Clinical trial NCT01671787: A Phase 1b Study Assessing GS-7340 in Treatment-Naive Adults With Chronic Hepatitis B
Official title: A Phase 1b Randomized, Open Label, Active-Controlled Study to Assess the Safety, Viral Kinetics, and Anti-HBV Activity of GS-7340 in Treatment-Naive Adults With Chronic Hepatitis B (CHB) Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis B
Keywords: Hepatitis B
HBV
GS-7340
TDF
Tenofovir disoproxil fumarate
Gilead
Viread
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2012-08-24
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-label study evaluating multiple doses of GS-7340 versus Tenofovir disoproxil fumarate (TDF).

Detailed description: This is a randomized, open-label, active-controlled study whose primary objective is to evaluate the safety and efficacy of several doses of GS-7340. This study will evaluate the safety, viral kinetics, and antiviral activity of 4 different doses of GS-7340 over 28 days of therapy. In addition, the study will evaluate the antiviral activity of an optimal dose of GS-7340 versus 300mg Tenofovir disoproxil fumarate (TDF) over 28 days of therapy.

Eligibility criteria: Inclusion Criteria:

* Must be between 18 and 65 years of age
* Must have Screening plasma HBV DNA ≥ 2x10\^3 IU/mL
* Must have chronic HBV infection for at least 6 months
* Must have estimated creatinine clearance (CLCr) ≥ 70 mL/min
* Not pregnant or nursing
* Women must be of non-childbearing potential OR of childbearing potential with confirmed negative pregnancy tests
* Consistent and correct use of recommended methods of birth control for men and women

Exclusion Criteria:

* Pregnant or lactating subjects
* Receipt of anti-HBV nucleoside/nucleotide therapy. Subjects who have failed prior Interferon treatment, greater than 6 months prior to screening, are permitted to participate in the study screening
* Known co-infection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV)
* Presence of autoimmune disorders
* History of liver disease other than Hepatitis B
* History of Gilbert's Disease
* Any sign of decompensated liver disease
* Known or suspected cirrhosis
* Evidence of hepatocellular carcinoma
* Presence or history of cardiovascular disease, cardiomyopathy, and/or cardiac conduction abnormalities
* Electrolyte abnormalities
* History of treatment that permanently alters the gastric condition
* Alcohol or substance abuse
* History of bleeding diathesis
* Significant bone disease

Primary outcomes:
measure: Change in serum hepatitis B virus (HBV) DNA
timeFrame: Up to Week 4
Secondary outcomes:
measure: Change in HBV DNA for tenofovir disoproxil fumarate (TDF)
timeFrame: Up to Week 4
measure: Change in HBV DNA of GS-7340 through 28 days of therapy
timeFrame: Up to week 4
measure: Pharmacokinetics (PK) of GS-7340 and/or tenofovir (TVF) following single and multiple doses of GS-7340 and TDF
timeFrame: Up to week 4
measure: Safety and Tolerability of Therapy
timeFrame: Up to week 4
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Research and Education Inc.
state: California
city: Baltimore
country: United States
facility: University of Maryland Institute of Human Virology
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Houston
country: United States
facility: Baylor College of Medicine - St. Luke's Episcopal Hospital
state: Texas
city: Melborne
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Austin Health
state: Victoria
city: Nedlands
country: Australia
facility: Linear Clinical Research Ltd
state: Western Australia
city: Vancouver
country: Canada
facility: Downtown Infectious Diseases Clinic (University of British Columbia)
state: British Columbia
city: Ottawa
country: Canada
facility: The Ottawa Hospital, General Campus
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Algorithme Pharma
state: Quebec
city: St. Romuald
country: Canada
facility: Pro-recherche
state: Quebec
city: Auckland
country: New Zealand
facility: Auckland Clinical Studies
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: London
country: United Kingdom
facility: Grahame Hayton Unit
city: London
country: United Kingdom
facility: University College London Hospital
city: London
country: United Kingdom
facility: Institute of Liver Studies, King's College Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust - Queens Medical Centre
Study officials:
affiliation: Gilead Sciences
name: John Flaherty, MD
role: STUDY_DIRECTOR
References: