A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B

Gilead Sciences

Status and phase: Completed; Phase 1

Conditions: Hepatitis B; HBV

Treatments: Drug: Multiple Ascending Dose (MAD) Cohorts; Drug: Single Ascending Dose (SAD) Cohorts GS-9620

Study type: Interventional

Funder types: Industry

Identifiers

NCT01590641

GS-US-283-0106

Details and patient eligibility

About

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

Enrollment: 49 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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49 participants in 8 patient groups

0.3mg GS-9620

Experimental group

Treatment:

Drug: Single Ascending Dose (SAD) Cohorts GS-9620

1mg GS-9620

Experimental group

Treatment:

Drug: Single Ascending Dose (SAD) Cohorts GS-9620

2mg GS-9620

Experimental group

Treatment:

Drug: Single Ascending Dose (SAD) Cohorts GS-9620

4mg GS-9620

Experimental group

Treatment:

Drug: Single Ascending Dose (SAD) Cohorts GS-9620

0.3mg GS-9620 QW x 2 doses

Experimental group

Treatment:

Drug: Multiple Ascending Dose (MAD) Cohorts

1mg GS-9620 QW x 2 doses

Experimental group

Treatment:

Drug: Multiple Ascending Dose (MAD) Cohorts

2mg GS-9620 QW x 2 doses

Experimental group

Treatment:

Drug: Multiple Ascending Dose (MAD) Cohorts

4mg GS-9620 QW x 2 doses

Experimental group

Treatment:

Drug: Multiple Ascending Dose (MAD) Cohorts