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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02637999
Other study ID # MYR 201 (HDV)
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received December 17, 2015
Last updated April 10, 2018
Start date February 13, 2014
Est. completion date January 21, 2016

Study information

Verified date April 2018
Source Hepatera Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Randomized open-label substudy of daily Myrcludex B (MXB) plus pegylated interferon-alpha-2a (PEG-INF-a) in patients with hepatitis B e antigen (HBeAg) negative chronic hepatitis B virus (HBV) co-infected with hepatitis delta virus (HDV).


Description:

The study is designed to evaluate safety and efficacy of MXB in a subset of HBV infected patients who are co-infected with HDV. Hepatitis delta represents the most severe form of chronic viral hepatitis and there is no approved treatment option available for patients infected with both HBV and HDV.

24 patients will be randomised into 3 arms: pre-treatment with MXB followed by PEG-INF-a treatment versus a combination of both drugs versus PEG-INF-a.

Prolonged blockade of HBV entry into hepatocytes should also block infection with HDV particles (which uses hepatitis B surface antigen (HBsAg) as its envelope) and thus provide a therapeutic option for this otherwise hardly treatable disease. PEG-INF-a is used for the treatment of chronic hepatitis delta. The study endpoints are virological response (HBsAg, hepatitis delta virus ribonucleic acid (HDV RNA), hepatitis B virus deoxyribonucleic acid (HBV DNA)), as well as safety and tolerability and drug immunogenicity.


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Study Design


Intervention

Drug:
PEG IFN alfa-2a

Myrcludex B


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hepatera Ltd.

References & Publications (6)

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Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Hepatitis B Surface Antigen (HBsAg) Response at Week 12 of Therapy 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) Baseline and 12 weeks
Secondary Number of Participants With Hepatitis B Surface Antigen (HBsAg) Response at Week 24 of Therapy 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) Baseline and 24 weeks
Secondary Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Response at Week 24 of Therapy 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) Baseline and 24 weeks
Secondary Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Response at Week 12 of Therapy 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) Baseline and 12 weeks
Secondary Number of Participants With Hepatitis D Virus Ribonucleic Acid (HDV RNA) Response at Week 12 of Therapy 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) Baseline and 12 weeks
Secondary Number of Participants With Hepatitis D Virus Ribonucleic Acid (HDV RNA) Response at Week 24 of Therapy 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) Baseline and 24 weeks
Secondary Number of Participants With Biochemical Response at Week 12 of Therapy Biochemical response was defined as normalization of ALT level as compared to baseline. Baseline and 12 weeks
Secondary Number of Participants With Biochemical Response at Week 24 of Therapy Biochemical response was defined as normalization of ALT level as compared to baseline. Baseline and 24 weeks
Secondary Number of Participants With Covalently Closed Circular Deoxyribonucleic Acid (cccDNA) Response at Week 72 of Therapy Virological cccDNA response was defined as reduction of intrahepatic cccDNA by 0.5 log in comparison to baseline at the end of follow up. Baseline and 72 weeks for arm A and 48 weeks for arms B and C
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