Clinical Trial Results:
A Phase 2, Open-label, Multicenter Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Treatment With JNJ-73763989, Nucleos(t)ide Analogs, and Pegylated Interferon Alpha-2a in Patients With Chronic Hepatitis B Virus Infection
|
Summary
|
|
EudraCT number |
2021-002450-81 |
Trial protocol |
ES PL |
Global end of trial date |
29 Dec 2021
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
12 Jan 2023
|
First version publication date |
12 Jan 2023
|
Other versions |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
73763989PAHPB2007
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT05005507 | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
Janssen Research & Development, LLC
|
||
Sponsor organisation address |
920 US Highway 202, Raritan, NJ, United States, 08869-1420
|
||
Public contact |
Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
|
||
Scientific contact |
Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
29 Dec 2021
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
29 Dec 2021
|
||
Was the trial ended prematurely? |
Yes
|
||
|
General information about the trial
|
|||
Main objective of the trial |
The main objective of this study was to evaluate the efficacy in terms of hepatitis B surface antigen (HBsAg) changes from baseline for the treatment regimens of 24 weeks of JNJ-73763989 (JNJ-3989) + 24 weeks of nucleos(t)ide analog (NA) + 12 or 24 weeks of pegylated interferon alpha-2a (PegIFN-alpha-2a) (with immediate or delayed start of PegIFN-alpha-2a treatment), as compared to NA standard of care treatment.
|
||
Protection of trial subjects |
This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Nov 2021
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Poland: 1
|
||
Worldwide total number of subjects |
1
|
||
EEA total number of subjects |
1
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
1
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
||
|
|||||||||||
|
Recruitment
|
|||||||||||
Recruitment details |
- | ||||||||||
|
Pre-assignment
|
|||||||||||
Screening details |
Only 1 subject was enrolled in the study in Arm 1: JNJ-73763989 + nucleos(t)ide analog (NA) + pegylated interferon alpha-2a (PegIFN-alpha-2a). Subjects were also planned to be enrolled in Arms 2 and 3 but were not enrolled as the study discontinued prematurely based on a strategic decision and not for safety reasons. None completed the study. | ||||||||||
|
Period 1
|
|||||||||||
Period 1 title |
Overall Study (overall period)
|
||||||||||
Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Randomised - controlled
|
||||||||||
Blinding used |
Not blinded | ||||||||||
|
Arms
|
|||||||||||
|
Arm title
|
Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a | ||||||||||
Arm description |
Subject received JNJ-73763989 200 milligrams (mg) subcutaneous (SC) injection on Day 1 plus NA treatment (entecavir [ETV] 0.5 mg tablet) orally once daily from Day 1 to Day 16 plus pegylated interferon alpha-2a (PegIFN-alpha-2a) 180 micrograms (mcg) SC injection on Days 1, 8, and 15. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
JNJ-73763989
|
||||||||||
Investigational medicinal product code |
|||||||||||
Other name |
|||||||||||
Pharmaceutical forms |
Injection
|
||||||||||
Routes of administration |
Subcutaneous use
|
||||||||||
Dosage and administration details |
JNJ-73763989 200 mg injection was administered subcutaneously on Day 1.
|
||||||||||
Investigational medicinal product name |
PegIFN-alpha-2a
|
||||||||||
Investigational medicinal product code |
|||||||||||
Other name |
|||||||||||
Pharmaceutical forms |
Injection
|
||||||||||
Routes of administration |
Subcutaneous use
|
||||||||||
Dosage and administration details |
PegIFN-alpha-2a 180 mcg injection was administered subcutaneously on Days 1, 8, and 15.
|
||||||||||
Investigational medicinal product name |
Entecavir
|
||||||||||
Investigational medicinal product code |
|||||||||||
Other name |
|||||||||||
Pharmaceutical forms |
Tablet
|
||||||||||
Routes of administration |
Oral use
|
||||||||||
Dosage and administration details |
NA treatment entecavir (ETV) 0.5 mg tablet was administered
orally once daily from Day 1 to Day 16.
|
||||||||||
|
|||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subject received JNJ-73763989 200 milligrams (mg) subcutaneous (SC) injection on Day 1 plus NA treatment (entecavir [ETV] 0.5 mg tablet) orally once daily from Day 1 to Day 16 plus pegylated interferon alpha-2a (PegIFN-alpha-2a) 180 micrograms (mcg) SC injection on Days 1, 8, and 15. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
|
||
Reporting group description |
Subject received JNJ-73763989 200 milligrams (mg) subcutaneous (SC) injection on Day 1 plus NA treatment (entecavir [ETV] 0.5 mg tablet) orally once daily from Day 1 to Day 16 plus pegylated interferon alpha-2a (PegIFN-alpha-2a) 180 micrograms (mcg) SC injection on Days 1, 8, and 15. | ||
|
|||||||||
End point title |
Percentage of Subjects with a Reduction of at least 2log10 International Units Per Millilitre (IU/mL) in Hepatitis B Surface Antigen (HBsAg) Levels from Baseline at Week 24 (End of Study Intervention [EOSI]) [1] | ||||||||
End point description |
Percentage of subjects with a reduction of at least 2log10 IU/mL in HBsAg levels from baseline at Week 24 (EOSI) were reported. Full analysis set (FAS) included all subjects who were randomly assigned to an intervention arm in the intervention-specific appendix (ISA) and received at least 1 dose of study intervention. Subjects were analysed according to the study intervention they were randomly assigned to.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Week 24
|
||||||||
| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics was done, no inferential statistical analysis was performed. |
|||||||||
|
|||||||||
| Notes [2] - This endpoint was not assessed due to premature termination of the study prior to Week 24. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Subjects with Adverse Events (AEs) | ||||||||
End point description |
An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. Safety analysis set included all subjects who received at least 1 dose of study intervention within the ISA. Subjects were analysed according to the study intervention they actually received.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to 1 month 26 days
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Subjects with Serious Adverse Events (SAEs) | ||||||||
End point description |
SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. Safety analysis set included all subjects who received at least 1 dose of study intervention within the ISA. Subjects were analysed according to the study intervention they actually received.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to 1 month 26 days
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Subjects with Abnormalities in Clinical Laboratory Tests | ||||||||
End point description |
Percentage of subjects with abnormalities in clinical laboratory tests including hematology, blood biochemistry, blood coagulation, urinalysis, urine chemistry, renal biomarkers) were reported. Safety analysis set included all subjects who received at least 1 dose of study intervention within the ISA. Subjects were analysed according to the study intervention they actually received.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to 1 month 26 days
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Subjects with Abnormalities in 12-Lead Electrocardiograms (ECGs) | ||||||||
End point description |
Percentage of subjects with abnormalities in 12-Lead ECGs were reported. Safety analysis set included all subjects who received at least 1 dose of study intervention within the ISA. Subjects were analysed according to the study intervention they actually received.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to 1 month 26 days
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Subjects with Abnormalities in Vital Signs | ||||||||
End point description |
Percentage of subjects with abnormalities in vital signs were reported. Safety analysis set included all subjects who received at least 1 dose of study intervention within the ISA. Subjects were analysed according to the study intervention they actually received.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to 1 month 26 days
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Subjects with Abnormalities in Ophthalmologic Examination | ||||||||
End point description |
Percentage of subjects with abnormalities in ophthalmologic examination were reported. Safety analysis set included all subjects who received at least 1 dose of study intervention within the ISA. Subjects were analysed according to the study intervention they actually received.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Weeks 8 and 20
|
||||||||
|
|||||||||
| Notes [3] - This endpoint was not assessed due to premature termination of the study prior to Weeks 8 and 20. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Subjects with Abnormalities in Physical Examination | ||||||||
End point description |
Percentage of subjects with abnormalities in physical examination were reported. Safety analysis set included all subjects who received at least 1 dose of study intervention within the ISA. Subjects were analysed according to the study intervention they actually received.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Week 24
|
||||||||
|
|||||||||
| Notes [4] - This endpoint was not assessed due to premature termination of the study prior to Week 24. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Subjects Meeting the Protocol- defined Nucleos(t)ide Analog (NA) Treatment Completion Criteria Based on the Week 24 (EOSI) or Follow-up (FU) Week 2 Results | ||||||||
End point description |
Percentage of subjects meeting the protocol- defined NA treatment completion criteria based on the Week 24 (EOSI) or FU Week 2 results were reported. NA treatment completion criteria were as follows: (a) subject had ALT <3*upper limits of normal (ULN); (b) subject had HBV DNA <20 IU/mL; (c) subject was HBeAg-negative; (d) subject had HBsAg <10 International units per milliliter (IU/mL). FAS included all subjects who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. Subjects were analysed according to the study intervention they were randomly assigned to.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Week 24 (EOSI) and FU Week 2
|
||||||||
|
|||||||||
| Notes [5] - Endpoint was not assessed due to premature termination of study prior Week 24 (EOSI) and FU Week 2. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Subjects with HBsAg Seroclearance at FU Weeks 24 and 48 without Re-starting NA Treatment | ||||||||
End point description |
Percentage of subjects with HBsAg seroclearance at FU Weeks 24 and 48 without re-starting NA treatment were reported. Seroclearance of HBsAg is defined as a (quantitative) HBsAg level <LLOQ. FAS included all subjects who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. Subjects were analyzed according to the study intervention they were randomly assigned to.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Follow-up Weeks 24 and 48
|
||||||||
|
|||||||||
| Notes [6] - This endpoint was not assessed due to premature termination of study prior to FU Weeks 24 and 48. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Subjects with Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < (Less Than) Lower Limit of Quantification (LLOQ) at FU Weeks 24 and 48 Without Re-starting NA Treatment | ||||||||
End point description |
Percentage of subjects with HBV DNA <LLOQ at FU Weeks 24 and 48 without re-starting NA treatment were reported. FAS included all subjects who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. Subjects were analysed according to the study intervention they were randomly assigned to.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
FU Weeks 24 and 48
|
||||||||
|
|||||||||
| Notes [7] - This endpoint was not assessed due to premature termination of study prior to FU Weeks 24 and 48. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Subjects with Virologic Flares | ||||||||
End point description |
Percentage of subjects with virologic flares were reported. FAS included all subjects who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. Subjects were analyzed according to the study intervention they were randomly assigned to.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to 1 month 26 days
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Subjects with Biochemical Flares | ||||||||
End point description |
Percentage of subjects with biochemical flares were reported. FAS included all subjects who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. Subjects were analyzed according to the study intervention they were randomly assigned to.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to 1 month 26 days
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Subjects Requiring NA Re-treatment | ||||||||
End point description |
Percentage of subjects requiring NA re-treatment were reported. FAS included all subjects who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. Subjects were analyzed according to the study intervention they were randomly assigned to.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to 72 weeks
|
||||||||
|
|||||||||
| Notes [8] - This endpoint was not assessed due to premature termination of the study prior to 72 weeks. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Subjects with HBsAg, Hepatitis B e Antigen (HBeAg), HBV DNA, and Alanine Aminotransferase (ALT) Levels Below/Above Different Cut-offs Over Time | ||||||||
End point description |
Percentage of subjects with HBsAg, HBeAg, HBV DNA, and ALT levels below/above different cut-offs over time were reported. FAS included all subjects who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. Subjects were analyzed according to the study intervention they were randomly assigned to.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to 72 weeks
|
||||||||
|
|||||||||
| Notes [9] - This endpoint was not assessed due to premature termination of the study prior to 72 weeks. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Subjects with HBsAg Seroconversion | ||||||||
End point description |
Percentage of subjects with HBsAg seroconversion were reported. Seroconversion of HBsAg is defined as having achieved HBsAg seroclearance and appearance of
anti-HBs antibodies. FAS included all subjects who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. Subjects were analyzed according to the study intervention they were randomly assigned to.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to 72 weeks
|
||||||||
|
|||||||||
| Notes [10] - This endpoint was not performed due to premature termination of the study prior to 72 weeks. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Baseline in HBsAg Over Time | ||||||||
End point description |
Change from baseline in HBsAg over time were reported. FAS included all subjects who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. Subjects were analysed according to the study intervention they were randomly assigned to.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline up to Week 72
|
||||||||
|
|||||||||
| Notes [11] - This endpoint was not assessed due to premature termination of the study prior to Week 72. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Time to Achieve HBV DNA <LLOQ | ||||||||
End point description |
Time to achieve HBV DNA <LLOQ were reported. FAS included all subjects who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. Subjects were analysed according to the study intervention they were randomly assigned to.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to 72 weeks
|
||||||||
|
|||||||||
| Notes [12] - This endpoint was not assessed due to premature termination of the study prior to 72 weeks. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Time to Achieve HBsAg Seroclearance/ Seroconversion | ||||||||
End point description |
Time to achieve HBsAg seroclearance/ seroconversion were reported. FAS included all subjects who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. Subjects were analysed according to the study intervention they were randomly assigned to.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to 72 weeks
|
||||||||
|
|||||||||
| Notes [13] - This endpoint was not performed due to premature termination of the study prior to 72 weeks. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Serum Concentration of JNJ-73763989 (JNJ-73763924 and JNJ-73763976) | ||||||||
End point description |
Serum concentration of JNJ-73763989 (JNJ-73763924 and JNJ-73763976) were reported. Pharmacokinetics (PK) analysis set included all subjects who received at least 1 dose of study intervention and have at least 1 valid blood sample drawn for PK analysis.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Days 1, 29, 85, 113, 169
|
||||||||
|
|||||||||
| Notes [14] - This endpoint was not assessed due to premature termination of the study. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Subjects with Virologic Breakthrough | ||||||||
End point description |
Percentage of subjects with virologic breakthrough were reported. FAS included all subjects who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. Subjects were analysed according to the study intervention they were randomly assigned to.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to Week 24
|
||||||||
|
|||||||||
| Notes [15] - This endpoint was not assessed due to premature termination of the study prior to Week 24. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Serum Concentration of NA (Entecavir [ETV]) | ||||||||
End point description |
Serum concentration of NA (ETV) were reported. PK analysis set included all subjects who received at least 1 dose of study intervention and have at least 1 valid blood sample drawn for PK analysis.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Days 1, 29, 85, 113, 169
|
||||||||
|
|||||||||
| Notes [16] - This endpoint was not assessed due to premature termination of the study. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Serum Concentration of PegIFN-alpha-2a | ||||||||
End point description |
Serum concentration of PegIFN-alpha-2a were reported. PK analysis set included all subjects who received at least 1 dose of study intervention and have at least 1 valid blood sample drawn for PK analysis.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Days 1, 29, 85, 113, 169
|
||||||||
|
|||||||||
| Notes [17] - This endpoint was not assessed due to premature termination of the study. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||
|
Adverse events information [1]
|
|||||||||||
Timeframe for reporting adverse events |
Up to 1 month 26 days
|
||||||||||
Adverse event reporting additional description |
Safety analysis set included all subjects who received at least 1 dose of study intervention within this intervention-specific appendix (ISA). Subjects were analysed according to the study intervention they actually received.
|
||||||||||
Assessment type |
Systematic | ||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||
Dictionary name |
MedDRA | ||||||||||
Dictionary version |
24.1
|
||||||||||
|
Reporting groups
|
|||||||||||
Reporting group title |
Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
|
||||||||||
Reporting group description |
Subject received JNJ-73763989 200 milligrams (mg) subcutaneous (SC) injection on Day 1 plus NA treatment (entecavir [ETV] 0.5 mg tablet) orally once daily from Day 1 to Day 16 plus pegylated interferon alpha-2a (PegIFN-alpha-2a) 180 micrograms (mcg) SC injection on Days 1, 8, and 15. | ||||||||||
|
|||||||||||
| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||
|
|||||||||||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Data could not be reported as only 1 subject was enrolled in the study who did not experience any non-serious adverse event. |
|||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
06 Oct 2021 |
The primary reasons for this amendment was to include pre-specified nucleos(t)ide analog (NA) treatment completion criteria, and to add a new NA re-treatment criterion and more frequent monitoring for subjects who met the NA treatment completion criteria based on the Week 24 (or Follow-up Week 2) results and discontinued NA treatment during follow-up. |
||
01 Dec 2021 |
The primary reason for this amendment was to update the criteria for post-treatment monitoring and for nucleos(t)ide analog (NA) re-treatment for subjects who discontinued NA treatment at Follow-up Week 2. |
||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
