Phase 2
N=90
Myrcludex B in Combination With Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients With Chronic Viral Hepatitis B With Delta-agent
Chronic Viral Hepatitis B With Delta-agent
Bottom Line
View on ClinicalTrials.gov: NCT02888106 ↗Enrolled (actual)
90
Serious AEs
1.1%
Results posted
Feb 2021
Primary outcome: Primary: Percentage of Patients With Negative HDV RNA by PCR — 0; 53.3; 26.7; 6.7 Percentage of participants — p=0.0022
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Myrcludex B (Drug); PEG IFN alfa-2a (Drug); Tenofovir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hepatera Ltd.
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Negative HDV RNA by PCR |
6.7; 60.0; 60.0; 13.3; 66.7; 26.7 | 0.0052 sig |
| SECONDARY Percentage of Patients With Negative HDV RNA by PCR |
6.7; 60.0; 60.0; 13.3; 66.7; 26.7 | 0.0052 sig |
| SECONDARY Percentage of Patients With Normalized ALT |
0; 6.7; 20.0; 64.3; 20.0; 60.0 | 1.0000 |
| SECONDARY Percentage of Patients With Combined Response |
0; 6.7; 20.0; 13.3; 13.3; 13.3 | 1.0000 |
| SECONDARY Percentage of Patients With HВsAg Response |
6.7; 40.0; 13.3; 0; 6.7; 6.7 | 0.0801 |
| SECONDARY Percentage of Patients With HBsAg Negativation |
0; 13.3; 0; 0; 6.7; 0 | 0.4828 |
| SECONDARY Percentage of Patients With Negative HBV DNA by PCR |
33.3; 53.3; 40.0; 33.3; 53.3; 80.0 | 0.4621 |
| SECONDARY The Intensity of Liver Fibrosis Based on Results of Transient Elastometry of Liver at Weeks 48 and 72. |
-0.67; 1.97; -0.27; -0.66; -2.35; -1.12 | — |
| SECONDARY Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment |
0; 0; 1; 4; 3; 8 | — |
| 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). |
-0.062; -0.068; 0.296; -1.220; -1.676; -0.975 | — |
| SECONDARY Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment. |
-0.041; -0.027; -0.132; 0.036; -0.297; 0.087 | — |
| SECONDARY Change in Molecular Analysis of HDAg Positive Hepatocytes (%) From Baseline to Post-treatment |
0.757; 2.178; 1.209; 7.550; 12.521; 3.641 | — |
| SECONDARY Change in the Gene Expression Analyses From Baseline to Post-treatment |
-0.017; -0.012; 0.010; -0.034; 0.003; -0.015 | — |
Summary
Randomised, Comparative, Parallel-Arm Study to Assess Efficacy and Safety of Myrcludex B in Combination with Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients with Chronic Viral Hepatitis B with Delta-agent
Eligibility Criteria
Inclusion Criteria
- Signed Informed Consent form.
- Males and females 18 to 65 years of age (inclusively).
- Patients with chronic hepatitis B (HBeAg-positive or negative) and HBsAg-positive for at least 6 months prior to Screening.
- Positive for anti-HDV antibodies for at least 6 months prior to Screening.
- HDV RNA-positive at Screening.
- ALT ≥ 1 x ULN and 1.5 x ULN.
- Total bilirubin > 34.2 µM/L. Patients with higher total bilirubin may be enrolled upon consultation with the study Medical Monitor, if there is clear evidence that the elevated bilirubin is caused by Gilbert's syndrome.
- Current or previous decompensated liver disease, including coagulopathy, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminaemia, ascites, and oesophageal varices haemorrhage; Child-Pugh score of B/C or ≥6 points.
- HCV or HIV coinfection (patients with anti-HCV antibodies and no HCV RNA at Screening are eligible).
- Hepatocellular carcinoma.
- Signs of drug- or alcohol-induced liver disease or any other medical conditions associated with chronic liver disease (e.g. autoimmune hepatitis, hemochromatosis, thalassaemia, alcoholic hepatitis, toxic liver disease).
- Contraindications for liver biopsy.
- Concurrent malignancy (current diagnosed or suspected malignancy; risk of a previous malignancy recurrence).
- Severe decompensated cardiovascular diseases, including unstable and poorly controlled conditions, over 6 months before Screening.
- History of poorly controlled thyroid conditions or clinically significant signs of thyroid dysfunction at Screening.
- Previous or current severe renal failure or significant renal dysfunction at Screening.
- Previous or current chronic pulmonary disease with respiratory distortion at Screening.
- Previous or current severe retinopathy, significant ophthalmology disorders associated with diabetes mellitus or hypertension.
- Previous or current severe psychiatric disorders at Screening (e.g. severe depressions, suicidal attempts, severe neuroses or cognitive disorders).
- Previous or current endocrine disorders (hypoglycaemia, hyperglycaemia, diabetes mellitus) that are not adequately controlled at Screening.
- History of visceral organ transplantation.
- Signs of drug and/or alcohol dependence (80 g of alcohol/day for men and 40 g of alcohol/day for women) within 1 year before Screening.
- History of immune disorders (e.g. idiopathic thrombocytopenic purpura, lupus erythematosus, sclerodermia, severe psoriasis, rheumatoid arthritis).
- Need for concomitant use of glucocorticoids or myelotoxic agents.
- Participation in another clinical study within 30 days prior to enrollment into this study.
- Pregnant or breast-feeding females.
- Any other condition that, in the opinion of Investigator, precludes the patient from taking part in this study.
Data sourced from ClinicalTrials.gov (NCT02888106). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.