We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 306 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

Ledipasvir/Sofosbuvir for Hepatitis B Virus Infection (APOSTLE)

This study is not yet open for participant recruitment.
Verified October 2017 by Joel Chua, University of Maryland
Sponsor:
ClinicalTrials.gov Identifier:
NCT03312023
First Posted: October 17, 2017
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Gilead Sciences
KlinEra Global Services
Information provided by (Responsible Party):
Joel Chua, University of Maryland
  Purpose

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 only a small proportion attain functional cure, which is defined as HBV surface antigen-to-antibody seroconversion. Hepatitis B surface antigen (HBsAg) is a marker of persistent hepatitis B infection.

It has been observed that patients who had both hepatitis B and hepatitis C, and who were treated for their hepatitis C with 12 weeks of ledipasvir/sofosbuvir for had a decline in HBsAg levels. This study hypothesizes that a similar decrease would be seen in mono-infected hepatitis B subjects over the course of 12 weeks treatment with ledipasvir/sofosbuvir.


Condition Intervention Phase
Hepatitis B Drug: Ledipasvir-Sofosbuvir Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Open-label Study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Open-Label Study of Ledipasvir/Sofosbuvir for 12 Weeks in Subjects With Hepatitis B Virus Infection

Resource links provided by NLM:


Further study details as provided by Joel Chua, University of Maryland:

Primary Outcome Measures:
  • Change of serum hepatitis B surface antigen (HBsAg as measured in log10 IU/mL) level as an indicator of antiviral activity of ledipasvir/sofosbuvir in subjects with chronic hepatitis B from baseline to end of 12 weeks treatment. [ Time Frame: 12 weeks ]
    Subjects with chronic hepatitis B will be give 12 weeks of ledipasvir/sofosbuvir and their HBsAg will be measured at baseline, on each visits during therapy, and at end of therapy (week 12). The change in HBsAg from baseline to end of the 12 week treatment will be compared.

  • Incidence of adverse events leading to permanent discontinuation of ledipasvir/sofosbuvir treatment in subjects with chronic hepatitis B infection. [ Time Frame: 12 Weeks ]

Secondary Outcome Measures:
  • Changes in serum hepatitis B virus DNA levels (HBV DNA as measured in IU/mL) with treatment of ledipasvir/sofosbuvir from baseline to end of 12 weeks of treatment in subjects with chronic hepatitis B infection. [ Time Frame: 12 weeks ]
    Subjects with chronic hepatitis B will be give 12 weeks of ledipasvir/sofosbuvir and their serum hepatitis B DNA levels (HBV DNA) will be measured at baseline, on each visits during therapy, and at end of therapy (week 12). The change in HBV DNA levels from baseline to end of the 12 week treatment will be compared.


Estimated Enrollment: 10
Anticipated Study Start Date: December 2017
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LDV/SOF
12 weeks treatment with ledipasvir/sofosbuvir
Drug: Ledipasvir-Sofosbuvir
1 pill once daily for 12 weeks
Other Name: Harvoni

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male or female, aged 18 or older at screening
  4. Diagnosed with chronic hepatitis B infection
  5. HBeAg negative at screening
  6. HBV DNA > lower level of quantitation (LLOQ)
  7. Quantitative HBsAg at least 10 IU/mL at screening
  8. Ability to take oral medication and be willing to adhere to the twelve week study drug regimen
  9. 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 screening and agreement to use such a method during study participation and for an additional 30 days after the end of study drug administration
  10. 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 screening and agreement to use such a method during study participation and for an additional 14 days after the end of study drug administration
  11. Ability to communicate effectively with the study investigator and key staff
  12. Medical management provided by a primary care provider
  13. Ability to store medications at a room temperature of less than 86 degrees Fahrenheit

Exclusion Criteria:

  1. Current use of anticonvulsants, antimycobacterials, St. John's wort, and rosuvastatin
  2. Coinfection with hepatitis C, hepatitis D or human immunodeficiency virus (HIV)
  3. Pregnancy or lactation
  4. Known allergic reactions to components of the Harvoni
  5. Treatment with another investigational drug or other intervention within three months
  6. 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
  7. 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 A1c (HbA1c) greater than 8.5%
  8. 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
  9. Screening electrocardiogram (ECG) with clinically significant findings
  10. Evidence of Hepatocellular carcinoma (e.g., α fetoprotein > 50ng/mL or radiologic evidence)
  11. Clinically significant illicit drug or alcohol abuse within 12 months of screening. Subjects on methadone maintenance treatment or prescribed opioid may be included.
  12. Use of amiodarone within 90 days of screening; or carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifampin, rifapentine, St. John's wort, rosuvastatin within 30 days of screening 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 screening.
  13. Taking antiviral therapy or requiring treatment for HBV during screening
  Contacts and Locations
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): NCT03312023


Contacts
Contact: Joel V Chua, MD 410-706-5704 jchua@ihv.umaryland.edu
Contact: Amy Nelson, BSN, MS 410-706-0100 anelson@ihv.umaryland.edu

Locations
United States, Maryland
Institute of Human Virology (IHV), University of Maryland Baltimore Not yet recruiting
Baltimore, Maryland, United States, 21201
Contact: Joel V Chua, MD    410-706-5704      
Contact: Amy Nelson, BSN, MS    410-706-0100    anelson@ihv.umaryland.edu   
Sponsors and Collaborators
University of Maryland
Gilead Sciences
KlinEra Global Services
Investigators
Principal Investigator: Joel V Chua, MD University of Maryland
  More Information

Responsible Party: Joel Chua, Assistant Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT03312023     History of Changes
Other Study ID Numbers: HP-00074723
First Submitted: September 29, 2017
First Posted: October 17, 2017
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Joel Chua, University of Maryland:
Hepatitis B
HBsAg
Ledipasvir/Sofosbuvir
Hepatitis B treatment

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Virus Diseases
Liver Diseases
Digestive System Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Sofosbuvir
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Antiviral Agents
Anti-Infective Agents