Trial Outcomes & Findings for Myrcludex B Plus Pegylated Interferon-alpha-2a in Patients With HBeAg Negative HBV/HDV Co-infection (NCT NCT02637999)
NCT ID: NCT02637999
Last Updated: 2018-04-13
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2018-04-13
Participant Flow
Participant milestones
| Measure |
MXB Then PEG IFN
Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
|
MXB + PEG IFN Then PEG IFN
Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks
|
PEG IFN
PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
7
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Myrcludex B Plus Pegylated Interferon-alpha-2a in Patients With HBeAg Negative HBV/HDV Co-infection
Baseline characteristics by cohort
| Measure |
MXB Then PEG IFN
n=8 Participants
Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
|
MXB + PEG IFN Then PEG IFN
n=8 Participants
Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks
|
PEG IFN
n=8 Participants
PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
38.3 years
STANDARD_DEVIATION 10.05 • n=5 Participants
|
33.0 years
STANDARD_DEVIATION 4.87 • n=7 Participants
|
42.1 years
STANDARD_DEVIATION 10.23 • n=5 Participants
|
37.8 years
STANDARD_DEVIATION 9.19 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Russia
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
24 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.
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)
Outcome measures
| Measure |
MXB Then PEG IFN
n=8 Participants
Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
|
MXB + PEG IFN Then PEG IFN
n=8 Participants
Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by pegINF 180mcg once weekly for 24 weeks
|
PEG IFN
n=8 Participants
PEG IFN alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
|
|---|---|---|---|
|
Number of Participants With Hepatitis B Surface Antigen (HBsAg) Response at Week 12 of Therapy
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.
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)
Outcome measures
| Measure |
MXB Then PEG IFN
n=8 Participants
Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
|
MXB + PEG IFN Then PEG IFN
n=8 Participants
Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by pegINF 180mcg once weekly for 24 weeks
|
PEG IFN
n=8 Participants
PEG IFN alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
|
|---|---|---|---|
|
Number of Participants With Hepatitis B Surface Antigen (HBsAg) Response at Week 24 of Therapy
|
2 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksHBV DNA response was defined as persistent reduction of HBV DNA by \> 1 log IU/mL or negativation (including the patient with negative baseline level)
Outcome measures
| Measure |
MXB Then PEG IFN
n=8 Participants
Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
|
MXB + PEG IFN Then PEG IFN
n=8 Participants
Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by pegINF 180mcg once weekly for 24 weeks
|
PEG IFN
n=8 Participants
PEG IFN alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
|
|---|---|---|---|
|
Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Response at Week 24 of Therapy
|
2 Participants
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.
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)
Outcome measures
| Measure |
MXB Then PEG IFN
n=8 Participants
Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
|
MXB + PEG IFN Then PEG IFN
n=8 Participants
Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by pegINF 180mcg once weekly for 24 weeks
|
PEG IFN
n=8 Participants
PEG IFN alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
|
|---|---|---|---|
|
Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Response at Week 12 of Therapy
|
1 Participants
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.
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)
Outcome measures
| Measure |
MXB Then PEG IFN
n=8 Participants
Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
|
MXB + PEG IFN Then PEG IFN
n=8 Participants
Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by pegINF 180mcg once weekly for 24 weeks
|
PEG IFN
n=8 Participants
PEG IFN alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
|
|---|---|---|---|
|
Number of Participants With Hepatitis D Virus Ribonucleic Acid (HDV RNA) Response at Week 12 of Therapy
|
4 Participants
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.
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)
Outcome measures
| Measure |
MXB Then PEG IFN
n=8 Participants
Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
|
MXB + PEG IFN Then PEG IFN
n=8 Participants
Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by pegINF 180mcg once weekly for 24 weeks
|
PEG IFN
n=8 Participants
PEG IFN alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
|
|---|---|---|---|
|
Number of Participants With Hepatitis D Virus Ribonucleic Acid (HDV RNA) Response at Week 24 of Therapy
|
7 Participants
|
7 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.
Biochemical response was defined as normalization of ALT level as compared to baseline.
Outcome measures
| Measure |
MXB Then PEG IFN
n=8 Participants
Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
|
MXB + PEG IFN Then PEG IFN
n=8 Participants
Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by pegINF 180mcg once weekly for 24 weeks
|
PEG IFN
n=8 Participants
PEG IFN alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
|
|---|---|---|---|
|
Number of Participants With Biochemical Response at Week 12 of Therapy
|
2 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.
Biochemical response was defined as normalization of ALT level as compared to baseline.
Outcome measures
| Measure |
MXB Then PEG IFN
n=8 Participants
Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
|
MXB + PEG IFN Then PEG IFN
n=8 Participants
Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by pegINF 180mcg once weekly for 24 weeks
|
PEG IFN
n=8 Participants
PEG IFN alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
|
|---|---|---|---|
|
Number of Participants With Biochemical Response at Week 24 of Therapy
|
6 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and 72 weeks for arm A and 48 weeks for arms B and CPopulation: No data to be reported due to absence of biopsy data. Biopsy data are unavailable because analyses were not performed
Virological cccDNA response was defined as reduction of intrahepatic cccDNA by 0.5 log in comparison to baseline at the end of follow up.
Outcome measures
Outcome data not reported
Adverse Events
MXB Then PEG IFN
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
MXB + PEG IFN Then PEG IFN
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
PEG IFN
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MXB Then PEG IFN
n=8 participants at risk
Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
|
MXB + PEG IFN Then PEG IFN
n=8 participants at risk
Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by pegINF 180mcg once weekly for 24 weeks
|
PEG IFN
n=8 participants at risk
PEG IFN alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Leucopenia
|
87.5%
7/8 • Number of events 16
|
87.5%
7/8 • Number of events 11
|
87.5%
7/8 • Number of events 17
|
|
Blood and lymphatic system disorders
Neutropenia
|
87.5%
7/8 • Number of events 17
|
87.5%
7/8 • Number of events 15
|
87.5%
7/8 • Number of events 21
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
75.0%
6/8 • Number of events 21
|
62.5%
5/8 • Number of events 14
|
75.0%
6/8 • Number of events 20
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
2/8 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
|
Blood and lymphatic system disorders
Eosinophilia
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Investigations
Alanine aminotransferase increased
|
87.5%
7/8 • Number of events 11
|
37.5%
3/8 • Number of events 4
|
37.5%
3/8 • Number of events 6
|
|
Investigations
Aspartate aminotransferase increased
|
75.0%
6/8 • Number of events 6
|
37.5%
3/8 • Number of events 5
|
37.5%
3/8 • Number of events 4
|
|
Investigations
Gama-glutamyltransferase increased
|
12.5%
1/8 • Number of events 1
|
25.0%
2/8 • Number of events 3
|
25.0%
2/8 • Number of events 5
|
|
Investigations
APTT prolonged
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Investigations
Bilirubin increased
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Investigations
Electrocardiogram QT prolonged
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
General disorders
Influenza like illness
|
62.5%
5/8 • Number of events 5
|
25.0%
2/8 • Number of events 2
|
37.5%
3/8 • Number of events 3
|
|
General disorders
Fatigue
|
25.0%
2/8 • Number of events 2
|
0.00%
0/8
|
50.0%
4/8 • Number of events 4
|
|
General disorders
Pyrexia
|
0.00%
0/8
|
25.0%
2/8 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Dizziness
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Nervous system disorders
Irritability
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place