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Trial record 3 of 4 for:    Myrcludex | hepatitis D

Study to Assess Efficacy and Safety of Bulevirtide in Participants With Chronic Hepatitis Delta (CHD)

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ClinicalTrials.gov Identifier: NCT03852719
Recruitment Status : Active, not recruiting
First Posted : February 25, 2019
Last Update Posted : November 17, 2021
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objective of this study is to evaluate the efficacy of bulevirtide for treatment of CHD in comparison to delayed treatment.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis Delta Drug: Bulevirtide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Randomized Phase 3 Clinical Study to Assess Efficacy and Safety of Bulevirtide in Patients With Chronic Hepatitis Delta
Actual Study Start Date : April 17, 2019
Actual Primary Completion Date : November 26, 2020
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Delayed Treatment
Participants will receive delayed treatment with bulevirtide 10 mg/day subcutaneously (SC) for 96 weeks after an observational period of 48 weeks.
Drug: Bulevirtide
Administered via SC injections
Other Names:
  • Myrcludex B
  • Hepcludex®

Experimental: Bulevirtide 2 mg/day
Participants will receive bulevirtide 2 mg/day SC for 144 weeks.
Drug: Bulevirtide
Administered via SC injections
Other Names:
  • Myrcludex B
  • Hepcludex®

Experimental: Bulevirtide 10 mg/day
Participants will receive bulevirtide 10 mg/day SC for 144 weeks.
Drug: Bulevirtide
Administered via SC injections
Other Names:
  • Myrcludex B
  • Hepcludex®




Primary Outcome Measures :
  1. Combined Response at Week 48: Percentage of Participants with Undetectable (< LoD) Hepatitis Delta Virus Ribonucleic Acid (HDV RNA) or Decrease by ≥ 2 log10 IU/ml From Baseline and ALT Normalization [ Time Frame: Week 48 ]

Secondary Outcome Measures :
  1. Percentage of Participants with Undetectable HDV RNA at Week 48 [ Time Frame: Week 48 ]
  2. Percentage of Participants with ALT Normalization at Week 48 [ Time Frame: Week 48 ]
  3. Percentage of Participants with Undetectable HDV RNA 24 Weeks after Scheduled End of Treatment (Sustained Virological Response) [ Time Frame: Posttreatment Week 24 ]
  4. Percentage of Participants with Undetectable HDV RNA 48 Weeks after Scheduled End of Treatment (Sustained Virological Response) [ Time Frame: Posttreatment Week 48 ]
  5. Change from Baseline in Liver Stiffness as Measured by Elastography at Week 48 [ Time Frame: Baseline, Week 48 ]
  6. Change from Baseline in Liver Stiffness as Measured by Elastography at Week 96 [ Time Frame: Baseline, Week 96 ]
  7. Change from Baseline in Liver Stiffness as Measured by Elastography at Week 144 [ Time Frame: Baseline, Week 144 ]
  8. Change from Baseline in Liver Stiffness as Measured by Elastography at Week 192 [ Time Frame: Baseline, Week 192 ]
  9. Change from Baseline in Liver Stiffness as Measured by Elastography at Weeks 240 [ Time Frame: Baseline, Week 240 ]
  10. Percentage of Participants who Permanently Discontinue Study Drug due to an Adverse Event [ Time Frame: Up to 144 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of signed and dated informed consent form.
  2. Positive serum anti-hepatitis delta virus (HDV) antibody results or polymerase chain reaction (PCR) results for serum/ plasma HDV ribonucleic acid (RNA) for at least 6 months before screening.
  3. Positive PCR results for serum/plasma HDV RNA at screening.
  4. Alanine transaminase level > 1 x upper limit of normal (ULN), but less than 10 x ULN.
  5. Serum albumin > 28 g/L.
  6. Negative urine pregnancy test for females of childbearing potential.
  7. Inclusion criteria for females:

    • 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 (double barrier method or barrier contraception in combination with hormonal or intrauterine contraceptive) throughout the study and for 3 months after the last dose of the study medication for participants discontinued during the treatment period.
  8. Individuals must agree to use a highly effective contraception (double barrier method or barrier contraception in combination with hormonal or intrauterine contraceptive used by female partners) and not to donate sperm throughout the study and for 3 months after the last dose of the study medication for participants discontinued during the treatment period.

