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TerminatedNCT03434353Updated Apr 4, 2022Results posted

Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB)

A Phase 2 interventional study of Inarigivir Soproxil and TAF in Chronic Hepatitis B, sponsored by Gilead Sciences. Terminated at 13 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-04-04.

Sponsored by Gilead Sciences · Phase 2, Interventional, and Treatment

Why this study was terminated
Study was terminated due to sponsor's decision to not pursue further development of inarigivir soproxil in chronic hepatitis B.
Phase
Phase 2
Study type
Interventional
Enrollment
123
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The primary objectives of this study are to evaluate the safety and tolerability of the 12 week treatment regimens of inarigivir soproxil plus tenofovir alafenamide (TAF) or commercially available nucleoside/nucleotide (NUC) in adults with chronic hepatitis B (CHB), to evaluate the antiviral activity of 12 weeks of inarigivir soproxil plus TAF versus TAF alone in viremic CHB participants (Groups 1-3, 5), and to evaluate the antiviral activity of 12 weeks of inarigivir soproxil with commercially available NUC(s) in virally suppressed CHB participants (Group 4).

02

Conditions studied

  • Chronic Hepatitis B
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Groups 1-3 and 5:

    • Individuals not taking any prescribed hepatitis B virus (HBV) NUC treatment

  • Group 4:

    • HBV deoxyribonucleic acid (DNA) ≤ 20 IU/mL at Screening by Central Lab.
    • Have been on a commercially available HBV NUC treatment(s)

Key Exclusion Criteria:

  • Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus (HDV).
  • Extensive bridging fibrosis or cirrhosis
  • Evidence of hepatocellular carcinoma on imaging
  • Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage).
  • Chronic liver disease of a non-HBV etiology
  • Current alcohol or substance abuse

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
123 participants (actual)

Study arms

  • Experimental
    Group 1: Inarigivir Soproxil 50 mg + TAF

    Viremic participants will be administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.

    Drug: Inarigivir Soproxil · Drug: TAF

  • Experimental
    Group 2: TAF

    Viremic participants will be administered TAF 25 mg tablet once daily orally with food for 48 weeks.

    Drug: TAF

  • Experimental
    Group 3: Inarigivir Soproxil 200 mg + TAF

    Viremic participants will be administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks

    Drug: Inarigivir Soproxil · Drug: TAF

  • Experimental
    Group 4: Inarigivir Soproxil 100 mg + commercially available NUCs

    Virally suppressed participants receiving commercially available nucleoside/nucleotide (NUC) will be administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants will continue commercially available NUCs for 48 weeks.

    Drug: Inarigivir Soproxil

  • Experimental
    Group 5: Inarigivir Soproxil 400 mg + TAF

    Viremic participants will be administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks.

    Drug: Inarigivir Soproxil · Drug: TAF

Interventions

  • DrugInarigivir Soproxil

    Administered orally once daily one hour before or one hour after a meal

    Also known as: SB 9200, GS-9992

  • DrugTAF

    Administered orally once daily with food

    Also known as: GS-7340, Vemlidy®

05

What researchers measure

Primary outcomes

  1. Percentage of Participants With ≥ 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1-3 and 5)

    Time frame: Baseline, Week 12

  2. Percentage of Participants With ≥ 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Group 4)

    Time frame: Baseline, Week 12

Secondary outcomes

  1. Percentage of Participants With ≥ 1 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1 Through 3 and 5)

    Time frame: Baseline, Week 12

  2. Percentage of Participants With ≥ 1 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Group 4)

    Time frame: Baseline, Week 12

  3. Percentage of HBeAg-positive Participants Who Achieved HBeAg Loss and Seroconversion at Weeks 12, 24, 36, and 48 (Groups 1 Through 3 and 5)

    HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit. HBeAg seroconversion was defined as HBeAb changing from negative or missing at baseline to positive at any postbaseline visit. Participants who had missing information were assumed to have no HBeAg loss and no HBeAg seroconversion.

    Time frame: Baseline, Weeks 12, 24, 36, and 48

  4. Percentage of HBeAg-positive Participants Who Achieved HBeAg Loss and Seroconversion at Weeks 12, 24, 36, and 48 (Group 4)

    HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit. HBeAg seroconversion was defined as HBeAb changing from negative or missing at baseline to positive at any postbaseline visit. Participants who had missing information were assumed to have no HBeAg loss and no HBeAg seroconversion.

    Time frame: Baseline, Weeks 12, 24, 36, and 48

  5. Percentage of Participants Who Achieved HBsAg Loss at Weeks 12, 24, 36, and 48 (Groups 1 Through 3 and 5)

    HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit. Participants who had missing information were assumed to have no HBeAg loss.

    Time frame: Baseline, Weeks 12, 24, 36, and 48

  6. Percentage of Participants Who Achieved HBsAg Loss at Weeks 12, 24, 36, and 48 (Group 4)

    HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit.

    Time frame: Baseline, Weeks 12, 24, 36, and 48

  7. Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Had HBV DNA ≥ 69 IU/mL (Groups 1 Through 3 and 5)

    Time frame: Baseline, Week 48

  8. Percentage of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough During 12 Weeks of Inarigivir Soproxil Treatment (Group 4)

    Virologic breakthrough was defined as HBV deoxyribonucleic acid (DNA) ≥69 IU/mL for 2 consecutive visits

    Time frame: Baseline up to Week 12

  9. Change From Baseline in HBV DNA at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5)

    Time frame: Baseline, Weeks 12, 16, 24, 36, and 48

  10. Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5)

    Time frame: Baseline, Weeks 12, 16, 24, 36, and 48

  11. Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Group 4)

    Time frame: Baseline, Weeks 12, 16, 24, 36, and 48

06

Results

Posted Apr 4, 2022

Participant flow

Participants were enrolled at study sites in Hong Kong and South Korea. The first participant was screened on 28 February 2018. The last study visit occurred on 26 January 2021.

Participant flow — Overall Study
MilestoneGroup 1: Inarigivir Soproxil 50 mg + TAFGroup 2: TAFGroup 3: Inarigivir Soproxil 200 mg + TAFGroup 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)Group 5: Inarigivir Soproxil 400 mg + TAF
Started3012302130
Completed169161812
Not completed14314318
Withdrew: Started commercial hepatitis b virus therapy10311317
Withdrew: Withdrew consent10300
Withdrew: Adverse event10001
Withdrew: Lost to follow-up20000

