Status:
COMPLETED
Ledipasvir/Sofosbuvir for Hepatitis B Virus Infection
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
Gilead Sciences
Conditions:
Hepatitis B
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goals of therapy against chronic hepatitis B are to decrease the morbidity and mortality related to chronic HBV infection. Currently available antiviral therapy can suppress viral replication but ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Participants in Groups A, C \& D (Chronic HBV, low replicative state not requiring treatment):
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 or older at screening
- Diagnosed with chronic hepatitis B infection defined as one of the following:
- HBsAg or HBV DNA positivity for at least 6 months
- Medical records indicating a chronic HBV infection
- HBeAg negative at screening
- HBV DNA \> lower level of quantitation (LLOQ)
- Quantitative HBsAg at least 10 IU/mL at screening
- Ability to take oral medication and be willing to adhere to the twelve week study drug regimen
- For females of reproductive potential: usual practice of complete abstinence from sexual intercourse with a member of the opposite sex OR use of at least one form of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation and for an additional 30 days after the end of study drug administration
- For males of reproductive potential: usual practice of complete abstinence from sexual intercourse with a member of the opposite sex OR use of at least one form of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation and for an additional 14 days after the end of study drug administration
- Ability to communicate effectively with the study investigator and key staff
- Medical management provided by a primary care provider
- Ability to store medications at a room temperature of less than 86 degrees Fahrenheit
- Not on antiviral therapy or requiring treatment for HBV during screening
- Participants in Group B (Chronic HBV, virally suppressed):
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 or older at screening
- Diagnosed with chronic hepatitis B infection defined as one of the following:
- HBsAg or HBV DNA positivity for at least 6 months
- Medical records indicating a chronic HBV infection
- Receiving oral anti-HBV medications (either tenofovir alafenamide, tenofovir disoproxil fumarate, entecavir, or a combination of no more than 2 of these agents) for at least three months prior to enrollment
- HBV DNA ˂ lower level of quantitation (LLOQ) at screening and for at least three months prior
- Quantitative HBsAg at least 10 IU/mL at screening
- Ability to take oral medication and be willing to adhere to the twelve week study drug regimen
- For females of reproductive potential: usual practice of complete abstinence from sexual intercourse with a member of the opposite sex OR use of at least one form of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation and for an additional 30 days after the end of study drug administration
- For males of reproductive potential: usual practice of complete abstinence from sexual intercourse with a member of the opposite sex OR use of at least one form of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation and for an additional 14 days after the end of study drug administration
- Ability to communicate effectively with the study investigator and key staff
- Medical management provided by a primary care provider
- Ability to store medications at a room temperature of less than 86 degrees Fahrenheit
- EXCLUSION CRITERIA
- Coinfection with hepatitis C, hepatitis D or human immunodeficiency virus (HIV)
- Pregnancy or lactation
- Known allergic reactions to sofosbuvir or ledipasvir
- Treatment with another investigational drug or other intervention within three months
- Evidence of cirrhosis or hepatic decompensation such as:
- Platelets less than 100,000 /mm3
- Albumin less than 3.5 g/dL
- INR greater than 1.7 or Prothrombin time of 1.5 times the upper limit of normal (ULN)
- Total bilirubin of 1.5 times the upper limit of normal
- FibroTest (or FibroSure®) of 0.75 or greater
- Abnormal hematological and biochemical parameters at screening including:
- White blood cell count less than 2500 cells/uL
- Absolute neutrophil count (ANC) less than 1,000 cells/mm3 (less than 750 mm3 for African or African-American subjects)
- Hemoglobin less than 12 g/dL for males, less than 11 g/dL for females
- AST or ALT of two times the upper limit of normal
- Estimated GFR less than 50 mL/min
- Glycosylated hemoglobin (HbA1c) greater than 8.5%
- Current or prior history of any of the following:
- Immunodeficiency disorders or autoimmune disease (e.g. Systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel diseases, sarcoidosis, psoriasis of greater than mild severity)
- Severe pulmonary disorders, significant cardiac diseases
- Gastrointestinal disorder with post-operative condition that could interfere with the absorption of the study drugs
- Significant psychiatric illness that in the judgment of the Investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
- Any malignancy diagnosed within 5 years (not including recent localized treatment of squamous or non-invasive basal cell skin cancer; cervical carcinoma in situ appropriately treated prior to screening)
- Solid organ transplantation
- Poor venous access
- Screening ECG with clinically significant findings
- Evidence of HCC (e.g., α fetoprotein \> 50ng/mL or radiologic evidence)
- Clinically significant illicit drug or alcohol abuse within 12 months of screening. Subjects on methadone maintenance treatment or prescribed opioid may be included.
- Use of amiodarone within 90 days of enrollment; or carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifampin, rifapentine, St. John's wort, rosuvastatin, or interferon within 30 days of enrollment or expected use of these prohibited drugs during study participation. Use of or expected need of proton-pump inhibitors more than 20 mg omeprazole equivalent or H2 receptor antagonist more than 40 mg famotidine BID equivalent within 7 days of enrollment.
Exclusion
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03312023
Start Date
February 1 2018
End Date
June 30 2021
Last Update
September 20 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institute of Human Virology (IHV), University of Maryland Baltimore
Baltimore, Maryland, United States, 21201