Exclusion Criteria:

  1. Child-Pugh hepatic insufficiency score over 7 points. Uncomplicated oesophageal varices allowed; Individuals with current bleeding or ligation, or history of bleeding or ligation within the last 2 years are excluded.
  2. Hepatitis C virus (HCV) or uncontrolled human immunodeficiency virus (HIV) coinfection. Individuals with HCV antibodies can be enrolled, if screening HCV RNA test is negative. Individuals with HIV infection can be enrolled if cluster of differentiation (CD4+) cell counts are >500/mL and HIV RNA is below limit of detection for at least 12 months.
  3. Creatinine clearance < 60 mL/min as estimated using Cockcroft-Gault formula.
  4. Total bilirubin ≥ 34.2 µmol/L. (Participants with higher total bilirubin values may be included after the consultation with the Study Medical Monitor, if such elevation can be clearly attributed to Gilbert's syndrome associated with low-grade hyperbilirubinemia.)
  5. Evidence of an active or suspected malignancy or a history of malignancy, or an untreated pre-malignancy disorder within the last 5 years (with the exception of successfully treated carcinoma of the cervix in situ and successfully treated basal cell carcinoma and squamous cell carcinoma not less than 1 year prior to screening [and no more than 3 excised skin cancer within the last 5 years prior to screening]) or history of hepatic carcinoma.
  6. Systemic connective tissue disorders.
  7. New York Heart Association (NYHA) class III-IV congestive heart failure.
  8. Participants with uncontrolled arterial hypertension: systolic blood pressure > 150 mm Hg and/ or diastolic blood pressure > 100 mm Hg at Screening.
  9. Previous or unstable concurrent diseases or conditions that prevent individual's enrolment into the study.
  10. Participants with mental disorders or social circumstances that preclude them from following protocol requirements.
  11. Current or previous (within last 2 years) decompensated liver disease, including coagulopathy, hepatic encephalopathy and esophageal varices hemorrhage.
  12. One or more additional known primary or secondary causes of liver disease, other than hepatitis B (e.g., alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson's Disease, other congenital or metabolic conditions affecting the liver, congestive heart failure or other severe cardiopulmonary disease, etc.). Gilbert's syndrome, a benign disorder associated with low-grade hyperbilirubinemia, will not exclude patients from participation in this trial. Autoimmune hepatitis stigmata attributed to HDV infection in the opinion of the investigator are allowed.
  13. White blood cells (WBC) count < 3000 cells/mm^3 (<1500 if African participants).
  14. Neutrophil count < 1500 cells/mm^3 (<1000 if African participants).
  15. Platelet count < 60,000 cells/mm^3.
  16. Use of prohibited psychotropic agents at Screening.
  17. Use of interferons within 6 months before Screening.
  18. History of solid organ transplantation.
  19. Current alcohol abuse or alcohol abuse within 6 months prior to enrolment in this study; past or current drug addict.
  20. History of disease requiring regular use of systemic glucocorticosteroids (inhalative glucocorticosteroids are allowed) or other immunosuppressants.
  21. Pregnant or breast-feeding females.
  22. Participation in another clinical study with investigational drugs within 30 days prior to randomization.
  23. Receipt of bulevirtide previously, e.g. in clinical trials.
  24. Inability to follow protocol requirements and undergo all protocol procedures. NOTE: Participants with medical contraindication for liver biopsy are allowed to participate in this study. Such participants will exempt from liver biopsy requirements in this study.

Individuals receiving prohibited treatment at Screening cannot be included into the study unless this treatment is withdrawn prior to randomization.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03852719


Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03852719    
Other Study ID Numbers: MYR 301
2019-001213-17 ( EudraCT Number )
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: November 17, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis D
Hepatitis
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections