahepatic cccDNA by 0.5 log in comparison to baseline at the end of follow up. |
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 | Number of Participants With Hepatitis B Surface Antigen (HBsAg) Response at Week 12 of Therapy | Baseline and 12 weeks | For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Hepatitis B Surface Antigen (HBsAg) Response at Week 24 of Therapy | Baseline and 24 weeks | For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Response at Week 24 of Therapy | Baseline and 24 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Response at Week 12 of Therapy | Baseline and 12 weeks | For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Hepatitis D Virus Ribonucleic Acid (HDV RNA) Response at Week 12 of Therapy | Baseline and 12 weeks | For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Hepatitis D Virus Ribonucleic Acid (HDV RNA) Response at Week 24 of Therapy | Baseline and 24 weeks | For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Biochemical Response at Week 12 of Therapy | Baseline and 12 weeks | For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Biochemical Response at Week 24 of Therapy | Baseline and 24 weeks | For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Covalently Closed Circular Deoxyribonucleic Acid (cccDNA) Response at Week 72 of Therapy | Baseline and 72 weeks for arm A and 48 weeks for arms B and C | No data to be reported due to absence of biopsy data. Biopsy data are unavailable because analyses were not performed |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Hepatitis B Surface Antigen (HBsAg) Response at Week 12 of Therapy | MXB Then PEG IFN | 0 | Participants | ||
| Number of Participants With Hepatitis B Surface Antigen (HBsAg) Response at Week 12 of Therapy | MXB + PEG IFN Then PEG IFN | 0 | Participants | ||
| Number of Participants With Hepatitis B Surface Antigen (HBsAg) Response at Week 12 of Therapy | PEG IFN | 0 | Participants | ||
| Number of Participants With Hepatitis B Surface Antigen (HBsAg) Response at Week 24 of Therapy | MXB Then PEG IFN | 2 | Participants | ||
| Number of Participants With Hepatitis B Surface Antigen (HBsAg) Response at Week 24 of Therapy | MXB + PEG IFN Then PEG IFN | 1 | Participants | ||
| Number of Participants With Hepatitis B Surface Antigen (HBsAg) Response at Week 24 of Therapy | PEG IFN | 3 | Participants | ||
| Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Response at Week 24 of Therapy | MXB Then PEG IFN | 2 | Participants | ||
| Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Response at Week 24 of Therapy | MXB + PEG IFN Then PEG IFN | 6 | Participants | ||
| Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Response at Week 24 of Therapy | PEG IFN | 3 | Participants | ||
| Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Response at Week 12 of Therapy | MXB Then PEG IFN | 1 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MXB Then PEG IFN | 8 | |
| Overall Study | STARTED | MXB + PEG IFN Then PEG IFN | 8 | |
| Overall Study | STARTED | PEG IFN | 8 | |
| Overall Study | COMPLETED | MXB Then PEG IFN | 7 | |
| Overall Study | COMPLETED | MXB + PEG IFN Then PEG IFN | 6 | |
| Overall Study | COMPLETED | PEG IFN | 6 | |
| Overall Study | NOT COMPLETED | MXB Then PEG IFN | 1 | |
| Overall Study | NOT COMPLETED | MXB + PEG IFN Then PEG IFN | 2 | |
| Overall Study | NOT COMPLETED | PEG IFN | 2 |
Source ClinicalTrials.gov
Adverse events51
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 | Leucopenia | Blood and lymphatic system disorders | MXB Then PEG IFN | 7 | 8 | 16 |
| other | Leucopenia | Blood and lymphatic system disorders | MXB + PEG IFN Then PEG IFN | 7 | 8 | 11 |
| other | Leucopenia | Blood and lymphatic system disorders | PEG IFN | 7 | 8 | 17 |
| other | Neutropenia | Blood and lymphatic system disorders | MXB Then PEG IFN | 7 | 8 | 17 |
| other | Neutropenia | Blood and lymphatic system disorders | MXB + PEG IFN Then PEG IFN | 7 | 8 | 15 |
| other | Neutropenia | Blood and lymphatic system disorders | PEG IFN | 7 | 8 | 21 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | MXB Then PEG IFN | 6 | 8 | 21 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | MXB + PEG IFN Then PEG IFN | 5 | 8 | 14 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | PEG IFN | 6 | 8 | 20 |
| other | Anaemia | Blood and lymphatic system disorders | MXB Then PEG IFN | 2 | 8 | 2 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MXB Then PEG IFN | ||
| Total, all-cause mortality | MXB + PEG IFN Then PEG IFN | ||
| Total, all-cause mortality | PEG IFN | ||
| Total, other adverse events | MXB Then PEG IFN | 8 | 8 |
| Total, other adverse events | MXB + PEG IFN Then PEG IFN | 8 | 8 |
| Total, other adverse events | PEG IFN | 8 | 8 |
| Total, serious adverse events | MXB Then PEG IFN | 0 | 8 |
| Total, serious adverse events | MXB + PEG IFN Then PEG IFN | 0 | 8 |
| Total, serious adverse events | PEG IFN | 0 | 8 |
Source ClinicalTrials.gov
Papers6
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/NCT02637999
GET https://conductscience.org/api/trials/v1/NCT02637999/results?page=2