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Trial record 66 of 1269 for:    IFNA2

Myrcludex B Plus Pegylated Interferon-alpha-2a in Patients With HBeAg Negative HBV/HDV Co-infection

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ClinicalTrials.gov Identifier: NCT02637999
Recruitment Status : Completed
First Posted : December 22, 2015
Results First Posted : April 13, 2018
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Hepatera Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Hepatitis D Infection
Interventions Drug: PEG IFN alfa-2a
Drug: Myrcludex B
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MXB Then PEG IFN MXB + PEG IFN Then PEG IFN PEG IFN
Hide Arm/Group Description Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks 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 alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
Period Title: Overall Study
Started 8 8 8
Completed 7 6 6
Not Completed 1 2 2
Arm/Group Title MXB Then PEG IFN MXB + PEG IFN Then PEG IFN PEG IFN Total
Hide Arm/Group Description Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks 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 alfa-2a 180 µg/0.5 mL once weekly for 48 weeks Total of all reporting groups
Overall Number of Baseline Participants 8 8 8 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
8
 100.0%
8
 100.0%
24
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 8 participants 24 participants
38.3  (10.05) 33.0  (4.87) 42.1  (10.23) 37.8  (9.19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 24 participants
Female
3
  37.5%
1
  12.5%
2
  25.0%
6
  25.0%
Male
5
  62.5%
7
  87.5%
6
  75.0%
18
  75.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 24 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
8
 100.0%
8
 100.0%
8
 100.0%
24
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Russia Number Analyzed 8 participants 8 participants 8 participants 24 participants
8 8 8 24
1.Primary Outcome
Title Number of Participants With Hepatitis B Surface Antigen (HBsAg) Response at Week 12 of Therapy
Hide Description 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)
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.
Arm/Group Title MXB Then PEG IFN MXB + PEG IFN Then PEG IFN PEG IFN
Hide Arm/Group Description:
Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
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 alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
Overall Number of Participants Analyzed 8 8 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Number of Participants With Hepatitis B Surface Antigen (HBsAg) Response at Week 24 of Therapy
Hide Description 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)
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.
Arm/Group Title MXB Then PEG IFN MXB + PEG IFN Then PEG IFN PEG IFN
Hide Arm/Group Description:
Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
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 alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
Overall Number of Participants Analyzed 8 8 8
Measure Type: Count of Participants
Unit of Measure: Participants
2
  25.0%
1
  12.5%
3
  37.5%
3.Secondary Outcome
Title Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Response at Week 24 of Therapy
Hide Description 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)
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MXB Then PEG IFN MXB + PEG IFN Then PEG IFN PEG IFN
Hide Arm/Group Description:
Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
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 alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
Overall Number of Participants Analyzed 8 8 8
Measure Type: Count of Participants
Unit of Measure: Participants
2
  25.0%
6
  75.0%
3
  37.5%
4.Secondary Outcome
Title Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Response at Week 12 of Therapy
Hide Description 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)
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.
Arm/Group Title MXB Then PEG IFN MXB + PEG IFN Then PEG IFN PEG IFN
Hide Arm/Group Description:
Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
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 alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
Overall Number of Participants Analyzed 8 8 8
Measure Type: Count of Participants
Unit of Measure: Participants
1
  12.5%
5
  62.5%
1
  12.5%
5.Secondary Outcome
Title Number of Participants With Hepatitis D Virus Ribonucleic Acid (HDV RNA) Response at Week 12 of Therapy
Hide Description 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)
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.
Arm/Group Title MXB Then PEG IFN MXB + PEG IFN Then PEG IFN PEG IFN
Hide Arm/Group Description:
Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
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 alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
Overall Number of Participants Analyzed 8 8 8
Measure Type: Count of Participants
Unit of Measure: Participants
4
  50.0%
5
  62.5%
6
  75.0%
6.Secondary Outcome
Title Number of Participants With Hepatitis D Virus Ribonucleic Acid (HDV RNA) Response at Week 24 of Therapy
Hide Description 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)
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.
Arm/Group Title MXB Then PEG IFN MXB + PEG IFN Then PEG IFN PEG IFN
Hide Arm/Group Description:
Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
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 alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
Overall Number of Participants Analyzed 8 8 8
Measure Type: Count of Participants
Unit of Measure: Participants
7
  87.5%
7
  87.5%
7
  87.5%
7.Secondary Outcome
Title Number of Participants With Biochemical Response at Week 12 of Therapy
Hide Description Biochemical response was defined as normalization of ALT level as compared to baseline.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.
