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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01590654




Registration number
NCT01590654
Ethics application status
Date submitted
30/04/2012
Date registered
3/05/2012
Date last updated
20/12/2013

Titles & IDs
Public title
A Study Evaluating GS-9620 in Virologically Suppressed Subjects With Chronic Hepatitis B Virus Infection
Scientific title
A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Activity of GS-9620 in Virologically Suppressed Subjects With Chronic Hepatitis B Virus Infection
Secondary ID [1] 0 0
GS-US-283-0102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B 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 GS-9620

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 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 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
Timepoint [1] 0 0
Periodically Day 1 to 6 months
Secondary outcome [1] 0 0
Assessment of plasma drug concentrations of GS-9620 using non-compartmental methods
Timepoint [1] 0 0
Day 1 and Day 8
Secondary outcome [2] 0 0
Measurement of pharmacodynamic markers (cytokines and interferon-stimulated genes [ISGs])
Timepoint [2] 0 0
Days 1, 2, 3, 5, 8
Secondary outcome [3] 0 0
Reduction of hepatitis B (HBV) viral load from baseline
Timepoint [3] 0 0
Screening, Baseline, Day 8 or 15

Eligibility
Key inclusion criteria
- Chronic HBV infection for = 6 months

- Currently on treatment with at least 1 HBV approved oral drug (i.e. lamivudine,
telbivudine, entecavir, adefovir, tenofovir) = 3 months prior to screening

- HBsAg = 250 IU/mL

- HBV DNA at below the level of quantitation (BLQ; to be confirmed at screening)

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

- Creatinine clearance = 70 mL/min
Minimum age
18 Years
Maximum age
65 Years
Sex
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
1/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2013
Sample size
Target
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Nepean Hospital, Department of ID - Kingswood
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [3] 0 0
Monash University, Dept. of Medicine - Clayton
Recruitment hospital [4] 0 0
Alfred Hospital, Department of Gastroenterology - Melbourne
Recruitment hospital [5] 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
3004 - Melbourne
Recruitment postcode(s) [5] 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
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Utah
Country [10] 0 0
Canada
State/province [10] 0 0
Alberta
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Seoul
Country [13] 0 0
New Zealand
State/province [13] 0 0
Aukland

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 days 1-3 and/or days 8-10. Follow-up visits are
required periodically through day 43. Subjects with sustained reductions in HbsAg will be
requested to return for additional follow-up follow-up visits at 3 and 6 months post last
dose. Study procedures involve blood draws for pharmacokinetic, pharmacodynamic, virologic,
and safety assessments
Trial website
https://clinicaltrials.gov/ct2/show/NCT01590654
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01590654