Outcome measures

PrimaryPercentage of Participants With ≥ 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1-3 and 5)
Time frame:
Baseline, Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With ≥ 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1-3 and 5)
percentage of participantsGroup 1: Inarigivir Soproxil 50 mg + TAFGroup 2: TAFGroup 3: Inarigivir Soproxil 200 mg + TAFGroup 5: Inarigivir Soproxil 400 mg + TAF
Percentage of Participants With ≥ 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1-3 and 5)23.3 (9.9 to 42.3)25.0 (5.5 to 57.2)0 (0.0 to 11.6)6.7 (0.8 to 22.1)
Statistical analysis
  • Group 1: Inarigivir Soproxil 50 mg + TAF vs Group 2: TAF · Percentage difference: -2.0 · 95% CI -30.4 to 26.4The percentage difference (Group 1 - Group 2) \& corresponding 2-sided 95% confidence interval (CI) were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline hepatitis B e antigen (HBeAg) status (positive,negative).
  • Group 2: TAF vs Group 3: Inarigivir Soproxil 200 mg + TAF · Percentage difference: -24.7 · 95% CI -49.2 to -0.2The percentage difference (Group 3 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).
  • Group 2: TAF vs Group 5: Inarigivir Soproxil 400 mg + TAF · Percentage difference: -17.8 · 95% CI -43.7 to 8.2The percentage difference (Group 5 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).
PrimaryPercentage of Participants With ≥ 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Group 4)
Time frame:
Baseline, Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With ≥ 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Group 4)
percentage of participantsGroup 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)
Percentage of Participants With ≥ 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Group 4)0 (0.0 to 16.1)
SecondaryPercentage of Participants With ≥ 1 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1 Through 3 and 5)
Time frame:
Baseline, Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With ≥ 1 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1 Through 3 and 5)
percentage of participantsGroup 1: Inarigivir Soproxil 50 mg + TAFGroup 2: TAFGroup 3: Inarigivir Soproxil 200 mg + TAFGroup 5: Inarigivir Soproxil 400 mg + TAF
Percentage of Participants With ≥ 1 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1 Through 3 and 5)0 (0.0 to 11.6)16.7 (2.1 to 48.4)0 (0.0 to 11.6)0 (0.0 to 11.6)
Statistical analysis
  • Group 1: Inarigivir Soproxil 50 mg + TAF vs Group 2: TAF · Percentage difference: -16.6 · 95% CI -37.7 to 4.4The percentage difference (Group 1 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).
  • Group 2: TAF vs Group 3: Inarigivir Soproxil 200 mg + TAF · Percentage difference: -16.9 · 95% CI -38.1 to 4.3The percentage difference (Group 3 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).
  • Group 2: TAF vs Group 5: Inarigivir Soproxil 400 mg + TAF · Percentage difference: -16.7 · 95% CI -37.9 to 4.4The percentage difference (Group 5 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).
SecondaryPercentage of Participants With ≥ 1 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Group 4)
Time frame:
Baseline, Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With ≥ 1 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Group 4)
percentage of participantsGroup 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)
Percentage of Participants With ≥ 1 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Group 4)0 (0.0 to 16.1)
SecondaryPercentage of HBeAg-positive Participants Who Achieved HBeAg Loss and Seroconversion at Weeks 12, 24, 36, and 48 (Groups 1 Through 3 and 5)

HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit. HBeAg seroconversion was defined as HBeAb changing from negative or missing at baseline to positive at any postbaseline visit. Participants who had missing information were assumed to have no HBeAg loss and no HBeAg seroconversion.

Time frame:
Baseline, Weeks 12, 24, 36, and 48
Reported as:
Number · percentage of participants
Percentage of HBeAg-positive Participants Who Achieved HBeAg Loss and Seroconversion at Weeks 12, 24, 36, and 48 (Groups 1 Through 3 and 5)
percentage of participantsGroup 1: Inarigivir Soproxil 50 mg + TAFGroup 2: TAFGroup 3: Inarigivir Soproxil 200 mg + TAFGroup 5: Inarigivir Soproxil 400 mg + TAF
Week 125.6000
Week 245.6000
Week 365.6000
Week 480000
SecondaryPercentage of HBeAg-positive Participants Who Achieved HBeAg Loss and Seroconversion at Weeks 12, 24, 36, and 48 (Group 4)

HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit. HBeAg seroconversion was defined as HBeAb changing from negative or missing at baseline to positive at any postbaseline visit. Participants who had missing information were assumed to have no HBeAg loss and no HBeAg seroconversion.

Time frame:
Baseline, Weeks 12, 24, 36, and 48
Reported as:
Number · percentage of participants
Percentage of HBeAg-positive Participants Who Achieved HBeAg Loss and Seroconversion at Weeks 12, 24, 36, and 48 (Group 4)
percentage of participantsGroup 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)
Week 1214.3
Week 2414.3
Week 3614.3
Week 4814.3
SecondaryPercentage of Participants Who Achieved HBsAg Loss at Weeks 12, 24, 36, and 48 (Groups 1 Through 3 and 5)

HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit. Participants who had missing information were assumed to have no HBeAg loss.

Time frame:
Baseline, Weeks 12, 24, 36, and 48
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieved HBsAg Loss at Weeks 12, 24, 36, and 48 (Groups 1 Through 3 and 5)
percentage of participantsGroup 1: Inarigivir Soproxil 50 mg + TAFGroup 2: TAFGroup 3: Inarigivir Soproxil 200 mg + TAFGroup 5: Inarigivir Soproxil 400 mg + TAF
Week 120000
Week 240000
Week 360000
Week 480000
SecondaryPercentage of Participants Who Achieved HBsAg Loss at Weeks 12, 24, 36, and 48 (Group 4)

HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit.

Time frame:
Baseline, Weeks 12, 24, 36, and 48
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieved HBsAg Loss at Weeks 12, 24, 36, and 48 (Group 4)
percentage of participantsGroup 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)
Week 120
Week 240
Week 360
Week 480
SecondaryNumber of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Had HBV DNA ≥ 69 IU/mL (Groups 1 Through 3 and 5)
Time frame:
Baseline, Week 48
Reported as:
Count of participants · Participants
Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Had HBV DNA ≥ 69 IU/mL (Groups 1 Through 3 and 5)
ParticipantsGroup 1: Inarigivir Soproxil 50 mg + TAFGroup 2: TAFGroup 3: Inarigivir Soproxil 200 mg + TAFGroup 5: Inarigivir Soproxil 400 mg + TAF
Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Had HBV DNA ≥ 69 IU/mL (Groups 1 Through 3 and 5)4004
SecondaryPercentage of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough During 12 Weeks of Inarigivir Soproxil Treatment (Group 4)

Virologic breakthrough was defined as HBV deoxyribonucleic acid (DNA) ≥69 IU/mL for 2 consecutive visits

Time frame:
Baseline up to Week 12
Reported as:
Number · percentage of participants
Percentage of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough During 12 Weeks of Inarigivir Soproxil Treatment (Group 4)
percentage of participantsGroup 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)
Percentage of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough During 12 Weeks of Inarigivir Soproxil Treatment (Group 4)0
SecondaryChange From Baseline in HBV DNA at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5)
Time frame:
Baseline, Weeks 12, 16, 24, 36, and 48
Reported as:
Mean · log10 IU/mL
Change From Baseline in HBV DNA at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5)
log10 IU/mLGroup 1: Inarigivir Soproxil 50 mg + TAFGroup 2: TAFGroup 3: Inarigivir Soproxil 200 mg + TAFGroup 5: Inarigivir Soproxil 400 mg + TAF
Baseline7.06 ± 1.5307.06 ± 1.7576.30 ± 1.3656.61 ± 1.479
Change at Week 12-4.18 ± 0.959-4.24 ± 1.340-4.02 ± 0.854-3.93 ± 0.817
Change at Week 16-4.58 ± 1.023-4.65 ± 1.326-4.29 ± 0.946-4.23 ± 0.869
Change at Week 24-5.02 ± 1.101-5.25 ± 1.510-4.67 ± 1.049-4.76 ± 1.013
Change at Week 36-5.27 ± 1.194-5.53 ± 1.610-4.78 ± 1.207-4.92 ± 1.129
Change at Week 48-5.36 ± 1.225-5.25 ± 1.839-4.83 ± 1.162-4.93 ± 1.370
SecondaryChange From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5)
Time frame:
Baseline, Weeks 12, 16, 24, 36, and 48
Reported as:
Mean · log10 IU/mL
Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5)
log10 IU/mLGroup 1: Inarigivir Soproxil 50 mg + TAFGroup 2: TAFGroup 3: Inarigivir Soproxil 200 mg + TAFGroup 5: Inarigivir Soproxil 400 mg + TAF
Baseline3.933 ± 0.80584.118 ± 0.65433.529 ± 0.88353.418 ± 0.8075
Change at Week 12-0.244 ± 0.3443-0.435 ± 0.53200.016 ± 0.2850-0.026 ± 0.3805
Change at Week 16-0.282 ± 0.3954-0.479 ± 0.54290.014 ± 0.2916-0.082 ± 0.4262
Change at Week 24-0.310 ± 0.4303-0.482 ± 0.5119-0.021 ± 0.3171-0.104 ± 0.5000
Change at Week 36-0.330 ± 0.4363-0.524 ± 0.5430-0.055 ± 0.4213-0.209 ± 0.5319
Change at Week 48-0.322 ± 0.4311-0.517 ± 0.5617-0.045 ± 0.4778-0.235 ± 0.5429
SecondaryChange From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Group 4)
Time frame:
Baseline, Weeks 12, 16, 24, 36, and 48
Reported as:
Mean · log10 IU/mL
Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Group 4)
log10 IU/mLGroup 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)
Baseline3.211 ± 0.5536
Change at Week 12-0.017 ± 0.0417
Change at Week 16-0.010 ± 0.0645
Change at Week 24-0.039 ± 0.0925
Change at Week 36-0.037 ± 0.0939
Change at Week 48-0.073 ± 0.1120

Adverse events

Collected over All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1: Inarigivir Soproxil 50 mg + TAF0/30 (0%)1/30 (3.3%)8/30 (26.7%)
Group 2: TAF0/12 (0%)1/12 (8.3%)7/12 (58.3%)
Group 3: Inarigivir Soproxil 200 mg + TAF0/30 (0%)1/30 (3.3%)15/30 (50%)
Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)0/21 (0%)0/21 (0%)9/21 (42.9%)
Group 5: Inarigivir Soproxil 400 mg + TAF0/30 (0%)1/30 (3.3%)9/30 (30%)
Most frequent serious events
Most frequent serious events
EventGroup 1: Inarigivir Soproxil 50 mg + TAFGroup 2: TAFGroup 3: Inarigivir Soproxil 200 mg + TAFGroup 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)Group 5: Inarigivir Soproxil 400 mg + TAF
Carpal tunnel syndromeNervous system disorders0/301/120/300/210/30
Abdominal pain upperGastrointestinal disorders0/300/121/300/210/30
Campylobacter gastroenteritisInfections and infestations1/300/120/300/210/30
Alanine aminotransferase increasedInvestigations0/300/120/300/211/30
Most frequent other events
Showing 10 of 18
Most frequent other events
EventGroup 1: Inarigivir Soproxil 50 mg + TAFGroup 2: TAFGroup 3: Inarigivir Soproxil 200 mg + TAFGroup 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)Group 5: Inarigivir Soproxil 400 mg + TAF
Influenza like illnessGeneral disorders0/300/122/306/211/30
Upper respiratory tract infectionInfections and infestations1/303/126/301/213/30
Alanine aminotransferase increasedInvestigations4/301/121/301/210/30
HeadacheNervous system disorders1/300/123/300/212/30
Productive coughRespiratory, thoracic and mediastinal disorders0/300/121/300/213/30
InfluenzaInfections and infestations1/300/120/302/210/30
VertigoEar and labyrinth disorders0/301/120/300/210/30
Hepatic steatosisHepatobiliary disorders0/301/120/300/210/30
Tooth fractureInjury, poisoning and procedural complications0/301/120/300/210/30
MyalgiaMusculoskeletal and connective tissue disorders0/301/120/300/210/30

Baseline characteristics

The Safety Analysis Set included all participants who took at least 1 dose of any study drug.

Age, Customized
Age, Customized(Participants)Group 1: Inarigivir Soproxil 50 mg + TAFGroup 2: TAFGroup 3: Inarigivir Soproxil 200 mg + TAFGroup 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)Group 5: Inarigivir Soproxil 400 mg + TAFTotal
<50 years23519111371
≥50 years7711101752
Sex: Female, Male
Sex: Female, Male(Participants)Group 1: Inarigivir Soproxil 50 mg + TAFGroup 2: TAFGroup 3: Inarigivir Soproxil 200 mg + TAFGroup 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)Group 5: Inarigivir Soproxil 400 mg + TAFTotal
Female1231191146
Male18919121977
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Group 1: Inarigivir Soproxil 50 mg + TAFGroup 2: TAFGroup 3: Inarigivir Soproxil 200 mg + TAFGroup 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)Group 5: Inarigivir Soproxil 400 mg + TAFTotal
Hispanic or Latino000000
Not Hispanic or Latino3012302130123
Unknown or Not Reported000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Group 1: Inarigivir Soproxil 50 mg + TAFGroup 2: TAFGroup 3: Inarigivir Soproxil 200 mg + TAFGroup 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)Group 5: Inarigivir Soproxil 400 mg + TAFTotal
American Indian or Alaska Native000000
Asian3012302130123
Native Hawaiian or Other Pacific Islander000000
Black or African American000000
White000000
More than one race000000
Unknown or Not Reported000000
Region of Enrollment
Region of Enrollment(participants)Group 1: Inarigivir Soproxil 50 mg + TAFGroup 2: TAFGroup 3: Inarigivir Soproxil 200 mg + TAFGroup 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)Group 5: Inarigivir Soproxil 400 mg + TAFTotal
Hong Kong8522113076
South Korea227810047
Hepatitis B Surface Antigen (HBsAg) Category
Hepatitis B Surface Antigen (HBsAg) Category(Participants)Group 1: Inarigivir Soproxil 50 mg + TAFGroup 2: TAFGroup 3: Inarigivir Soproxil 200 mg + TAFGroup 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)Group 5: Inarigivir Soproxil 400 mg + TAFTotal
≤ 4 log10 IU/mL16423192183
> 4 log10 IU/mL14872940
07

Study locations

13 sites
  • Alice Ho Miu Ling Nethersole Hospital
    Hong Kong, Hong Kong
  • Prince Margaret Hospital
    Hong Kong, Hong Kong
  • Prince of Wales Hospital-HK
    Hong Kong, Hong Kong
  • Korea University Ansan Hospital
    Ansan, 425-707, Korea, Republic of
  • Keimyung University Dongsan Medical Center
    Daegu, 41931, Korea, Republic of
  • Kyungpook National University Hospital
    Daegu, 41944, Korea, Republic of
  • Inje University Ilsan Paik Hospital
    Ilsan, 10380, Korea, Republic of
  • Severance Hospital, Yonsei University Health System
    Seoul, 03722, Korea, Republic of
  • Asan Medical Center
    Seoul, 05505, Korea, Republic of
  • Gangnam Severance Hospital, Yonsei University Health System
    Seoul, 06273, Korea, Republic of
  • Catholic University of Korea, Seoul Saint Mary's Hospital
    Seoul, 06591, Korea, Republic of
  • SMG-SNU Boramae Medical Center
    Seoul, 07061, Korea, Republic of
  • Korea University Guro Hospital
    Seoul, 08308, Korea, Republic of
08

References and documents

Publications

  • Lim YS, Hui AJ, Jang JW, Tak WY, Ahn SH, Jang BK, et al. Safety, efficacy, & pharmacodynamic (PD) activity of 12 weeks treatment with oral RIG-I agonist, inarigivir (IRIG), plus 48 weeks of tenofovir alafenamide in adult patients with chronic hepatitis B: a phase 2 collaboration study [Abstract PO-2422]. The International Liver Congress: European Association for the Study of the Liver (EASL) Virtual; 2021 23-26 June.

Study documents

  • Study protocol · Mar 11, 2019
  • Statistical analysis plan · Sep 22, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03434353
Lead sponsor
Gilead Sciences
Collaborators
F-star Therapeutics, Inc.
Responsible party
Sponsor
First posted
Feb 15, 2018
Start date
Feb 28, 2018
Primary completion
Jan 20, 2020
Completion
Jan 26, 2021
Results posted
Apr 4, 2022
Last update
Apr 4, 2022

Study contacts

Gilead Study Director
study director · Gilead Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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