Arm/Group Title MXB Then PEG IFN MXB + PEG IFN Then PEG IFN PEG IFN
Hide Arm/Group Description:
Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
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 alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
Overall Number of Participants Analyzed 8 8 8
Measure Type: Count of Participants
Unit of Measure: Participants
2
  25.0%
2
  25.0%
2
  25.0%
8.Secondary Outcome
Title Number of Participants With Biochemical Response at Week 24 of Therapy
Hide Description Biochemical response was defined as normalization of ALT level as compared to baseline.
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.
Arm/Group Title MXB Then PEG IFN MXB + PEG IFN Then PEG IFN PEG IFN
Hide Arm/Group Description:
Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
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 alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
Overall Number of Participants Analyzed 8 8 8
Measure Type: Count of Participants
Unit of Measure: Participants
6
  75.0%
1
  12.5%
1
  12.5%
9.Secondary Outcome
Title Number of Participants With Covalently Closed Circular Deoxyribonucleic Acid (cccDNA) Response at Week 72 of Therapy
Hide Description Virological cccDNA response was defined as reduction of intrahepatic cccDNA by 0.5 log in comparison to baseline at the end of follow up.
Time Frame Baseline and 72 weeks for arm A and 48 weeks for arms B and C
Hide Outcome Measure Data
Hide Analysis Population Description
No data to be reported due to absence of biopsy data. Biopsy data are unavailable because analyses were not performed
Arm/Group Title MXB Then PEG IFN MXB + PEG IFN Then PEG IFN PEG IFN
Hide Arm/Group Description:
Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
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 alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MXB Then PEG IFN MXB + PEG IFN Then PEG IFN PEG IFN
Hide Arm/Group Description Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks 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 alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
All-Cause Mortality
MXB Then PEG IFN MXB + PEG IFN Then PEG IFN PEG IFN
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MXB Then PEG IFN MXB + PEG IFN Then PEG IFN PEG IFN
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/8 (0.00%)      0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MXB Then PEG IFN MXB + PEG IFN Then PEG IFN PEG IFN
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/8 (100.00%)      8/8 (100.00%)      8/8 (100.00%)    
Blood and lymphatic system disorders       
Leucopenia  1  7/8 (87.50%)  16 7/8 (87.50%)  11 7/8 (87.50%)  17
Neutropenia  1  7/8 (87.50%)  17 7/8 (87.50%)  15 7/8 (87.50%)  21
Thrombocytopenia  1  6/8 (75.00%)  21 5/8 (62.50%)  14 6/8 (75.00%)  20
Anaemia  1  2/8 (25.00%)  2 0/8 (0.00%)  0 0/8 (0.00%)  0
Eosinophilia  1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
General disorders       
Influenza like illness  1  5/8 (62.50%)  5 2/8 (25.00%)  2 3/8 (37.50%)  3
Fatigue  1  2/8 (25.00%)  2 0/8 (0.00%)  0 4/8 (50.00%)  4
Pyrexia  1  0/8 (0.00%)  0 2/8 (25.00%)  2 1/8 (12.50%)  1
Dizziness  1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Investigations       
Alanine aminotransferase increased  1  7/8 (87.50%)  11 3/8 (37.50%)  4 3/8 (37.50%)  6
Aspartate aminotransferase increased  1  6/8 (75.00%)  6 3/8 (37.50%)  5 3/8 (37.50%)  4
Gama-glutamyltransferase increased  1  1/8 (12.50%)  1 2/8 (25.00%)  3 2/8 (25.00%)  5
APTT prolonged  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Bilirubin increased  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Electrocardiogram QT prolonged  1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Nervous system disorders       
Irritability  1  1/8 (12.50%)  1 0/8 (0.00%)  0 1/8 (12.50%)  1
Skin and subcutaneous tissue disorders       
Rash  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. med. Alexander Alexandrov
Organization: MYR GmbH
Phone: +491777168259
Publications:
Responsible Party: Hepatera Ltd.
ClinicalTrials.gov Identifier: NCT02637999     History of Changes
Other Study ID Numbers: MYR 201 (HDV)
First Submitted: December 17, 2015
First Posted: December 22, 2015
Results First Submitted: December 28, 2017
Results First Posted: April 13, 2018
Last Update Posted: April 13, 2018