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A Multicenter, Open-label, Randomized Clinical Study to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination With Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients With Chronic Hepatitis D

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ClinicalTrials.gov Identifier: NCT03546621
Recruitment Status : Completed
First Posted : June 5, 2018
Last Update Posted : June 5, 2018
Sponsor:
Collaborator:
Data Matrix Solutions
Information provided by (Responsible Party):
Hepatera Ltd.

Tracking Information
First Submitted Date  ICMJE May 23, 2018
First Posted Date  ICMJE June 5, 2018
Last Update Posted Date June 5, 2018
Actual Study Start Date  ICMJE February 16, 2016
Actual Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2018)
HDV RNA negativation or decrease by ≥2 log10 from baseline to Week 24 [ Time Frame: 24 weeks ]
HDV RNA negativation or decrease by ≥2 log10 from baseline to Week 24
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2018)
  • Durability of HDV RNA response to 24 weeks post treatment [ Time Frame: 24 weeks ]
  • Combined response: HDV RNA negativation or ≥2 log decline and normal ALT at treatment week 24 [ Time Frame: 24 weeks ]
  • Changes in ALT values at Week 24 and Week 48 compared to baseline [ Time Frame: 24 and 48 weeks ]
  • Lack of fibrosis progression based on transient elastometry (Fibroscan) at Week 24 compared to baseline. [ Time Frame: 24 weeks ]
  • Changes (absence of increase) in fibrosis marker: serum alpha-2-macroglobulin at Week 24 and Week 48 compared to baseline [ Time Frame: 24 and 48 weeks ]
  • Changes in HBsAg (decreased levels, disappearance of HBsAg, antibodies to HBsAg) at Week 24 and Week 48 compared to baseline. [ Time Frame: 24 and 48 weeks ]
  • Change in HBV DNA levels at Week 24 and Week 48 compared to baseline [ Time Frame: 24 and 48 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multicenter, Open-label, Randomized Clinical Study to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination With Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients With Chronic Hepatitis D
Official Title  ICMJE A Multicenter, Open-label, Randomized Clinical Study to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination With Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients With Chronic Hepatitis D
Brief Summary This is a multicenter, open-label, randomized clinical trial to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination with Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients with Chronic Hepatitis D
Detailed Description

This is a multicenter, open-label, randomised, phase II study.

The study will be conducted in Russia and Germany. The study is designed to evaluate the benefit of 3 MXB doses versus observation in patients on background therapy with tenofovir, suffering from hepatitis delta with very limited therapeutic options; the patients will be randomized 1:1:1:1 into 3 treatment arms and an observation arm. Patients with compensated cirrhosis at screening will be stratified to allow similar distribution into each treatment arm. If patients were not receiving treatment with nucleoside/nucelotide analogue, the comparator/background drug will be initiated after the eligibility confirmation, for 12 weeks prior to randomization visit; patients who previously received tenofovir will continue the dosing; patients on different nucleoside/nucleotide analogue will be switched to tenofovir. Observation is considered an adequate control group, as daily placebo injections for 24 weeks are regarded not feasible and ethically questionable.

It is planned to screen 200 patients, and 120 patients will be randomised into four treatment arms in the 1:1:1:1 ratio.

  • Arm A (30 patients): Myrcludex B, 2 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
  • Arm B (30 patients): Myrcludex B, 5 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
  • Arm C (30 patients): Myrcludex B, 10 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
  • Arm D (30 patients): tenofovir treatment for 48 weeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Multicenter, Open-label, Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis D Infection With Hepatitis B
Intervention  ICMJE
  • Drug: Myrcludex B
    2 mg, once daily, subcutaneously
  • Drug: Myrcludex-B
    5 mg, once daily, subcutaneously
  • Drug: Myrcludex-B
    10 mg, once daily, subcutaneously
  • Drug: Tenofovir
    tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
    Other Name: Viread
Study Arms  ICMJE
  • Experimental: Arm A
    Myrcludex B, 2 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
    Interventions:
    • Drug: Myrcludex B
    • Drug: Tenofovir
  • Experimental: Arm B
    Myrcludex B, 5 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
    Interventions:
    • Drug: Myrcludex-B
    • Drug: Tenofovir
  • Experimental: Arm C
    Myrcludex B, 10 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
    Interventions:
    • Drug: Myrcludex-B
    • Drug: Tenofovir
  • Active Comparator: Arm D
    tenofovir treatment for 48 weeks
    Intervention: Drug: Tenofovir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 23, 2018)
120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 31, 2018
Actual Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age from 18 to 65 years inclusively at the time of signing Informed Consent Form.
  2. Positive serum HBsAg for at least 6 months before Screening.
  3. Positive serum anti-HDV antibody for at least 6 months before screening.
  4. Positive PCR results for serum HDV RNA at Screening.
  5. Patients with liver cirrhosis, irrespective of previous interferon treatment .
  6. Patients without liver cirrhosis, who failed prior interferon treatment or for whom, in the opinion of the Investigator, such treatment is currently contraindicated (including history of interferon intolerance) .
  7. Alanine aminotransferase level >1 x ULN, but less than 10 x ULN.
  8. Previous nucleotide/nucleoside analogue treatment within at least 12 weeks prior to the planned start of study treatment or subject's willingness to take tenofovir for at least 12 weeks prior to the planned start of study treatment.
  9. Negative urine pregnancy test for females of childbearing potential.
  10. Inclusion criteria for female subjects:

    • Postmenopausal for at least 2 years, or
    • Surgically sterile (total hysterectomy or bilateral oophorectomy, bilateral tubal ligation, staples, or another type of sterilization), or
    • Abstinence from heterosexual intercourse throughout the study, or
    • Willingness to use highly effective contraception throughout the study and for 3 months after the last dose of the study medication.
  11. Male and female subjects must agree to use a highly effective contraception throughout the study and for 3 months after the last dose of the study medication.
  12. Male subjects must agree not to donate sperm throughout the study and for 3 months after the last dose of the study medication.

Exclusion Criteria:

  1. Child-Pugh score of B-C or over 6 points.
  2. HCV or HIV coinfection. Subjects with anti-HCV antibodies can be enrolled, if screening HCV RNA test is negative.
  3. Creatinine clearance <60 mL/min.
  4. Total bilirubin ≥ 2mg/dL. Patients with higher total bilirubin values may be included after the consultation with the Study`s Medical Monitor, if such elevation can be clearly attributed to Gilbert's syndrome associated with low-grade hyperbilirubinemia.
  5. Any previous or current malignant neoplasms, including hepatic carcinoma.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03546621
Other Study ID Numbers  ICMJE MYR 202
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hepatera Ltd.
Study Sponsor  ICMJE Hepatera Ltd.
Collaborators  ICMJE Data Matrix Solutions
Investigators  ICMJE Not Provided
PRS Account Hepatera Ltd.
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP