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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01590641




Registration number
NCT01590641
Ethics application status
Date submitted
30/04/2012
Date registered
3/05/2012
Date last updated
14/11/2013

Titles & IDs
Public title
A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B
Scientific title
A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple- Dose Ranging, Adaptive Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Activity of GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B Virus Infection
Secondary ID [1] 0 0
GS-US-283-0106
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B 0 0
HBV 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Single Ascending Dose (SAD) Cohorts GS-9620
Treatment: Drugs - Multiple Ascending Dose (MAD) Cohorts

Experimental: 0.3mg GS-9620 -

Experimental: 1mg GS-9620 -

Experimental: 2mg GS-9620 -

Experimental: 4mg GS-9620 -

Experimental: 0.3mg GS-9620 QW x 2 doses -

Experimental: 1mg GS-9620 QW x 2 doses -

Experimental: 2mg GS-9620 QW x 2 doses -

Experimental: 4mg GS-9620 QW x 2 doses -


Treatment: Drugs: Single Ascending Dose (SAD) Cohorts GS-9620
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.

Treatment: Drugs: Multiple Ascending Dose (MAD) Cohorts
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assessment of adverse events in single and multiple oral doses of GS-9620 - Safety will be assessed during the study through the reporting of adverse events, by clinical laboratory tests, physical examinations including vital signs and ECGs at various time points during the study, and by documentation of concomitant medications throughout the study.
Timepoint [1] 0 0
Periodically Through Week 25
Secondary outcome [1] 0 0
Assessment of plasma drug concentrations of GS-9620 using non-compartmental methods - Single ascending dose (SAD) and multiple ascending dose (MAD) Cohorts:serial blood samples will be collected on Day 1 at 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48, and 96 hours post-dose.
MAD Cohorts: serial blood samples will also be collected on Day 8 at 0 (pre-dose), , 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.
Timepoint [1] 0 0
Day 1 and Day 8
Secondary outcome [2] 0 0
Measurement of pharmacodynamic markers (cytokines and interferon-stimulated genes [ISGs]) - SAD Cohorts: whole blood and serum for pharmacodynamic (PD) assessments (RNA and cytokine analysis) will be drawn on Day 1: pre-dose and 8-hr post dose, Day 2, Day 3, Days 5 and Day 8
MAD Cohorts: whole blood and serum for PD assessments (RNA and cytokine analysis) will be drawn on Day 1: pre-dose and 8 hours postdose, Day 2, Day 3, Day 5, and Day 8: pre-dose and 8 hours post-dose, Day 9, Day 10, Day 12, and Day 15
Timepoint [2] 0 0
Up to Day 15
Secondary outcome [3] 0 0
Reduction of hepatitis B (HBV) viral load from baseline - Antiviral activity will be evaluated by determination of HBV HBsAg and HBV viral load kinetics
Timepoint [3] 0 0
Up to Day 15 and Follow-Up

Eligibility
Key inclusion criteria
- Chronic HBV infection = 6 months

- HBsAg = 250 IU/mL

- HBV treatment naïve

- Absence of extensive bridging fibrosis (Metavir 3 or greater) or cirrhosis

- Creatinine clearance = 70 mL/min
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Co-infection with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV

- History of Gilberts disease

- Laboratory parameters not within defined thresholds for leukopenia, neutropenia,
anemia, thrombocytopenia, thyroid-stimulating hormone (TSH), or other evidence of
hepatic decompensation

- Diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant
psychiatric illness, severe chronic obstructive pulmonary disease(COPD), malignancy,
hemoglobinopathy, retinal disease, or patients who are immunosuppressed

- Evidence of hepatocellular carcinoma

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [3] 0 0
Monash University, Department of Medicine - Clayton
Recruitment hospital [4] 0 0
Royal Perth Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Utah
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul
Country [16] 0 0
New Zealand
State/province [16] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2
mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and
activity rules. Subjects will be confined on either days 1-3 or days 1-3 and 8-10. Follow-up
visits are also required periodically through day 43, and potential viral load follow-up
visits at weeks 3 and 6 months post last dose. Study procedures involve blood draws for
pharmacokinetic, pharmacodynamic, virologic, and safety assessments
Trial website
https://clinicaltrials.gov/show/NCT01590641
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Benedetta Massetto, M.D.
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications