Overview

This trial is active, not recruiting.

Condition chronic viral hepatitis b with delta-agent
Treatments myrcludex b, peg ifn alfa-2a
Phase phase 2
Sponsor Hepatera Ltd.
Start date April 2016
End date December 2018
Trial size 60 participants
Trial identifier NCT02888106, MYR203

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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
PEG IFN alfa-2a 180 µg for 48 weeks
peg ifn alfa-2a
(Experimental)
Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks
myrcludex b
peg ifn alfa-2a
(Experimental)
Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks
myrcludex b
peg ifn alfa-2a
(Experimental)
Myrcludex B 2 mg for 48 weeks
myrcludex b

Primary Outcomes

Measure
Proportion of patients with negative HDV RNA by PCR
time frame: 72 weeks

Secondary Outcomes

Measure
Proportion of patients with negative HDV RNA by PCR
time frame: 24 and 48 weeks
Proportion of patients with normalized ALT
time frame: 24, 48 and 72 weeks
Proportion of patients with combined response
time frame: 24, 48 and 72 weeks
Proportion of patients with HВsAg response
time frame: 24, 48 and 72 weeks
Proportion of patients with undetectable HВsAg with or without anti-HBsAg antibodies
time frame: 24, 48 and 72 weeks
Proportion of patients with negative HBV DNA by PCR
time frame: 24, 48 and 72 weeks
The severity of fibrosis evaluated by transient elastometry of the liver
time frame: 48 and 72 weeks

Eligibility Criteria

Male or female participants of any age.

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 < 10 x ULN.
  • The patient agree to use adequate method of contraception during the study, starting from the time of Informed Consent signing and until completion of Follow-up Period.

Exclusion Criteria

  • Intolerance or hypersensitivity to the active ingredient or other components of the study drug Myrcludex B.
  • Intolerance or hypersensitivity to interferons alfa, genetically engineered E.coli medications, polyethylene glycol or other components of peginterferon alfa-2a.
  • Previous treatment with Myrcludex B (patients with previous exposure to interferon are eligible).
  • Therapy with antiviral drugs for chronic viral hepatitis B with delta-agent over the previous 6 months.
  • Therapy with anti-tumour agents (including radiotherapy) or immunomodulatory medications (including systemic glucocorticoids) over the previous 6 months.
  • The following laboratory test results at Screening:
    • Hemoglobin < 100 g/L
    • Leucocytes < 3000/µL
    • Neutrophils < 1500/µL
    • Platelets < 90000/µL
    • Serum creatinine >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.

Additional Information

Official title A Multicenter, Open-label, Randomised, Comparative, Parallel-Arm, Phase II 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
Description This is a multicenter, open-label, randomised, comparative, active-controlled parallel-arm phase II study. The study will be conducted in Russia. The aim of this study is to investigate efficacy and safety of Myrcludex B alone and in combination with peginterferon alfa-2a compared to peginterferon alfa-2a alone in patients with chronic viral hepatitis B with delta-agent. The study is also aimed at investigating immunogenicity of Myrcludex B and the drug pharmacokinetics when used in combination with PEG IFN alfa-2a. It is planned to screen 100 patients, and 60 patients will be randomised into four treatment arms in the 1:1:1:1 ratio. - Arm A (n=15): PEG IFN alfa-2a 180 µg for 48 weeks - Arm B (n=15): Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks - Arm C (n=15): Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks - Arm D (n=15): Myrcludex B 2 mg for 48 weeks
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Hepatera Ltd..