A study to understand the safety and effectiveness of switching to a new drug called Vemlidy from an existing drug called Viread or other oral antiviral treatments drugs for the treatment of long term hepatitis B infection in subjects with renal and/or hepatic impairment

Phase 1

Conditions: Chronic Hepatitis B
MedDRA version: 20.1Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2016-004625-16-IT

Lead Sponsor: GILEAD SCIENCES INCORPORATED

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible to participate in the study:

All Subjects (Parts A and B):
1) Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures
2) Adult male or non-pregnant female subjects, = 18 years of age based on the date of the Screening visit. A negative serum pregnancy test at Screening is required for female subjects of childbearing potential
3) Documented evidence of chronic HBV infection (e.g. HBsAg positive for = 6 months)
4) Normal ECG (or if abnormal, determined by the Investigator not to be clinically significant)
5) ALT = 10 × upper limit of normal (ULN) at Screening by central laboratory
6) Must be willing and able to comply with all study requirements

Part A Only (renal impairment):
1) Maintained on TDF and/or other OAV treatment(s) for CHB for at least 48 weeks and with viral suppression (HBV DNA < LLOQ) for = 6 months prior to Screening
2) Moderate renal impairment (30 mL/min = eGFRCG = 59 mL/min), severe renal impairment (15 mL/min = eGFRCG < 30 mL/min) using the Cockcroft-Gault equation, or ESRD (eGFR < 15 mL/min) maintained on HD

Part B Only (hepatic impairment):
1) Maintained on TDF and/or other OAV(s) for CHB for at least 48 weeks and with viral suppression (HBV DNA < LLOQ) for = 6 months prior to Screening
2) CPT score (Appendix 7) of 7-12 (inclusive) OR a past history of CPT score = 7 and any CPT score = 12 at Screening
3) eGFRCG = 30 mL/min using the Cockcroft-Gault equation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 84
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

All Subjects (Parts A & B):
1) Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study
2) Males and females of reproductive potential who are unwilling to use an effective”, protocol-specified method(s) of contraception during the study
3) Co-infection with HCV, HIV, or HDV
-Subjects who are HCV positive, but have a documented negative HCV RNA, are eligible
4) Prior Interferon (IFN) use within 6 months of Screening
5) Evidence of hepatocellular carcinoma (i.e. evidenced by imaging within 6 months of Screening)
6) Received solid organ or bone marrow transplant
7) Significant cardiovascular, pulmonary, or neurological disease in the opinion of the investigator
8) Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc.). Subjects under evaluation for possible malignancy are not eligible
9) Currently receiving therapy with immunomodulators (e.g. corticosteroids), nephrotoxic agents, or agents capable of modifying renal excretion
10) Known hypersensitivity to study drugs, metabolites, or formulation excipients
11) Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance
12) Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements.
13) Use of investigational agents within 3 months of Screening, unless allowed by the Sponsor
14) Use of any prohibited medication

Part A Only (renal impairment):
1) Current or historical evidence of clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage)
2) Abnormal hematological and biochemical parameters
3) Subjects with ESRD (i.e. eGFRCG < 15 mL/min) not on HD, or those on other forms of renal replacement therapy (i.e. peritoneal dialysis)

Part B Only (hepatic impairment):
1) Active variceal bleeding within 6 months or prior placement of a portosystemic shunt (such as transjugular intrahepatic portosystemic shunt [TIPS])
2) History of hepatorenal syndrome, hepatopulmonary syndrome, Grade 3 or Grade 4 hepatic encephalopathy, or spontaneous bacterial peritonitis within 6 months of Screening
3) Grade 2 hepatic encephalopathy at Screening
4) MELD score = 30
5) Abnormal hematological and biochemical parameters

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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